OXINIUM 71342604Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010488909), received between Mar 25, 2018 and May 6, 2024 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2024, PATIENT EXPERIENCED PAIN, FEELING OF WRONGNESS AND DISLOCATION. SURGEON DID NOT THINK PRODUCTS FAILED. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (B)(6) 2024 TO EXCHANGE TANDEM BIPOLAR TO R3 CUP, OR3O LINER AND INSERT. THE FEMORAL HEAD WAS EXCHANGED TO OXINIUM FEMORAL HEAD. THE STEM WAS REMAINED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19250609 ↗
• MalfunctionOct 9, 2023Delivered as Unsterile Product; Scratched Material; Delivered as Unsterile Product; Scratched Material

  IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS FOUND THERE WAS A WHITE SPOT ON THE TAPER SIDE OF THE OXINIUM FEM HD 12/14 26 MM +4. THE WHITE SPOT COULD NOT BE REMOVED BY FORCEPS; THEREFORE, IT MUST BE A SCRATCH. AS THERE WAS NO BACK UP DEVICE, THE REPORTED WAS INSTALLED TO THE PATIENT. THE SURGERY WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17896584 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED PAIN AND BONE FRACTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A ANTHOLOGY SO POROUS SIZE 6, AN OXINIUM FEM HD 12/14 26 MM + 4 AND A TNDM BP SHL/XLPE LNR 49OD 26ID WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 17095880 ↗
• InjuryMay 23, 2023Unstable; Unstable

  IT WAS REPORTED THAT, AFTER PRIMARY SURGERY HAD BEEN PERFORMED ON (B)(6)2023, IT WAS FOUND THAT THE OXINIUM FEM HD 12/14 26 MM +4 IMPLANTED, WAS UNSTABLE AGAINST THE NECK AND TAPER PART WAS LOCKED BY POSTOPERATIVE X-RAY. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6)2023 WHERE ALL IMPLANTS WHERE EXCHANGED. ALSO, THE EXPLANTED TNDM BP SHL/XLPE LNR 48OD 26ID AND THE SL-PLUS INTEGR MIA STEM WITH TI/HA 5 WERE DAMAGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Laxity

  MAUDE report 16989002 ↗
• InjuryAug 3, 2021Adverse 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) 2021, THE PATIENT EXPERIENCED PAIN AND FRACTURE. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12271323 ↗
• InjurySep 11, 2019Fracture; Fracture

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO SEVERE PAIN AND FRACTURE. DR STATES THAT THIS REVISION WAS NOT CAUSED BY DEVICE BUT PATIENT FELL DOWN.

  Patient problems: Injury

  MAUDE report 8994847 ↗
• InjuryMay 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8610471 ↗
• InjuryMay 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Injury

  MAUDE report 8610468 ↗
• InjuryJan 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Injury

  MAUDE report 8264366 ↗
• InjuryMar 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE TANDEM BIPOLAR SHELL/ XLPE LINER AND THE FEMORAL HEAD WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 7368748 ↗

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