R3 71337950Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010598646), received between Mar 20, 2018 and Mar 28, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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.

• InjuryMar 28, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2014, THE PATIENT EXPERIENCED A BAD FALL AND POSTERIOR CONTINUES DISLOCATIONS. THIS ADVERSE EVENT WAS ADDRESS THROUGH A REVISION SURGERY, (B)(6) 2023, IN WHICH THE SURGEON WAS AWARE THAT THE R3 20 DEG +4 XLPE ACET LNR 32MM X 50MM WAS BROKEN, THEREFORE THE R3 0 HOLE ACET SHELL 50MM AND THE R3 20 DEG +4 XLPE ACET LNR 32MM X 50MM WERE EXPLANTED AND CHANGED FOR A R3 MULTI-HOLE CUP AND A CONSTRAINED LINER. PATIENT STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 16632824 ↗
• InjuryMar 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A CORTISONE INJECTION WAS REQUIRED DUE TO RIGHT LATERAL HIP PAIN.

  Patient problems: Pain

  MAUDE report 7352708 ↗

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-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.
• 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.