NA 802804004Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887868376702), received between Mar 23, 2022 and Feb 13, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K181171, K200823); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2023Off-Label Use; Off-Label Use

  IT WAS REPORTED THE PATIENT HAD POST-OP PERIPROSTHETIC FRACTURE OF FEMUR REQUIRING REVISION APPROXIMATELY 12 (TWELVE) DAYS AFTER INITIAL SURGERY. THIS REVISION WAS NOT DUE TO A FALL. IT IS NOTED THAT THE HEAD IS NOT COMPATIBLE WITH THE STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 16362269 ↗
• InjuryMar 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED PATIENT UNDERWENT INITIAL HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 4 MONTHS POST IMPLANTATION DUE TO REOCCURRING DISLOCATIONS. THE HEAD AND LINER WERE REVISED AS WELL AS THE CUP TO ADD ANTEVERSION.ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13870546 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181171, K200823. One submission often covers many models, so check the product and lot details in each record.

• Z-1648-2025 · Mar 24, 2025 · Open, Classified
  Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
• Z-1646-2025 · Mar 24, 2025 · Open, Classified
  Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncem
• Z-1647-2025 · Mar 24, 2025 · Open, Classified
  Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
• Z-1649-2025 · Mar 24, 2025 · Open, Classified
  Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
• Z-1645-2025 · Mar 24, 2025 · Open, Classified
  Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncem
• Z-2519-2023 · Jul 26, 2023 · Open, Classified
  M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)