R3 71335762Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010598387), received between Nov 21, 2018 and Sep 17, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Fitting Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT DURING A THR SURGERY, A R3 20 DEG XLPE ACET LNR 36MM X 62MM AND A R3 3 HOLE ACET SHELL 62MM WERE IMPLANTED. THE SURGEON PROCEEDED TO TRIAL THE STEM AND HEAD BUT WERE LOOSE, THEREFORE THE SURGEON WANTED TO ANTEVERT THE LINER TO PREVENT HIP DISLOCATION. HE ATTEMPTED TO USE A LINER EXTRACTOR TOOL FOR 15 MINUTES TO EXTRACT THE LINER FROM THE SHELL, BUT IT WOULD NOT WORK. IT WAS GOING TO PROCEED TO USE FLEXIBLE DRILL 15MM AND A REF SPHER HEAD SCREW 25MM TO REMOVE LINER BUT THEN OPTED TO REAM TO 64 SHELL AND LINER. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: Laceration(s)

  MAUDE report 20238408 ↗
• InjurySep 10, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING THR SURGERY, THE R3 XLPE 20 DEGREE ACETABULAR LINER 36 MM X 62 MM DID NOT LOCK INTO THE R3 SHELL, THEN THE LINER WAS REMOVED. SURGEON CHECKED THE SOFT TISSUE CLEARANCE, AND MADE SURE THE SCREW AND THE CENTRAL HOLE COVER WERE NOT SITTING PROUD. THE SURGEON TRIED 3 MORE TIMES TO SEAT THE LINER WITHOUT SUCCESS. A SMALL LINER 32 MM X 62 MM WAS OPENED AND INSERTED EASILY AND QUICKLY, AND THE SURGERY CONTINUED AS PLANNED. THERE WAS A DELAY OF LESS THAN 30 MINUTES. NO OTHER COMPLICATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10515262 ↗
• InjuryNov 21, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. PATIENT HAD A SIGNIFICANT PRE-OP DEFORMITY OWING TO A PREVIOUS SEPTIC ARTHRITIS IF THE HIP JOINT. THERE HAS BEEN NO SIGN OF ACTIVE INFECTION IN THE HIP JOINT FOR MANY YEARS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8094152 ↗

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.