R3 71336954Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010622563), received between Sep 29, 2020 and Sep 29, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A PRIMARY SURGERY (THR), DURING THIS SURGERY A LINER, ONE OXINIUM HEAD, 3 SCREWS, AND ONE STEM WERE IMPLANTED. 6 WEEKS POST-OPERATIVE, THE PATIENT PRESENTED A DISLOCATION OF THE THR, FEELING A SLIPPING SENSATION IN CERTAIN POSITIONS. AFTER THAT, A MUA/REVISION OF RIGHT THR WAS PERFORMED. THE SURGEON DID A REVISED THROUGH THE DAA APPROACH AND THE HEAD AND LINER WERE REMOVED AND A NEW LINER AND NEW HEAD WERE IMPLANTED. ADDITIONALLY, IT WAS INSERTED A HOOD OF A LINER POSITIONED LATERALLY FOR EXTRA COVERAGE. THE WOUND WAS IRRIGATED AND CLOSED IN LAYERS AS PER THE TECHNIQUE. 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: Injury

  MAUDE report 10604067 ↗

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.