R3 71332760Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010598028), received between Nov 13, 2018 and Jan 9, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).

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

• MalfunctionJan 9, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A THR SURGERY, A PACKAGING ISSUE WAS IDENTIFIED WITH ONE (1) R3 0 DEG XLPE ACET LNR 36MM X 60MM. THE OUTER BOX WAS CELLOPHANE-WRAPPED; HOWEVER, INSIDE THE BOX, THE DOUBLE BLISTER CONTAINING THE DEVICE WAS FOUND TO BE OPEN. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24028642 ↗
• MalfunctionMar 3, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP OR INSPECTION, WHEN OPENED THE ONE (1) R3 0 DEG XLPE ACET LNR 36MM X 60MM BOX, IT WAS NOTICED A RIP IN THE PACKAGING ALL THE WAY TO THE LINER. THE LINER WAS NOT STERILE. THE PROCEDURE WAS COMPLETED AFTER A NON-SIGNIFICANT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21503761 ↗
• InjuryAug 17, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2016 THE PATIENT EXPERIENCED INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. THE PATIENT HAD A REVISION OF THE RIGHT HIP VIA POSTERIOR APPROACH WITH WOUND DEBRIDED AND IRRIGATED. WOUND SAMPLES SENT TO PATHOLOGY. FEMORAL HEAD REMOVED WITH BONE PUNCH, AND LINER REMOVED WITH LINER REMOVAL TOOL. WOUND IRRIGATED WITH BETADINE. NEW LINER AND HEAD OF THE SAME PREVIOUS SIZING INSERTED TO RETAINED SHELL AND STEM AS PER STANDARD TECHNIQUE WITH LINER IMPACTOR AND FEMORAL HEAD IMPACTOR. DRAINS INSERTED AND WOUND CLOSED IN LAYERS AS PER STANDARD TECHNIQUE.

  Patient problems: Unspecified Infection

  MAUDE report 12331685 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO RECURRENT DISLOCATIONS.

  Patient problems: Joint Dislocation

  MAUDE report 8485195 ↗
• InjuryNov 13, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE SURFACE OF REMOVED LINER AND OX HEAD WAS DAMAGED AND FOUND THAT THERE HAVE BEEN LOT OF SCRATCHES. NO DELAY OR BACK UP REPORTED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8065062 ↗

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.