OXINIUM 71343608Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 03596010477293), received between Feb 23, 2018 and Feb 24, 2026 — classified as 32 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (14 reports).

4 other recalls cover devices cleared under the same FDA submission (K022958, K024340, K030766, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A THR, WHEN OPENING THE PACKAGE OF A OXINIUM FEM HD 12/14 36 MM L/+8, IT WAS FOUND THE INNER POUCH HAD BEEN BROKEN AND DEFORMED. THE PIECE HAD BEEN ATTACHED TO THE LID. THE PROCEDURE WAS RESUMED, AFTER A 90-MINUTE DELAY, USING A DIFFERENT SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431285 ↗
• InjuryAug 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER RIGHT THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY AN UNSUCCESSFUL MANUAL REDUCTION ON AN UNKNOWN DATE; THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO ADDRESS THE ONGOING ISSUE, IN WHICH THE OXINIUM FEM HD 12/14 36 MM L/+8 WAS EXCHANGED. AN OR3O SYSTEM AND AN R3 SHELL WERE IMPLANTED AS PART OF THIS PROCEDURE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 22906119 ↗
• InjuryMay 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 WEEKS AFTER HAVING A FIRST REVISION SURGERY OF THE LEFT HIP, ON (B)(6) 2017, THE PATIENT EXPERIENCED A PERIPROSTHETIC INFECTION AND NEEDED A SECOND REVISION SURGERY ON (B)(6) 2017. DURING THE REVISION, A WASHOUT WAS PERFORMED ALONG WITH EXCHANGE OF THE HEAD/LINER AND CUP. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 19399050 ↗
• InjuryOct 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT THR PROCEDURE, PERFORMED ON (B)(6) 2014, A REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2015 DUE TO SUBLUXATION OF THE HIP. THE R3 LINER COMPONENT AND OXONIUM 36MM +8 FEMORAL HEAD WERE EXPLANTED, AND A R3 CONSTRAINED LINER WAS USED TO TREAT THE EVENT. WHEN ROM WAS PERFORMED, NO SUBLUXATION OR DISLOCATION OCCURRED. THE PATIENT WAS TAKEN TO RECOVERY IN STABLE CONDITION.

  Patient problems: Subluxation

  MAUDE report 17939438 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON A POST-MARKET CLINICAL FOLLOW-UP ACTIVITY FOR CPCS HIP SYSTEMS, IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT REVISION THR ON (B)(6) 2021 DUE TO LOOSE THA (NON-SMITH+NEPHEW INITIAL IMPLANTS) , ONE (1) PATIENT SUFFERED RIGHT HIP DISLOCATION ON (B)(6) 2021 WHILE DRESSING. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A CLOSED REDUCTION. THIS WAS THE SECOND POST-OPERATIVE DISLOCATION (FIRST DISLOCATION DOCUMENTED UNDER (B)(4)). AT LAST FOLLOW-UP CONDUCTED ON (B)(6) 2021, THE PATIENT WAS DOING WELL AND PRESENTED NO OTHER DISLOCATIONS OR ISSUES AT THAT TIME. THE PATIENT WAS DIAGNOSED WITH LUNG MASS AND DECEASED ON (B)(6) 2021.

  Patient problems: Joint Dislocation

  MAUDE report 16325445 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON A POST-MARKET CLINICAL FOLLOW-UP ACTIVITY FOR CPCS HIP SYSTEMS, IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT REVISION THR ON (B)(6) 2021 DUE TO LOOSE THA (NON-SMITH+NEPHEW INITIAL IMPLANTS), ONE (1) PATIENT EXPERIENCED A FALL AT HOME ON (B)(6) 2021 THAT LED TO RIGHT HIP DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A CLOSED REDUCTION WITH TRACTION. THE PATIENT PRESENTED A SECOND DISLOCATION THAT WAS SOLVED THE SAME WAY (REPORTED UNDER CASE (B)(4)).

  Patient problems: Joint Dislocation

  MAUDE report 16325391 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY PERFORMED ON (B)(6) 2021 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A HEAD/SOCKET MISMATCH THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2022. DURING THIS PROCEDURE, THE FEMORAL HEAD AND LINER WERE EXPLANTED. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT A PRIMARY THR SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM STEM WITH AN R3 ACETABULAR CUP AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16291537 ↗
• InjuryDec 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6)2022, IN WHICH A R3 0 DEG XLPE ACET LNR 36MM X 54MM AND A OXINIUM FEM HD 12/14 36 MM L/+8 WERE EXCHANGED. PATIENT HAS BEEN DISCHARGED FROM HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 16048725 ↗
• InjuryJul 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PLAINTIFF SUFFERED FROM A RIGHT HIP DISLOCATION AND REQUIRED A CLOSED REDUCTION UNDER MODERATE SEDATION ON (B)(6) 2022. X-RAY DEMONSTRATED THAT THE FEMUR WAS DISPLACED SUPERIOR AND LATERAL TO THE ACETABULAR CUP. THE PATIENT TOLERATED THE PROCEDURE WELL. THIS PATIENT HAS A HISTORY OF A PRIMARY RIGHT HIP R3-THA SURGERY ON (B)(6) 2017 AND A SUBSEQUENT REVISION SURGERY ON (B)(6) 2021.

  Patient problems: Joint Dislocation

  MAUDE report 15136398 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN UNKNOWN PRIMARY SURGERY, ONE OXINIUM FEM HD 12/14 36 MM L/+8 AND ONE R3 20 DEG XLPE ACET LNR 36MM X 54MM WERE EXCHANGED DUE TO INFECTION. THE PATIENT REQUIRED A WASHOUT, WHERE THE IMPLANTS WERE EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12569621 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) LEGAL, IT WAS REPORTED THAT, AFTER A FIRST REVISION SURGERY OF THE RIGHT THA PERFORMED ON (B)(6) 2015, WERE THE LINER AND FEMORAL HEAD WERE EXCHANGED, THE PLAINTIFF EXPERIENCED A FIRST HIP DISLOCATION ON (B)(6) 2016 TREATED WITH PAIN MEDICATION, AND A SECOND HIP DISLOCATION ON (B)(6) 2016. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO TREAT THIS ADVERSE EVENT. DURING THE SURGERY THE CUP WAS REINFORCED WITH A 20MM LONG SCREW AND THE FEMORAL HEAD AND LINER WERE EXPLANTED AND EXCHANGED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12516606 ↗
• InjuryAug 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED AN INFECTION. AFTER A LONG-TERM MANAGEMENT WITH ANTIBIOTICS, THE HIP WAS WASHED OUT AND REVISED ON (B)(6) 2021. THE LINER (UNKNOWN MANUFACTURER) WAS EXPLANTED, AS WELL AS THE FEMORAL HEAD (SN DEVICE). PREVIOUSLY, ON (B)(6) 2021, THE PATIENT HAD A PREVIOUS WASHOUT AND REVISION WITH HEAD/LINER EXCHANGE IN THE SAME HIP ALSO DUE TO INFECTION, HOWEVER, THE ORIGIN OF THE EXPLANTS WAS NOT REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 12320515 ↗
• InjuryMay 11, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, AFTER A RECON SURGERY HAD BEEN PERFORMED, X-RAY APPEARED THAT THE OXINIUM FEM HD 12/14 36 MM L/+8 WASN¿T PROPERLY ENGAGING THE TRUNNION OF THE POLARSTEM IMPLANT. THE ADVERSE EVENT WAS ADDRESSED WITH A REVISION SURGERY TO REPLACE THE HEAD. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 11809693 ↗
• InjuryFeb 19, 2021Inadequacy of Device Shape and/or Size; Scratched Material; Inadequacy of Device Shape and/or Size; Scratched Material

  IT WAS REPORTED THAT A OXINIUM FEM HD +8 WAS EXCHANGED DUE TO DOCTOR'S OPINION (UNHAPPY WITH THE LEG LENGTH, VERIFIED VIA X-RAYS) THEREFORE, +8 SIZE WAS CHANGED TO A +4 HEAD. NO SURGICAL DELAY WERE REPORTED. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347743 ↗
• InjuryOct 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENTS LEFT HIP DUE TO AN INFECTION. ONLY THE HEAD AND LINER WERE REMOVED. THE LINER WAS FROM STRYKER. THE PATIENT'S OUTCOME IS UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10730562 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A HIP REPLACEMENT, THE PATIENT APPEARED TO HAVE A POSSIBLE INFECTION. A REVISION SURGERY WAS PERFORMED TO WASH OUT THE JOINT AND EXCHANGE THE OXINIUM FEMORAL HEAD 12/14 36 MM L/+8. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10428848 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASHOUT OF HIP AND EXCHANGE XLPE LINER AND OXINIUM HEAD DUE TO INFECTION. PRIMARY HIP REPLACEMENT DATE: (B)(6) 2020. NO REPORT REQUESTED BY SURGEON. 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 10258205 ↗
• InjuryApr 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO RECURRENT DISLOCATION. ON (B)(6) OF 2010, THE PATIENT HAD A RIGHT HIP DISLOCATION - WITH 45 DEGREES OF INTERNAL ROTATION, THE HIP DISLOCATED AT 90 DEGREES OF FLEXION. THE PATIENT UNDERWENT A CLOSED REDUCTION PROCEDURE. ON (B)(6) OF 2010, THE PATIENT HAD REVISION SURGERY DUE TO THE RIGHT HIP BEING UNSTABLE AND DISLOCATED.

  Patient problems: Injury

  MAUDE report 9936344 ↗
• InjuryApr 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT SUFFERING FROM RECURRENT RIGHT HIP DISLOCATIONS. THE PATIENT HAD A HISTORY OF MULTIPLE DISLOCATIONS PREVIOUS TO THIS ONSET OF EVENTS.

  Patient problems: Injury

  MAUDE report 9928563 ↗
• InjuryApr 3, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT HAD FLUID BUILDING UP UNDER HIS CLOSED HIP WOUND, FOLLOWING A THR. ADDITIONALLY, THE PATIENT REPORTED A FEELING OF SMALL LAXITY IN HIS SOFT TISSUES. THE EVENT WAS RESOLVED VIA REVISION SURGERY, WHERE THE OXINIUM HEAD WAS CHANGED FROM A +8 TO A +12.

  Patient problems: Injury

  MAUDE report 9919463 ↗
• InjurySep 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION.

  Patient problems: Injury

  MAUDE report 9101204 ↗
• InjuryAug 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO RECURRENT DISLOCATIONS.

  Patient problems: Joint Dislocation

  MAUDE report 8849252 ↗
• InjuryMay 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. CUP, LINER AND HEAD WERE REPLACED. THE SURGEON DOES NOT BLAME THE DEVICES.

  Patient problems: Injury

  MAUDE report 8597358 ↗
• InjuryApr 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. HEAD AND LINER WERE REPLACED. NO MORE INFORMATION PRESENTED.

  Patient problems: Injury

  MAUDE report 8512566 ↗
• InjuryApr 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION.

  Patient problems: Injury

  MAUDE report 8471451 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022958, K024340, K030766, 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
• Z-0389-2010 · Jan 23, 2009 · Terminated
  Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116
• Z-2314-2009 · Jan 12, 2009 · Terminated
  Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems and acetabular components distributed by Smith & Nephew.