OXINIUM 71342803Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010474155), received between Oct 10, 2018 and Dec 18, 2025 — classified as 13 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); 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.

• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A PERIPROSTHETIC INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2025. THE PATIENT WAS BEING GIVEN IV ANTIBIOTICS FOR TREATMENT OF PERIPROSTHETIC THR INFECTION. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 23838081 ↗
• InjuryFeb 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY PERFORMED ON (B)(6) 2020 TO ADDRESS OSTEOARTHRITIS SYMPTOMS, THE PATIENT SUSTAINED A DISLOCATION/SUBLUXATION THAT MADE NECESSARY A REVISION SURGERY ON (B)(6) 2021. DURING THIS PROCEDURE, THE MODULAR 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: Joint Dislocation; Subluxation

  MAUDE report 16283702 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 DUE TO ACCUMULATING WATER. THE OXINIUM FEM HD 12/14 28MM -3 WAS EXPLANTED. THE SURGEON SAYS IT WAS NOT CAUSED BY INFECTION. NO CAUSATIVE MICROORGANISM (BACTERIA) IS DETECTED. ALSO, THE SURGEON DID NOT THINK S+N DEVICES WERE DEFECTIVE. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.

  Patient problems: Swelling/ Edema

  MAUDE report 13619381 ↗
• InjuryNov 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT AFTER REVISION SURGERY WHERE S+N DEVICES WERE IMPLANTED, AND HIP WAS REVISED TO A THA; PLAINTIFF SUFFER A HIP DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DETAILS ABOUT THE SURGERY INCLUDING THE EXPLANTED AND IMPLANTED DEVICES ARE UNKNOWN. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12779644 ↗
• InjuryNov 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. IT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE OXINIUM FEM HD 12/14 28MM -3 WAS EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12753989 ↗
• InjuryOct 11, 2021Migration; Migration

  *US LEGAL MDL* IT WAS REPORTED THAT A SECOND REVISION SURGERY WAS PERFORMED ON THE PATIENT RIGHT HIP ON (B)(6) 2020. THE SECOND REVISION WAS PERFORMED DUE TO ELEVATED SERUM COBALT AND CHROMIUM LEVELS, METALLOSIS, MECHANICAL FAILURE OF MODULAR DUAL MOBILITY CONSTRUCT, PROXIMAL FEMORAL MIGRATION, LINER WEAR, PAIN, DECREASED MOBILITY AND PSEUDOTUMOR FORMATION. DURING THIS PROCEDURE, THE ACETABULAR CUP, XLPE LINER, AND OXINIUM FEMORAL HEAD WERE EXPLANTED, AND A DEBRIDEMENT OF METALLOSIS AND ALLOGRAFT AUGMENTATION ON THE ACETABULUM WERE CONDUCTED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM, EXTUBATED AND IN STABLE CONDITION.

  Patient problems: Failure of Implant; Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 12603065 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN UNKNOWN SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT PRESENT INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12211700 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED UNKNOWN SYMPTOMS WHICH LED TO A REVISION SURGERY. THIS REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS EVENT AND THE FOLLOWING IMPLANTS WERE EXPLANTED FROM PATIENT: R3 0 DEG XLPE ACET LNR 28 MM X 48 MM AND OXONIUM FEM HD 12/14 28 MM -3. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886774 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIMARY PROCEDURE WAS PERFORMED ON (B)(6) 2015. PATIENT DISLOCATED 2 MONTHS AGO AND THE HIP WAS RELOCATED BUT THREE WEEKS AGO PATIENT DISLOCATED AGAIN BENDING OVER PULLING WEEDS. REVISION SURGERY WAS PERFORMED AND OXINIUM FEM HD 12/14 28MM -3 AND R3 20 DEG +4 XLPE ACET LNR 28MM X 46MM WERE EXPLANTED.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 10651605 ↗
• InjuryMar 5, 2020Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. PATIENT HAD DIABETIC REFLUX AND HYPERTENSION. SURGEON USED PREVIOUS INCISION TO OPEN JOINT AND DISLOCATED THE HIP. HEAD AND LINER WAS REMOVED VIA PUNCH. STEM WAS REMOVED VIA FLEXIBLE OSTEOTOMES AND REMOVAL TOOL. CUP REMOVED BY EXPLANT. CEMENT SPACER INSERTED. ORIGINAL SURGERY PERFORMED ON (B)(6) 2019 DUE TO RHEUMATOID ARTHRITIS.

  Patient problems: Injury

  MAUDE report 9792392 ↗
• InjuryFeb 3, 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 DUE TO AN INFECTION. HEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9658978 ↗
• InjuryFeb 1, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION OF TOTAL HIP WAS PERFORMED DUE TO INSTABILITY. FURTHER INFORMATION IS UNKNOWN YET.

  Patient problems: Injury

  MAUDE report 8299097 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. PATIENT HAD ACUTE INFECTION, SURGEON PERFORMED LINER AND HEAD EXCHANGE WITH WASHOUT AND DEBRIDEMENT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7954060 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K021673, 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