R3 71337546Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010598455), received between Feb 15, 2021 and Nov 11, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A DISLOCATION OF THE RIGHT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021, IN WHICH A R3 3 HOLE HA CTD ACET SHELL 46MM, REF SPHER HEAD SCREW 40MM, TWO(2) REF SPHER HEAD SCREW 30MM, A COCR 12/14 FEM HEAD 28 +0 AND A R3 0 DEG XLPE ACET LNR 28MM X 46MM WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12796346 ↗
• MalfunctionMay 14, 2021Fitting Problem; Incomplete or Inadequate Connection; Fitting Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A THR, A 0 DEGREES XLPE ACET LNR 28MM X 46MM WOULD NOT SEAT INTO CUP. ANOTHER LINER OF THE SAME ITEM NUMBER WAS OPENED AND IT SEATED PERFECTLY. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826946 ↗
• MalfunctionApr 19, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING THR SURGERY, THE R3 0 DEGREE XLPE ACETABULAR LINER 28 MM INNER DIAMETER X OUTER DIAMETER COULD NOT BE FIXED IN THE CUP. AFTER MULTIPLE ATTEMPTS, THE DEVICE COULD NOT BE USED AND A BACKUP DEVICE FROM SMITH AND NEPHEW WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE FINISHED WITH A DELAY OF LESS THAN 30 MINUTES AND NO INJURY TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683762 ↗
• InjuryFeb 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION BETWEEN THE LINER AND THE FEMORAL HEAD. THE SURGEON SAYS THE DEVICES WERE NOT DEFECTIVE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 11326452 ↗

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.