R3 71337658Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010598523), received between Mar 15, 2021 and Mar 22, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 22, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING PRIMARY HIP PROCEDURE, AFTER THE ACETABULAR SHELL IMPLANTATION, THE SURGEON WAS TRYING TO INSERT THE ACETABULAR LINER. THE LINER WAS PUT INSIDE THE PATIENT, INTO THE ACETABULAR SHELL R3, AND WAS NOT STABLE, IT DID NOT LOCK. THE PROCEDURE FINISHED USING A BACKUP DEVICE FROM SMITH AND NEPHEW, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO INJURY TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11540782 ↗
• InjuryMar 15, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THR PRIMARY SURGERY, AFTER THE ACETABULAR SHELL IMPLANTATION, THE SURGEON WAS TRYING TO INSERT THE ACETABULAR LINER BUT WHEN THE R3 20 DEGREE XLPE ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER WAS PUT IN THE ACETABULAR SHELL, WAS NOT STABLE AN COULD NOT LOCKED. THE PROCEDURE WAS FINISHED USING A BACKUP DEVICE FROM SMITH AND NEPHEW WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO INJURY TO THE PATIENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484561 ↗

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.