Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
Orthopedic · 21 CFR 888.3320
Recent MDR events
3,885 adverse event reports on file
- PROFEMUR® NECK A/R 8DG LONG COBALT CHROMEJul 29, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00406
- PROFEMUR® NECK A/R 8DG LONG COBALT CHROMEJul 28, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00321
- COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER MEDIUMJul 28, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00404
- COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER LONG NJul 28, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00398
- COCR TRANSCEND® FEMORAL HEAD 36MM SLT TAPER SHORTJul 27, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00252
- PROFEMUR® NECK NEUTRAL LONG COBALT CHROMEJul 27, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00264
- PROFEMUR® NECK A/R VAR/VAL 1 LONG COBALT CHROMEJul 27, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00282
- EVOLUTION®MP TIB KEELED NONPOR SIZE 8 STANDARD LEFJul 27, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00317
- PROFEMUR® NECK A/R VAR/VAL 2 SHORT COBALT CHROMEJun 22, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00226
- DYNASTY® COCR LINERMay 22, 2026InjuryMicroport Orthopedics Inc.3010536692-2026-00198
Event type breakdown
Recalls
4 recall events for this product code
- Wright Medical Technology IncTerminatedAug 12, 2010
DYNASTY A-CLASS POLY LINER, REF DLXP-LD36, 1 EACH, Rx ONLY, STERILE EO, GROUP D, I.D. 36 mm, LIP 15o, LINER STD, Wright Medical Technology, 4677 Airline Road, A
The inner and outer product packaging was missing the following information: shelf life, translations, manufacturing date, CE marking and also listed the incorrect sterilization method.
Z-2212-2010 · View FDA record ↗ - Stryker Howmedica OsteonicsTerminatedJul 20, 2004
Crossfire Acetabular II Insert. Catalog No: 2041C-2642.
This device is not approved for sale in the US.
Z-0560-04 · View FDA record ↗ - Wright Medical Technology IncTerminatedUnknown
CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology
Incorrect packaging, swapped sizes
Z-1715-2009 · View FDA record ↗ - Wright Medical Technology IncTerminatedUnknown
CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length: +3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, Wright Medical Technology
Incorrect packaging, swapped sizes
Z-1716-2009 · View FDA record ↗
Registered firms
236 firms currently registered for this product code
Zimmer, Inc.
WARSAW, IN, US
Sterigenics Us, Llc
Lewis Center, OH, US
Zimmer Biomet Korea Ltd.
Seoul, KR
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Isomedix Operations, Inc.
Libertyville, IL, US
Biomet Mexico
Mexico City Ciudad de Mexico, MX
Biomet Global Supply Chain Center B.v.
Hazeldonk Noord-Brabant, NL
Biomet, Inc.
WARSAW, IN, US
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Shanghai Jpy Ion-tech Co., Ltd.
SHANGHAI, CN
Lh Medical Corporation
Fort Wayne, IN, US
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
Isomedix Operations Inc.
WHIPPANY, NJ, US
510(k) clearances
45 clearances for this product code
- Zimmer, Inc.Aug 7, 2008
K073499 · VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
- WrightmedicaltechnologyincJul 11, 2007
K070785 · DYNASTY ACETABULAR SYSTEM
- WrightmedicaltechnologyincDec 6, 2006
K061844 · DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER
- WrightmedicaltechnologyincAug 22, 2005
K051995 · PROFEMUR RENAISSANCE HIP STEM
- WrightmedicaltechnologyincAug 19, 2005
K051348 · CONSERVE TOTAL FEMORAL HEAD
- Biomet, Inc.Dec 21, 2004
K042841 · M2A/C2A ACETABULAR SYSTEM
- WrightmedicaltechnologyincJul 9, 2004
K041586 · PROFEMUR S HIP STEM
- WrightmedicaltechnologyincMay 28, 2004
K041114 · PROFEMUR TAPERED HIP STEM