OXINIUM 71342600Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010488893), received between May 17, 2018 and Sep 9, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) OXINIUM FEM HD 12/14 26 MM +0 AND ONE (1) TNDM BP SHL/XLPE LNR 42OD 26ID WERE EXPLANTED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Medical device site infection

  MAUDE report 23004323 ↗
• InjuryMar 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED DISLOCATION. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY TO EXCHANGE THE OXINIUM FEM HD 12/14 26 MM +0, WITH COMPETITOR PRODUCTS. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 13635967 ↗
• InjuryJan 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION, THE FOLLOWING DEVICES WERE REMOVED: OXINIUM FEMORAL HEAD 12/14 26 MM, ANTHOLOGY STANDARD OFFSET POROUS PLUS HA STEM SIZE 5 AND TNDM BP SHL/XLPE LNR 46OD 26ID. THE PROCEDURE WAS COMPLETED USING A SMITH & NEPHEW BACK-UP DEVICE. IT IS UNKNOWN IF A SURGICAL DELAY HAPPENED. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Dislocation

  MAUDE report 11126052 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. NO MORE INFORMATION WAS INITIALLY PROVIDED.

  Patient problems: Failure of Implant; Injury; Joint Dislocation

  MAUDE report 10745216 ↗
• InjurySep 29, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD IMPLANTED SMITH AND NEPHEW DEVICES. THE PATIENT WAS EXPERIENCED INFECTION AND FEVER. REVISION SURGERY IS PLANNED TO RESOLVE THIS ISSUE ON (B)(6) 2020. THE DOCTOR SAYS THE DEVICES ARE NOT DEFECTIVE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 10604080 ↗
• InjuryMay 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY WAS PERFORMED DUE TO FREQUENT DISLOCATION. THE PATIENT HAD ACETABULAR DYSPLASIA. THE SURGEON THOUGHT THIS REVISION WAS NOT A PRODUCT FAILURE. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 7522489 ↗

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