Zimmer Biomet, Inc.
FDA adverse event reports naming Zimmer Biomet, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ZIMMER BIOMET, INC..
- Total reports
- 82,548
- Deaths
- 331
- Injuries
- 54,540
- Malfunctions
- 27,677
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH24,023
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH9,589
- Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)KWA7,200
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI6,871
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS3,333
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO3,003
- Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/PolymerMBH2,829
- Shoulder Prosthesis, Reverse ConfigurationPHX2,438
- Orthopedic Manual Surgical InstrumentLXH2,289
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + AdditivePBI1,900
Recent recalls
- 2020-01-29TerminatedUnder Investigation by firm
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
- 2018-09-13TerminatedUnder Investigation by firm
Affixus Hip Fracture Nail Right 125 9 mm x 280 mm, Item Number: 814309280
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-13TerminatedUnder Investigation by firm
Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number: 814309180
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-13TerminatedUnder Investigation by firm
Affixus Hip Fracture Nail Right 125 9 mm x 300 mm, Item Number 814309300
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-13TerminatedUnder Investigation by firm
Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number: 814309320
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-13TerminatedUnder Investigation by firm
Affixus Hip Fracture Nail Right 125 9 mm x 360 mm, Item Number: 814309360
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-13TerminatedUnder Investigation by firm
Affixus Hip Fracture Nail Right 125 9 mm x 380 mm, Item Number: 814309380
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-13TerminatedUnder Investigation by firm
Affixus Hip Fracture Nail Right 125 9 mm x 420 mm, Item Number: 814309420
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-13TerminatedUnder Investigation by firm
Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number: 814309440
The set screw is not able to advance or reverse from the original position in the nail.
- 2018-09-13TerminatedUnder Investigation by firm
Affixus Hip Fracture Nail Right 125 9 mm x 460 mm, Item Number: 814309460
The set screw is not able to advance or reverse from the original position in the nail.
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