NA 802202203Recalls & reported problems
Zimmer, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024498761), received between Oct 3, 2022 and Feb 25, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
- Joint Dislocation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP ARTHROPLASTY AND WAS IMPLANTED WITH ZIMMER BIOMET PRODUCTS. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO DISLOCATION. THE BEARING AND HEAD WERE EXPLANTED. THE PATIENT WAS REVISED A SECOND TIME DUE TO THE BEARING AND HEAD DISASSOCIATING AFTER DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 21460317 ↗InjuryOct 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION APPROXIMATELY 7 MONTHS POST IMPLANTATION DUE TO DISLOCATION. DURING THE PROCEDURE, IT WAS FOUND THAT THE METAL HEAD HAD POPPED OUT OF THE DUAL MOBILITY HEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Patient problems: Failure of Implant
MAUDE report 15529337 ↗
Other Prosthesis, hip, constrained, cemented or uncemented, metal/polymer devices
- Novation 134-36-45Exactech, Inc. · Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer2 recalls0 reports
- PINNACLE 1218-28-650Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer89 reports
- Trident 690-00-28FHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall37 reports
- Trident 690-00-22EHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall36 reports
- PINNACLE 1218-32-652Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer75 reports
- Trident 690-00-22DHowmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall22 reports
- PINNACLE 1218-32-654Depuy Orthopaedics, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer70 reports
- Trident 69-2850Howmedica Osteonics Corp. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer1 recall11 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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