OXINIUM 71343208Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 03596010474230), received between Jul 25, 2017 and May 11, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 reports).

4 other recalls cover devices cleared under the same FDA submission (K021673, 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. 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED AN ISSUE WITH THE LENGTH OF HER LEG, THIS WAS CHECKED WITH SOME POST OP X RAYS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) OXINIUM FEM HD 12/14 32MM +8 WAS REPLACED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unequal Limb Length

  MAUDE report 25145360 ↗
• InjuryDec 23, 2025Adverse 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 ON (B)(6) 2025, THE PATIENT EXPERIENCED AN LUXATION. THE ADVERSE EVENT WAS ADDRESSED THROUGH A REVISION SURGERY ON (B)(6) 2025. THE PATIENT¿S CURRENT HEALTH STATUS IS STABLE.

  Patient problems: Joint Dislocation

  MAUDE report 23876759 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING A THR REVISION SURGERY ON (B)(6) 2023 DUE TO A BROKEN TOTAL HIP ARTHROPLASTY ALONG WITH SEVERE METALLOSIS, THE PATIENT SUFFERED FROM DISLOCATION OF LEFT HIP ARTHROPLASTY. THIS ADVERSE EVENT WAS ADDRESSED BY DOING A CLOSED REDUCTION ON (B)(6) 2023, DURING WHICH, UNDER GENERAL ANESTHESIA, THE HIP WAS EXAMINED. THE HIP WAS SLIGHTLY SHORTENED AND EXTERNALLY ROTATED. SLIGHTLY FLEXION WAS DONE, DISTAL TRACTION APPLIED, AND IT WAS INTERNALLY ROTATED AND THE HIP REDUCED. AT THIS POINT, IT WAS STABLE AFTER REDUCTION. THERE WERE NO COMPLICATIONS.

  Patient problems: Joint Dislocation

  MAUDE report 23622106 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR THAT TOOK PLACE AT AN UNKNOWN DATE, BOTH THE OXINIUM FEM HD 12/14 32MM +8 AND AN UNKNOWN LINER HAD TO BE REMOVE ON A REVISION SURGERY THAT TOOK PLACE ON (B)(6) 2025, DUE TO AN UNKNOWN REASON. COMPETITOR'S DEVICES WERE USED AS REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 21730904 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PRIMARY THR WAS PERFORMED ON (B)(6) 2015, PATIENT HAD TO UNDERGO A REVISION OF THE OXONIUM FEM HD (B)(6) 2024 32MM +8 DUE TO SUBSIDENCE AND IMPINGEMENT. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Impingement

  MAUDE report 21410664 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2018 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON 21-MAR-2019. DURING THIS PROCEDURE, THE FEMORAL HEAD AND THE ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH SIMILAR DEVICES. 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 AND AN R3 SHELL AND THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 15739472 ↗
• InjurySep 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER A THR SURGERY PERFORMED ON (B)(6) 2012 WHERE AN OXINIUM FEMORAL HEAD SIZE 32, AN R3 CUP SIZE 56 AND A NANOS STEM SIZE 6 WERE IMPLANTED. ON (B)(6) 2022, PATIENT EXPERIENCED A SUBLUXATION ON THE RIGHT HIP. WHEN OVER LIFTING IN THE AMBULANCE, THERE WAS A HIP REPOSITIONING. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Subluxation

  MAUDE report 15519431 ↗
• InjuryJul 29, 2022Material Erosion; Material Erosion

  IT WAS REPORTED THAT, AFTER A REVISION THR HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO ADDRESS THIS EVENT. DURING EXPOSURE, THE SURGEON NOTICED DARK COLORED FLUID IN THE WOUND WHILE REMOVING THE COMPONENTS ALONG WITH CATASTROPHIC WEAR ON THE OXINIUM HEAD. SURGEON CLEANED THE SITE AND IMPLANTED A 40MM OXINIUM HEAD/SLEEVE WITH APPROPRIATE CUP/LINER. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Infiltration into Tissue; Joint Laxity; Metal Related Pathology

  MAUDE report 15136638 ↗
• InjuryFeb 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2021, THE PATIENT EXPERIENCED RECURRENT DISLOCATION IN THE JOINT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REVISED AN OXINIUM FEM HD 12/14 32MM +8 TO CORRECT THIS ISSUE. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13551337 ↗
• InjuryNov 19, 2021Adverse 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 AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A JOINT CAPSULE INFECTION AND THE ECHELON HA STD 260 BOW S 12 L WAS BROKEN. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE REF NO HOLE SHELL SZ 52MM, ECHELON HA STD 260 BOW S 12 L, OXINIUM FEM HD 12/14 32MM +8 AND AN UNKNOWN REFLECTION LINER WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Failure of Implant; Unspecified Infection

  MAUDE report 12846685 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED THREE HIP DISLOCATIONS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THE SURGERY THE FEMORAL HEAD AND THE LINER WERE EXCHANGED AS PLANNED TO ACHIEVE STABILITY THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12111822 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY, THERE WERE HIGH LEVELS OF METALS FOUND IN THE BLOOD OF THE PATIENT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS EVENT. THE SL-PLUS STEM LATERAL 2 NON-CEMENTED (CASE-(B)(4)) AND THE OXINIUM FEM HD 12/14 32MM +8 (CASE-(B)(4)) WERE EXPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 11902609 ↗
• InjuryApr 25, 2021Adverse 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) 2017, THE PATIENT EXPERIMENTED MULTIPLE DISLOCATIONS RECENTLY. THIS ADVERSE EVENT WAS ADDRESSED THROUGH REVISION SURGERY TO EXCHANGE LINER AND HEAD. GIVEN THAT THE SIZE OF R3 CUP IS 50 MM AND, THEREFORE, NOT ABLE TO TAKE A CONSTRAINED LINER, IT THE R3 CUP WAS ALSO REMOVED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11722118 ↗
• InjuryMar 9, 2020Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO LOOSENING. THE OXINIUM FEMORAL COMPONENT HD 12/14 32MM +8 WAS EXPLANTED. THE PATIENT IS ALSO COMPLAINING ABOUT PAIN AND FEELING STRANGE.

  Patient problems: Injury

  MAUDE report 9806161 ↗
• InjuryDec 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD SMITH&NEPHEW PRODUCTS IN PLACE SINCE (B)(6) 2013 AND WAS FEELING UNCOMFORTABLE AND LOOSENING OF THE CUP. REVISION SURGERY WAS PERFORMED AND THE CUP AND INNER HEAD WERE EXPLANTED.

  Patient problems: Injury

  MAUDE report 9528903 ↗
• InjuryJun 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Injury

  MAUDE report 8738104 ↗
• InjuryOct 29, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON REVISION THE CUP WAS FOUND TO BE MISALIGNED. NO DELAY, INJURY OR BACK REPORTED.

  Patient problems: Injury

  MAUDE report 8017280 ↗
• InjuryJun 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING AND DISLOCATION OF THE CUP. THE ACETABULAR SHELL, THE LINER, THE FEMORAL HEAD AND THE HEAD SCREW WERE EXPLANTED.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7610133 ↗
• InjuryMay 9, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PERIPROSTHETIC FRACTURE.

  Patient problems: Injury

  MAUDE report 7500945 ↗
• InjuryDec 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UKNOWN REASONS.

  Patient problems: Injury

  MAUDE report 7140049 ↗
• InjurySep 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. THE SURGEON DECIDED IT IS NOT THE PRODUCT FAILURE BUT IT WAS THE TECHNICAL ERROR (THE CUP POSITION WAS NOT GOOD).

  Patient problems: Injury

  MAUDE report 6858681 ↗
• InjuryJul 25, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT PRESENTED WITH A PREOPERATIVE DIAGNOSIS OF ALIGNMENT DISASSOCIATION OF THE RIGHT HIP. THE PATIENT UNDERWENT A RIGHT HIP REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 6742417 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021673, 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.