R3 71332762Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010598035), received between Nov 21, 2018 and May 13, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 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 A THR SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FIVE DISLOCATIONS OF THE HIP. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A R3 0 DEG XLPE ACET LNR 36MM X 62MM WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 19296531 ↗
• MalfunctionDec 7, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING THR SURGERY, WHEN OPENING AN R3 0 DEG XLPE ACET LNR 36MM X 62MM, THE IMPLANT FELL ONTO THE FLOOR. IT WAS NOTICED THAT THE PACKAGING HAD A SPLIT IN THE INTERNAL AND EXTERNAL PLASTIC PACKAGING, THE PLASTIC PACKAGING WAS SEALED AT BOTH ENDS, HOWEVER THE SPLIT WAS ON THE SIDE EDGE OF THE PACKAGING. THE EXTERNAL BOX APPEARED TO BE SEALED AND UNOPENED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287575 ↗
• InjuryNov 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN IR DRAIN WAS DONE TO THE PATIENT DUE TO PERSISTENT INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8096891 ↗
• InjuryNov 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS DONE WITH THE PLACEMENT OF ANTIBIOTIC IMPREGNATED BEADS. DEVICES WERE RETAINED.

  Patient problems: Unspecified Infection

  MAUDE report 8096093 ↗
• InjuryNov 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN ASPIRATION OF THE LEFT HIP WAS PERFORMED DUE TO A THIGH SEROMA AND PROSTHETIC JOINT INFECTION. OPEN IRRIGATION AND DEBRIDEMENT WAS DONE.

  Patient problems: Unspecified Infection

  MAUDE report 8095923 ↗

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.