R3 71334950Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010598110), received between Jul 14, 2021 and May 9, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K113848, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 9, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AFTER A THR SURGERY PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED DISLOCATION ON (B)(6) 2024. THE PATIENT WAS BOOKED FOR AN OPEN REDUCTION PROCEDURE, DURING WHICH IT WAS NOTICED THAT THE HEAD WAS NOT PROPERLY REDUCING INTO THE LINER. UPON REVIEWING THE RECORDS, IT WAS DISCOVERED THAT THERE WAS A MISMATCH BETWEEN THE HEAD AND THE LINER DUE TO THE PLACEMENT OF THE WRONG SIZE OF LINER IN THE PRIMARY SURGERY. DURING THE PRIMARY SURGERY, THE WRONG LINER WAS OPENED, AND EVEN THOUGH THE CORRECT LINER WAS REQUESTED, BOTH LINERS WERE OPENED ON THE TABLE, AND THE WRONG LINER WAS HANDED. DUE TO THE UNAVAILABILITY OF THE CORRECT LINER SIZE DURING THE OPEN REDUCTION PROCEDURE, THERE WAS A FOUR-HOUR DELAY WHILE AWAITING THE APPROPRIATE LINER SIZE. FOLLOWING THIS DELAY, THE INCORRECT LINER, A R3 20 DEG XLPE ACET LNR 28MM X MM50, WAS EXCHANGED FOR THE CORRECT SIZE, A R3 20 DEG XLPE ACET LNR 32MM X 50MM. THE PATIENT IS CURRENTLY IN THE PROCESS OF RECOVERING.

  Patient problems: Joint Dislocation

  MAUDE report 19280010 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THA, AN OXINIUM FEM HD 12/14 28MM +4 AND A R3 20 DEG XLPE ACET LNR 28MM X MM50 WERE DISLOCATED WHICH LED TO REVISION SURGERY. SURGERY HAD BEEN COMPLETED WITH A BACK-UP DEVICE. CURRENT HEALTH STATUS OF THE PATIENT IT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12165988 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113848, 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-1929-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
• Z-1928-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.