R3 71337656Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010598516), received between Jul 23, 2018 and Nov 24, 2023 — classified as 4 injuries, 1 malfunction.

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

• InjuryNov 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, DUE TO A FRACTURED FEMUR NECK, AND DURING SURGERY, IT WAS DIFFICULT TO GAUGE LEG LENGTH AND OFFSET. THEN THE PATIENT EXPERIENCED DISLOCATION AND FELT THE HIP DISLOCATE AND RELOCATE WHILST ROLLING IN BED. ADDITIONALLY, PATIENT'S X-RAY SHOWED THAT THE LEG LENGTH AND OFFSET OF THE THR WERE BOTH SLIGHTLY SHORT. AS A RESULT OF THIS ADVERSE EVENT, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023, IN WHICH A R3 20 DEG XLPE ACET LNR 32MM X 56MM AND A OXINIUM FEM HD 12/14 32MM +4 WERE EXCHANGED. PATIENT WAS DISCHARGED AND RECOVERING WELL.

  Patient problems: Joint Dislocation

  MAUDE report 18204409 ↗
• MalfunctionMay 28, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING THA, THE R3 20 DEG XLPE ACET LNR 32MM X 56MM WAS LOOSE, CAME OFF, AND COULD NOT BE FIXED PROPERLY TO THE R3 56 3-HOLE SHELL. THE SURGEON TRIED THREE TIMES TO INSTALL THE LINER, BUT KEEP HAVING THE SAME ISSUE. A BACK-UP DEVICE WAS AVAILABLE AND WAS ABLE TO BE INSTALLED PROPERLY. NO SURGICAL DELAY WAS REPORTED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. 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 11904799 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT'S HIP GOT DISLOCATED. THERE IS NO INFORMATION REGARDING THE PROCEDURE THAT WAS PERFORMED NOR WHEN THE EVENT OCCURRED.

  Patient problems: Joint Dislocation

  MAUDE report 11054977 ↗
• InjuryJan 29, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING SURGERY, LINER WAS DIFFICULT TO GET INTO THE R3 CUP. SURGEON BROACHED FOR THE STEAM AND TRIALED, WHEN PATIENT DISLOCATED THE HIP THE LINER POPPED OUT. THIS REQUIRED EXCHANGE LINER FROM 32MM TO 36MM AND MINOR DELAY WAS REPORTED. IF SMITH AND NEPHEW BACK WAS USED IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 8286836 ↗
• InjuryJul 23, 2018Mechanical Problem; Device Dislodged or Dislocated; Mechanical Problem; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE SURGEON DOES NOT FAULT THE DEVICE. THE PRODUCT IS NOT AVAILABLE. NO MORE INFORMATION AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7712727 ↗

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.