R3 71334948Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010598103), received between Feb 5, 2020 and Nov 11, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PRIMARY THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY REVISION THR SURGERY ON (B)(6) 2024, IN WHICH ONE (1) R3 0 HOLE HA CTD ACET SHELL 48MM, ONE (1) REF INTERFIT THRD HOLE COVER, ONE (1) R3 20 DEG XLPE ACET LNR 28MM X 48MM AND ONE (1) OXINIUM FEM HD 12/14 28MM +0 WERE EXPLANTED AND REPLACED WITH A COMPETITOR PRODUCT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 20653309 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THA HAD BEEN PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED DISLOCATION/SUBLUXATION. THEREFORE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2018 WHERE R3 0 HOLE HA CTD ACET SHELL 48MM (CASE-(B)(4)), R3 20 DEG XLPE ACET LNR 28MM X 48MM (CASE-(B)(4)), OXINIUM FEM HD 12/14 28MM +0 (CASE-(B)(4)) AND POLARSTEM STEM STD TI/HA 01 NON-CEM (CASE-(B)(4)) WERE EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY (B)(6) AND THE ISLE OF MAN SUPPLIER FEEDBACK; THEREFORE, FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Joint Dislocation; Subluxation

  MAUDE report 12239827 ↗
• InjuryFeb 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD LOW HAEMOGLOBIN AND LOW BLOOD PRESSURE. PATIENT RECEIVED 2 UNITS OF BLOOD TRANSFUSION.

  Patient problems: Injury

  MAUDE report 9670703 ↗

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.