R3 71335758Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010598363), received between Aug 10, 2018 and Jan 8, 2025 — classified as 10 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THEY REPLACED ONE (1) R3 20 DEG XLPE ACET LNR 36MM X 58MM AND ONE (1) OXINIUM FEM HD 12/14 36 MM +0 WITH A 40X58 POLY AND SZ40 +8 HEAD. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 21107967 ↗
• InjurySep 25, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER A THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2023, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS BETWEEN THE FEMORAL HEAD AND THE POLY LINER. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A R3 20 DEG XLPE ACET LNR 36MM X 58MM AND A COCR 12/14 FEM HEAD 36MM +0 WERE EXPLANTED AND EXCHANGED BY A CONSTRAINED LINER TO ASSIST. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: Joint Dislocation

  MAUDE report 20302172 ↗
• InjuryJan 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED DISLOCATION AND MUSCLE WEAKNESS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2022, IN WHICH A R3 20 DEG XLPE ACET LNR 36MM X 5 WAS EXPLANTED AND A CONSTRAINED LINER IMPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation; Muscle Weakness/Atrophy

  MAUDE report 16098357 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THA A REVISION SURGERY WAS NECESSARY AND THE DEVICES IMPLANTED WERE REMOVED IN ORDER TO IMPLANT NEW ONES AT A DIFFERENT ANGLE. THE PATIENT WAS NOT INJURED.

  Patient problems: Failure of Implant

  MAUDE report 11722556 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THE SECOND SURGERY DUE TO THE FRACTURE ON (B)(6) 2020 THE PATIENT GOT INFECTED THEREFORE IT WAS DONE A REVISION SURGERY ON (B)(6) 2021. ALL IMPLANTS WERE REMOVED. ( OXINIUM FEM HD 12/14 36 MM -3, REDAPT SLVLS MONO STEM 190MM SZ 19 SO, R3 3 HOLE ACET SHELL 58MM, R3 20 DEG XLPE ACET LNR 36MM X 58MM, TWO REF SPHER HEAD SCREW 20MM, THREE ACC 2.0MM COCR CABLE W/CLAMP.) THOSE IMPLANTS WERE REPLACED, EXCEPTED FOR THE FLEXIBLE OSTEOTOMES USED TO REMOVE THE REDAPT SLVLS MONO STEM 190MM SZ 19 SO AND ALSO WAS IMPLANTED FOUR CC 2.0MM COCR CABLE W/CLAMP. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11263355 ↗
• MalfunctionDec 30, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A THR SURGERY ,THE LINER DID NOT SIT DOWN ALL THE WAY. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO 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 11096990 ↗
• InjuryJul 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY OF PRIMARY THR (B)(6) 2020. IT WAS INFORMED THAT THE PATIENT HAD ANOTHER REVISION SURGERY IN (B)(6) 2020, BECAUSE IT PRESENTED A PERIPROSTHETIC FRACTURING FEMUR. THE SURGEON REMOVED THE FEMORAL PROSTHESIS AND THE FEMORAL HEAD. ALSO, IT WAS KNOWN THAT THE STEM WAS SUBSIDED. THE SURGEON FIXED THE PROBLEM WITH THREE CABLES. THE SURGEON DID NOT BLAME THE DEVICES IN THE DEVELOPMENT OF THE PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration

  MAUDE report 10230703 ↗
• InjuryDec 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS RE ADMITTED ON THE HOSPITAL DUE TO PAIN, HE WAS TREATED WITH MEDICATION.

  Patient problems: Pain

  MAUDE report 9530978 ↗
• InjuryDec 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS RE ADMITTED ON THE HOSPITAL DUE TO PAIN, HE WAS TREATED WITH MEDICATION.

  Patient problems: Pain

  MAUDE report 9530870 ↗
• InjuryMar 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON THE PATIENT DUE TO DISLOCATION. NO ADDITIONAL DETAILS OF THE REVISION SURGERY REPORTED. THREE EXPLANTS REPORTED. NO DELAY OR ADDITIONAL INJURIES REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8448781 ↗
• InjuryAug 10, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED AT FIRST STAGE REVISION LEFT HIP, WHERE THE PATIENT HAD INFECTION. A REVISION HIP WAS DONE ORIGINALLY ON THE (B)(6) 2017 AFTER A PERIPROSTHETIC FRACTURE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 7773325 ↗

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.