OXINIUM 71342812Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010474186), received between Feb 15, 2019 and Feb 24, 2021 — classified as 3 injuries.

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

2 other recalls cover devices cleared under the same FDA submission (K021673, K211176); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION OF A TOTAL RIGHT HIP WAS PERFORMED. A SMITH & NEPHEW UNIPOLAR HEAD AND INSERT WERE EXPLANTED. SMITH & NEPHEW SYNERGY FEMORAL STEM AND BHR CUP REMAINED IN PLACE.

  Patient problems: Failure of Implant

  MAUDE report 11371684 ↗
• InjuryOct 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A REVISION SURGERY THE 28MM + 12 HEAD WAS REPLACED WITH AN OXINIUM 28MM +16 HEAD, BECAUSE THE PATIENT WAS VERY UNSTABLE AND DISLOCATED. BACK-UP DEVICE AVAILABLE, NO DELAY REPORTED.

  Patient problems: Injury

  MAUDE report 9187403 ↗
• InjuryFeb 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH AN X-RAY IMAGE THAT THE PATIENT PRESENTED A DISLOCATION OF THE IMPLANT'S FEMORAL HEAD. IT IS UNKNOWN THE DATE OR SIDE OF DISLOCATION. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PERFORMED TO CORRECT THE ADVERSE EVENT. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8345226 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021673, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
• Z-1901-2024 · Apr 24, 2024 · Open, Classified
  smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4