KWAFDA Class 3 · 21 CFR 888.3330 · implantable
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device family · Orthopedic
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
114
Manufacturers
18
Flagged signals
20
Adverse-event reports
135,759
Code matrix
| FDA product code | KWA |
| Device class | Class 3 |
| Regulation | 21 CFR 888.3330 |
| GMDN | — (crosswalk pending) |
| Implantable | Yes |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2014 | 9 | 498.8 | 3,993 |
| Death | 2011 | 6 | 113.5 | 566 |
| Other | 2014 | 989 | 82.2 | 76,994 |
| Other | 2013 | 38 | 71.9 | 2,586 |
| Other | 2012 | 35 | 66.2 | 2,183 |
| Other | 2010 | 33 | 62.4 | 1,934 |
| Other | 2011 | 26 | 49.2 | 1,180 |
| Other | 2012 | 421 | 34.4 | 13,459 |
| Other | 2013 | 321 | 26.1 | 7,671 |
| Other | 2014 | 7 | 13.2 | 67 |
| Other | 2011 | 100 | 8.1 | 613 |
| Other | 2015 | 87 | 7.0 | 444 |
| Other | 2015 | 3 | 5.7 | 7 |
| Other | 2011 | 3 | 5.7 | 7 |
| Death | 2013 | 6 | 5.4 | 17 |
| Other | 2012 | 41 | 3.3 | 64 |
| Other | 2011 | 33 | 2.7 | 33 |
| Injury | 2016 | 4 | 2.6 | 4 |
| Injury | 2013 | 19 | 2.3 | 20 |
| Injury | 2011 | 6 | 2.2 | 5 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 3 family · 135,759 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Wrightmedicaltechnologyinc | 26 | 2012 | — |
| Biomet Manufacturing Corp | 13 | 2011 | — |
| DEPUY ORTHOPAEDICS, INC. | 12 | 2009 | — |
| Biomet, Inc. | 11 | 2010 | — |
| Encore Medical L.P. | 5 | 2010 | — |
| Zimmer GmbH | 5 | 2011 | — |
| Zimmer, Inc. | 4 | 2008 | — |
| Sulzer Orthopedics, Inc. | 3 | 2001 | — |
| Osteonics Corp. | 3 | 1988 | — |
| WALDEMAR LINK GmbH & Co. KG | 2 | 1985 | — |
| Downs Surgical , Ltd. | 2 | 1987 | — |
| Pfizer, Inc. | 1 | 1985 | — |
| Kirschner Medical Corp. | 1 | 1985 | — |
| Kinamed, Inc. | 1 | 1988 | — |
| Depuy, Inc. | 1 | 1985 | — |
| Sulzermedica | 1 | 1999 | — |
| Howmedica Corp. | 1 | 1978 | — |
| Encore Orthopedics, Inc. | 1 | 2001 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
PROFEMUR Z REVISION HIP STEM · Wrightmedicaltechnologyinc510(k) · 2012-10-11
DYNASTY BIOFOAM SHELL · Wrightmedicaltechnologyinc510(k) · 2012-07-30
METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS · Biomet Manufacturing, Inc.510(k) · 2012-05-18
CONSERVE THIN SHELL · Wrightmedicaltechnologyinc510(k) · 2012-02-03
PRESERVE HIP STEM · Wrightmedicaltechnologyinc510(k) · 2011-12-28
PROFEMUR GLADIATOR HA HIP STEM · Wrightmedicaltechnologyinc510(k) · 2011-11-23
PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER · Wrightmedicaltechnologyinc510(k) · 2011-11-10
GLADIATOR HIP STEM · Wrightmedicaltechnologyinc510(k) · 2011-10-14
CLS BREVIUS STEM WITH KINECTIV TECHNOLOGY · Zimmer GmbH510(k) · 2011-10-07
TAPERLOC COMPLETE MICROPLASTY STEM · Biomet Manufacturing Corp510(k) · 2011-09-30
PROFEMUR(R) E CEMENTLESS HIP STEM · Wrightmedicaltechnologyinc510(k) · 2011-08-19
PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM · Wrightmedicaltechnologyinc510(k) · 2011-08-19
GLADIATOR PLASMA CLASSIC HIP STEM · Wrightmedicaltechnologyinc510(k) · 2011-05-10
CONSERVE BIO FOAM SHELL · Wrightmedicaltechnologyinc510(k) · 2011-04-19
TAPERLOC COMPLETE, SIZE 5 AND 6 · Biomet Manufacturing Corp510(k) · 2011-01-21
ANTERIOR APPROACH HIP SURGERY INSTRUMENTS · Wrightmedicaltechnologyinc510(k) · 2010-12-22
ARCOS INTERLOCKING DISTAL STEMS · Biomet Manufacturing Corp510(k) · 2010-12-07
TAPERLOC COMPLETE · Biomet, Inc.510(k) · 2010-09-03
COMPRESS ANTI-ROTATION SPINDLES · Biomet Manufacturing Corp510(k) · 2010-06-18
RINGLOC + HYBRID ACETABULAR SYSTEM · Biomet, Inc.510(k) · 2010-04-30
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; · Encore Medical L.P.510(k) · 2010-03-03
ZIMMER MMC CUP · Zimmer GmbH510(k) · 2009-11-24
METASUL TAPER LINERS, METASUL FEMORAL HEADS · Zimmer GmbH510(k) · 2009-11-17
BIOMET MODULAR FEMORAL REVISION SYSTEM · Biomet, Inc.510(k) · 2009-09-25
PROFEMUR HIP SYSTEM MODULAR NECKS · Wrightmedicaltechnologyinc510(k) · 2009-08-25
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.