OXINIUM 71342808Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03596010474179), received between Dec 21, 2017 and May 8, 2024 — classified as 15 injuries.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 8 WEEKS AFTER A RIGHT HIP REVISION WAS PERFORMED, THE PATIENT DEVELOPED INCREASING PAIN, DRAINAGE, AND AN ERYTHEMA AROUND THE WOUND. HIS HIP WAS ASPIRATED, AND THE CULTURE GREW PSEUDOMONAS. THE PATIENT UNDERWENT A SECOND REVISION SURGERY ON (B)(6) 2021 TO TREAT THE RIGHT PERIPROSTHETIC JOINT INFECTION. DURING THE REVISION, THE DUAL MOBILITY INSERT AND THE OXINIUM FEMORAL HEAD WERE EXPLANTED AND REPLACED. THE PATIENT WOKE UP FROM THE PROCEDURE AND WAS TRANSFERRED TO PACU IN STABLE CONDITION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Erythema; Medical device site infection; Pain

  MAUDE report 19271047 ↗
• InjuryFeb 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT THR REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2019 WITH LOOSENING OF THE STEM AS PRIMARY DIAGNOSIS, THE PATIENT EXPERIENCED A DISLOCATION/SUBLUXATION WITH MALALIGNMENT OF THE SOCKET THAT MADE NECESSARY A SECOND REVISION SURGERY ON (B)(6) 2019. ACCORDING TO THE REPORT CONTENTS, THE FEMORAL STEM, HEAD AND ACETABULAR LINER WERE EXPLANTED AND REPLACED WITH COMPETITORS 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 FIRST THR REVISION SURGERY WITH A HIP PROSTHESIS CONSTRUCT THAT INCLUDED A POLARSTEM FEMORAL PROSTHESIS AND THAT REQUIRED A SECOND REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 16285088 ↗
• InjuryNov 15, 2022Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A RIGHT THR INDEX SURGERY PERFORMED ON (B)(6) 2016 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2016. DURING THIS PROCEDURE, THE FEMORAL HEAD WAS EXPLANTED AND REPLACED WITH SMITH AND NEPHEW COMPONENT. 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 THAT REQUIRED A REVISION SURGERY DUE TO SPECIFIC REASONS. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Foreign Body Reaction

  MAUDE report 15801678 ↗
• 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 (B)(6) 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 15733679 ↗
• InjuryJun 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A REVISION SURGERY CONDUCTED ON THE PATIENT'S RIGHT HIP ON (B)(6) 2019, THE PATIENT EXPERIENCED A DISLOCATION ON (B)(6) 2019 AND REQUIRED AN ADDITIONAL REVISION SURGERY ON (B)(6) 2019 TO SOLVE THIS ADVERSE EVENT. THE CONTRIBUTION OF THE OXINIUM FEM HD 12/14 28MM +8 TO THE REPORTED DISLOCATION CANNOT BE DISCARDED AT THIS TIME. THE IDENTITY OF THE EXPLANTED DEVICES AND THE ONES IMPLANTED IN EXCHANGE IS UNKNOWN AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 14670346 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON A THR SURGERY PERFORMED ON THE (B)(6) 2021, THE OXINIUM FEM HD 12/14 28MM +8 WAS IMPACTED ON WITH THE OR3O IMPACTOR THAT COMES IN THE TRAY. THE SURGEON CHECKED TO MAKE SURE IT WAS ON THE STEM AND THE TRIALING WAS VERY STABLE. HE WAS HAPPY WITH THE CUP PLACEMENT. HE WAS VERY HAPPY WITH THE POST OPERATIVE X-RAY UNTIL HE SAW THE FILMS THE NEXT DAY, IN WHICH IT APPEARS THAT THE PATIENT DISLOCATED SINCE THE OXINIUM FEM HD 12/14 28MM +8 DETACHED FROM THE POLARSTEM COLLAR STD. TI/HA 4. ONE DETAIL TO NOTE WAS THAT THE OXINIUM HEAD AND THE OR3O DM XLPE INSERT 28/42 APPEARED TO BE MOVING TOGETHER WHILE TRIALING, BUT NOT ENOUGH TO SOUND ANY ALARMS AT THE TIME. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2021 AND THE OR3O IMPLANTS WERE REMOVED AND THE SYSTEM WAS CONVERTED TO A STANDARD HEAD AND POLY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: Joint Dislocation

  MAUDE report 13211380 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2021, A REVISION SURGERY HAD TO BE CONDUCTED ON (B)(6) 2021 DUE TO PAIN. AN OXINIUM FEM HD 12/14 28MM +8 WAS EXPLANTED. SURGEON STATES THAT THE DEVICES WERE NOT DEFECTIVE OR LOOSE. CURRENT PATIENT STATUS REMAINS UNKNOWN.

  Patient problems: Pain

  MAUDE report 12753876 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT EXPERIENCED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 WHERE R3 20 DEG XLPE ACET LNR 28MM X 46MM AND OXINIUM FEM HD 12/14 28MM +8 WERE EXPLANTED. PATIENTS CURRENT HEALTH STATUS IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY FOR ENGLAND, WALES, NORTHERN IRELAND AND THE ISLE OF MAN SUPPLIER FEEDBACK; THEREFORE, FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 12242265 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A THIRD MEDICALLY INDICATED TWO-STAGE REVISION ON (B)(6) 2020 DUE TO INFECTION. ALL THE COMPONENTS WERE REMOVED, AND AN ANTIBIOTIC SPACER WAS PLACED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 11573378 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT THE PLAINTIFF UNDERWENT A SECOND MEDICALLY INDICATED REVISION ON (B)(6) 2020 DUE TO INFECTION. AN IRRIGATION, DEBRIDEMENT AND POLY (STRYKER) EXCHANGE WAS PERFORMED. A NEW S&N HEAD WAS IMPLANTED ALONGSIDE COMPETITOR DEVICES. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 11573374 ↗
• InjuryFeb 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE REVISION SURGERY, ANOTHER MEDICAL INTERVENTION UNDER ANESTHESIA (CLOSED REPOSITION) WAS PERFORMED DUE TO A LUXATION. THE PATIENT OUTCOME WAS POSITIVE.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 11390950 ↗
• InjuryFeb 15, 2021Device Appears to Trigger Rejection; Naturally Worn; Device Appears to Trigger Rejection; Naturally Worn

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED, THE PATIENT EXPERIENCED METALLOSIS. A REVISION SURGERY WAS PERFORMED TO REVISE THE WORN OXINIUM FEM HD 12/14 28MM +8 AND AN UNSPECIFIED LINER. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 11326438 ↗
• InjuryApr 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD RIGHT HIP PROSTHESIS INFECTION AFTER SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 8530139 ↗
• InjuryJul 18, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE PATIENT HAD SUBLUXED A NUMBER OF TIMES FOLLOWING SURGERY 3 MONTHS AGO AND DISLOCATED FOR THE FIRST TIME WHEN TRANSFERRING ONTO SURGICAL TABLE YESTERDAY. DOCTOR OPENED THE HIP JOINT USING THE PREVIOUS INCISION. THE HEAD AND LINER WERE REMOVED AND A 20 DEGREE TRIAL LINER USED TO ASSESS STABILITY. SURGEON STILL THOUGHT THE JOINT WAS NOT SUFFICIENTLY STABLE SO PROGRESSED TO REMOVING THE CUP WITH EXPLANT.

  Patient problems: Injury

  MAUDE report 7697383 ↗
• InjuryDec 21, 2017Metal Shedding Debris; Metal Shedding Debris

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO USURY AND LOOSING OF METAL RESTS. THE SURGEON REPLACED THE IMPLANT WITH A LONGER OXINIUM HEAD.

  Patient problems: Failure of Implant; Injury

  MAUDE report 7138075 ↗

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.