R3 71338687Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556113189), received between Sep 7, 2018 and Nov 4, 2024 — classified as 5 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K093363, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER AN THR HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED INSTABILITY ON THE HIP. TO CORRECT THIS ISSUE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, TO CONVERT TO A OR3O DUAL MOBILITY. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Failure of Implant

  MAUDE report 20599959 ↗
• InjuryJun 29, 2022Degraded; Device Dislodged or Dislocated; Degraded; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER A TOTAL HIP REPLACEMENT PROCEDURE PERFORMED ON 2016; THE PATIENT EXPERIENCED A FALL THAT LED TO SEVERAL DISLOCATIONS AND A SUBSEQUENT DAMAGE TO THE LINER. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2022. THE PATIENT IS CURRENTLY WELL AND RECOVERING.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 14861223 ↗
• InjuryMay 31, 2021Biocompatibility; Biocompatibility

  *EU LEGAL* IT WAS REPORTED THAT, AFTER A THR PERFORMED ON (B)(6) 2014, THE PLAINTIFF EXPERIENCED HIGH FEVER AND HIGH LEVELS OF COCR IN BLOOD. A TWO-STAGE REVISION SURGERY WAS PERFORMED TO TREAT THESE ADVERSE EVENTS; ON (B)(6) 2020 THE DEVICES WERE EXPLANTED, AND A CEMENT SPACER WAS APPLIED, LEAVING THE PLAINTIFF WITH NO MOBILITY. THEN ON (B)(6) 2020 THE REVISION SURGERY WAS COMPLETED WITH THE IMPLANTATION OF NEW PROSTHESIS. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Fever; Loss of Range of Motion; Metal Related Pathology

  MAUDE report 11907560 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A 2ND STAGE REVISION ON (B)(6) 2020 DUE TO A LEFT THR INFECTION, PATIENT HAD ANOTHER INFECTION IN THE SAME HIP THEREFORE HAD A FIRST STAGE REVISION LEFT THR ON (B)(6) 2021. IT WAS INDICATED BY A DISEASES SPECIALIST A REVISION SURGERY TO REMOVE ALL PROSTHESIS AS THE ORGANISM CAUSING THE INFECTION IS SUSCEPTIBLE TO ANTIBIOTIC THAT THE PATIENT IS ALLERGIC. ALL PROSTHESIS WERE REMOVED. 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: Unspecified Infection

  MAUDE report 11284768 ↗
• InjurySep 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A REVISION SURGERY PERFORMED DUE TO DEBILITATING RIGHT HIP PAIN AND INSTABILITY. ALSO, METALLOSIS AND REACTIVE INFLAMMATORY FLUID SURROUNDING THE HIP JOINT WERE DISCOVERED.

  Patient problems: Injury

  MAUDE report 7857946 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093363, 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.