OXINIUM 71342608Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010488916), received between Oct 5, 2017 and Sep 12, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Separation” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K021673, K211176, K240783); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2022, WHERE THE OXINIUM FEM HD 12/14 26 MM +8 WAS EXPLANTED AND REPLACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15407807 ↗
• InjuryAug 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 8884442 ↗
• InjuryDec 21, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. LOCKING RING WAS DISASSEMBLED WITH THE BIPOLAR CUP IN VIVO. BIPOLAR CUP AND HEAD WERE REVISED.

  Patient problems: Injury

  MAUDE report 8192739 ↗
• InjurySep 12, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A REVISION SURGERY WILL BE SCHEDULED SINCE THE HEAD OF TANDEM BIPOLAR WAS DISLOCATED.

  Patient problems: Joint Dislocation

  MAUDE report 7869421 ↗
• InjuryOct 5, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6917670 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021673, K211176, K240783. 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