KWBClass IIIImplant
Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
Orthopedic · 21 CFR 888.3370
Call for PMAs 12/26/96 (61 FR 50710 (9/27/96))
MDR events6,780All time
Recalls0All time
Registered firms9Currently listed
510(k) clearances0All time
Recent MDR events
6,780 adverse event reports on file
- COLLECT.NO.QAS HIP STEMS MISC./UNKNOWNApr 25, 2024InjuryAesculap Ag9610612-2024-00132
- COLLECT.NO.QAS HIP STEMS MISC./UNKNOWNApr 25, 2024InjuryAesculap Ag9610612-2024-00131
- COLLECT.NO.QAS HIP STEMS MISC./UNKNOWNApr 23, 2024InjuryAesculap Ag9610612-2024-00133
- COLLECT.NO.QAS ACETAB.CUPS MISC./UNKNOWNApr 23, 2024InjuryAesculap Ag9610612-2024-00128
- BIPOLAR CUP ID26MM OD49MM SELF-CENTERINGOct 12, 2022InjuryAesculap Ag9610612-2022-00300
- UNK COTILE SCREWSep 12, 2022InjuryZimmer Biomet, Inc.0001822565-2022-02625
- UNK COTILE SCREWSep 12, 2022InjuryZimmer Biomet, Inc.0001822565-2022-02622
- ALLOFIT IT ALLOCLASSIC ACETABULAR SHELL 48/GGAug 25, 2022MalfunctionZimmer Switzerland Manufacturing Gmbh0009613350-2022-00433
- DURASUL, ALPHA INSERT, II/36Apr 20, 2022InjuryZimmer Switzerland Manufacturing Gmbh0009613350-2022-00249
- DURASUL, ALPHA INSERT, NN/36Dec 9, 2021InjuryZimmer Switzerland Manufacturing Gmbh0009613350-2021-00660
Event type breakdown
Injury6,057
Malfunction464
Other213
Unspecified38
Death8
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
9 firms currently registered for this product code
Biomet Chile S.a.
Santiago de Chile Region Metropolitana, CL
Zimmer Biomet G.k.
Hiratsuka Kanagawa, JP
Isomedix Operations, Inc.
Libertyville, IL, US
Aps Materials, Inc.
DAYTON, OH, US
Biomet, Inc.
WARSAW, IN, US
Zimmer Biomet Taiwan Co., Ltd.
Taipei, TW
Zimmer (shanghai) Medical International Trading Co., Ltd.
Shanghai, CN
Zimmer Biomet Korea Ltd.
Seoul, KR
Zimmer Biomet Pty Ltd
Sydney New South Wales, AU
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.