OXINIUM 71342204Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010488879), received between Aug 11, 2017 and Jun 25, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2025Corroded; Device Dislodged or Dislocated; Corroded; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY, WITH DUAL MOBILITY (OR3O) IMPLANTS, WAS PERFORMED ON (B)(6) 2025, THE PATIENT CAME BACK FOR FOLLOW UP WITH A HEAD DISLOCATION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2025 IN WHICH THE OXINIUM FEM HD 12/14 22 MM +4 AND THE OR3O DM XLPE INSERT 22/38 WERE EXCHANGED. ALSO, WHEN OPENING THE WOUND IT WAS FOUND THAT THERE WAS CORROSION ON THE OXINIUM FEM HD 12/14 22 MM +4. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 22328652 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED IN 2006 AND REVISED IN 2017, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2023, IN WHICH CONSTRAINED LINER AND HEAD WAS REMOVED, WASHOUT AND DEBRIDEMENT TOOK PLACE AND A NEW CONSTRAINED LINER AND HEAD WAS PUT IN. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17585058 ↗
• InjuryMay 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, A REVISION SURGERY FOR THE R3 3 HOLE ACET SHELL 52MM HAD TO BE PERFORMED ON (B)(6) 2021. THE CLINICAL OUTCOME OF THE PATIENT WAS REPORTED AS "RECOVERED".

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 16883068 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON (B)(6) 2022, THE OXINIUM FEMORAL HEAD 12/14 22 MM +4 DISSOCIATED FROM THE R3 CONSTRAINED LINER 58MM. THIS EVENT WAS ADDRESSED VIA REVISION SURGERY TO EXCHANGE FOR COMPETITOR DEVICES. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15194568 ↗
• InjuryApr 19, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A DISLOCATION AFTER BECOMING INTOXICATED AND FALLING. IT WAS TRIED TO SOLVE BY A CLOSE REDUCTION TO PLACE HEAD/INSERT CONSTRUCT BACK INTO SHELL. DURING REDUCTION THE HEAD/INSERT WAS DIFFICULT TO REDUCE AND ULTIMATELY THE 22MM HEAD DISSOCIATED FROM THE XLPE INSERT. A REVISION SURGERY WILL BE PERFORMED ON AN UNSPECIFIED DATE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 14148470 ↗
• InjuryDec 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED. AND A CLOSED REDUCTION WAS PERFORMED AND FAILED. REVISION SURGERY WAS PERFORMED AND IMPLANTS OF THE SAME SIZE WERE IMPLANTED. NO PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 11069166 ↗
• InjuryJun 18, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT, AFTER A OR3O SYSTEM HAD BEEN IMPLANTED IN A THR SURGERY, THE PATIENT PRESENTED A DISLOCATED DUAL MOBILITY PROSTHESIS. A CLOSED REDUCTION WAS PERFORMED TO ALLEVIATE THE PROBLEM; HOWEVER, UPON OBTAINING X-RAYS, ECCENTRICITIES WERE DISCOVERED BETWEEN THE SHELL AND THE FEMORAL NECK ON THE STEM, WHICH WAS ALSO CONFIRMED WITH A CT SCAN, SO THE PATIENT WAS SCHEDULED FOR REVISION SURGERY THE NEXT DAY. DURING THE REVISION SURGERY, THE SHELL WAS FOUND TO BE WELL FIXED. THE STEM WAS ALSO WELL FIXED WITH THE FEMORAL HEAD STILL ATTACHED TO THE MORSE TAPER. THE DUAL MOBILITY PLASTIC BEARING WAS DETACHED FROM THE FEMORAL HEAD AND WAS NOT INSIDE THE DUAL MOBILITY LINER. THE SURGEON (I) REMOVED BOTH THE CUP AND CEMENTED STEM AND PLACED A 4MM LARGER R3 CUP (54MM) IN A MORE ANTEVERTED POSITION; (II) DOWNSIZED THE STEM WHILE CONVERTING TO A HIGH OFFSET IMPLANT, PLACING IT IN A MORE SUPERIOR POSITION; AND (III) CHOSE TO USE AGAIN AN OR3O DUAL MOBILITY IMPLANT WITH THIS CONSTRUCT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 10171684 ↗
• InjuryMay 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Injury

  MAUDE report 8624637 ↗
• InjuryFeb 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO A DISLOCATION. NO ADDITIONAL INFORMATION SPECIFIED.

  Patient problems: Injury

  MAUDE report 8299088 ↗
• InjuryJun 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO HIP DISLOCATION WITH BLOODLESS REDUCTION.

  Patient problems: Joint Dislocation

  MAUDE report 7649432 ↗
• InjuryJun 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO HIP DISLOCATION, FOLLOWED BY BLOODLESS REDUCTION.

  Patient problems: Joint Dislocation

  MAUDE report 7649427 ↗
• InjuryMay 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Joint Dislocation

  MAUDE report 7484526 ↗
• InjuryAug 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A HIP REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE HEAD AND LINER WERE REPLACED DURING THE SURGERY. THE SURGEON STATED THE PATIENT WAS NON-COMPLIANT WITH THE POST-OP RECOVERY PLAN.

  Patient problems: Joint Dislocation

  MAUDE report 6788985 ↗

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