R3 71332756Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 03596010598004), received between May 3, 2017 and Aug 22, 2024 — classified as 19 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT DA THR SURGERY THAT HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH ONE (1) R3 0 DEG XLPE ACET LNR 36MM X MM56 AND ONE (1) OXINIUM FEM HD 12/14 36 MM M/+4 WERE CHANGED. THE PATIENT REPORTEDLY COMPLIED WITH ALL POST-OPERATIVE INSTRUCTIONS AND ITS CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20031017 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2022 THE PATIENT EXPERIENCED DISLOCATION DUE TO THE COMPONENTS BEING PLACED IN A SUB-OPTIMAL POSITION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY TO EXPLANT THE COMPLETE SYSTEM ON (B)(6) 2022. THE PHYSICIAN REVISED AN R3 0 DEG XLPE ACET LNR 36MM X MM56. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 13591666 ↗
• MalfunctionFeb 17, 2022Positioning Problem; Material Split, Cut or Torn; Positioning Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE R3 0 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 56MM DID NOT LOCK IN THE CUP, THERE WAS A SMALL TEAR IN IT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549193 ↗
• InjuryDec 7, 2021Biocompatibility; Biocompatibility

  US LEGAL - IT WAS REPORTED THAT, AFTER A LEFT THR ON (B)(6) 2012 DUE TO OSTEOARTHRITIS, PLAINTIFF HAS EXPERIENCED AN IMPLANT MECHANICAL FAILURE, SIGNIFICANT ELEVATED COBALT CHROMIUM LEVELS AND AN MRI SHOWED AN ABDUCTOR MUSCLE TENDON TEAR. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 WHERE IT WAS FOUND A PSEUDOTUMOR ENGULFING THE ABDUCTOR MUSCLE, AFTER A DEBRIDED THERE WAS A LARGE DISRUPTION OF THE ENTIRE MUSCLE AND IT WAS NOTICED THE FEMORAL COMPONENT DOWN TO THE ACETABULAR COMPONENT AND CORROSION AT THE MODULAR NECK TO STEM INTERFACE. THE R3 3 HOLE ACET SHELL 56MM REMAINED AND WAS NOT EXPLANTED. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Laceration(s); Metal Related Pathology

  MAUDE report 12952978 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A THR IT WAS IMPLANTED THE WRONG LINER (R3 0 DEGREES XLPE ACET LNEER36MM X MM56) FOR THE 40MM HEAD USED IN THE CASE. THIS ISSUE WAS HANDLED A DAY AFTER THE PROCEDURE USING THE SAME DEVICE, BUT THIS TIME USING THE CORRECT LINER. THE REALIZATION OF THIS PROBLEM WAS AFTER THE SURGERY. THIS DID NOT CAUSE ANY INJURE TO THE PATIENT AND NOT SIGNIFICANT DELAY WAS CAUSED BY THE MISTAKE. NO OTHER COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11722552 ↗
• MalfunctionMar 15, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT, DURING A THR THE R3 0 DEG XLPE ACET LNR 36MM X MM56 CANNOT BE ANCHORED IN THE CUP. LOOK 2-3MM OUT OF THE CUP. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH-NEPHEW BACK-UP DEVICE. 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 11480214 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THERE WAS A REVISION SURGERY BECAUSE THE PATIENT HAD TWO DISLOCATIONS. THE R3 0 DEG XLPE ACET LNR 36MM X MM56 AND OXINIUM FEM HD 12/14 36 MM WERE EXPLANTED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 11248354 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF A TOTAL HIP REPLACEMENT WAS PERFORMED DUE TO SEVERAL DISLOCATION. THE PATIENT PRESENTED WITH A WELL FIXED ANTHOLOGY AND R3 CUP, WHICH HAD BEEN IMPLANTED IN 2018. THE HEAD AND LINER WERE REMOVED AND A TRIAL WITH OR3O PROVED TO PROVIDED ADEQUATE ROM WITHOUT SUBLUXATION.

  Patient problems: Joint Dislocation

  MAUDE report 10904344 ↗
• InjuryNov 25, 2020Adverse 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 AN INFECTION, 2 MONTHS POST TOTAL HIP ARTHROPLASTY. THE JOINT WAS WASHED OUT, AND THE POLY WAS EXPLANTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10902322 ↗
• MalfunctionAug 26, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A THR PROCEDURE THE SURGEON WAS NOT ABLE TO LOCK THE ARTICULAR INSERT INTO THE ACETABULUM CUP. THE SURGEON CLEARED ALL SOFT TISSUE AND RETIRED 2 MORE TIMES TO INSERT THE INSERT. AFTER THE 3RD UNSUCCESSFUL ATTEMPT A NEW ARTICULAR INSERT WAS OPENED AND THE SURGEON WAS ABLE TO SUCCESSFULLY SEAT THE ARTICULAR INSERT ON THE FIRST ATTEMPT. NO HARM CAME TO THE PATIENT AND IT ADDED AN EXTRA MINUTE TO THE OVERALL PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10457324 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED IN WHICH A SPECTRON/R3 SYSTEM WAS IMPLANTED, THE PATIENT EXPERIENCED PAIN AND SYMPTOMS OF INFECTION, WHICH RESULTED IN WOUND BREAKDOWN. THE PATHOLOGY REVEALED THAT A GENTAMYCIN-RESISTANT ORGANISM WAS PRESENT FROM PREVIOUS TESTS. THE FIRST-STAGE REVISION SURGERY WAS PERFORM TO TREAT THE INFECTION: FLUID AND TISSUE SAMPLES WERE TAKEN OUT AND THE RETRIEVED IMPLANTS WERE SENT FOR SONICATION PATHOLOGY TESTING. THE CEMENT SPACER WAS PLACED IN SITU. THE SECOND-STAGE REVISION SURGERY WILL BE CONDUCTED AFTER THE LONG-TERM ANTIBIOTIC TREATMENT THAT IS NECESSARY TO ADDRESS THE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10076074 ↗
• InjuryDec 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS A POLARSTEM DEVICE IN PLACE SINCE 2017 AND WAS EXPERIENCING ELEVATED COBALT LEVELS. REVISION SURGERY WAS PERFORMED AND THE POLY WAS EXPLANTED AND AN OXINIU HEAD WAS USED.

  Patient problems: Injury

  MAUDE report 9513573 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A RIGHT HIP CLOSED REDUCTION WAS PERFORMED DUE TO SUPERIOR FEMUR DISLOCATION OF THE FEMORAL PROSTHESIS OUT OF THE ACETABULAR CUP.

  Patient problems: Joint Dislocation

  MAUDE report 9186741 ↗
• InjurySep 20, 2019Unstable; Unstable

  IT WAS REPORTED A RIGHT HIP REVISION SURGERY DUE TO SEVERE PAIN AND INSTABILITY.

  Patient problems: Injury

  MAUDE report 9101208 ↗
• InjurySep 20, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION.

  Patient problems: Injury

  MAUDE report 9101202 ↗
• InjuryAug 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND BONE LOSS.

  Patient problems: Pain

  MAUDE report 8904440 ↗
• InjuryMay 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 8634430 ↗
• InjuryApr 7, 2019Misassembled; Misassembled

  IT WAS REPORTED THAT REVISION SURGERY WAS CARRIED OUT FOR A HIP PROSTHESIS EXCHANGE DUE TO IT BROKE AT THE SHAFT.

  Patient problems: Injury

  MAUDE report 8489943 ↗
• InjuryDec 27, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED A PATIENT FELL IN THE SHOWER. ATTEMPTS TO FIX THE DISLOCATION WITHOUT SURGERY FAILED, SO SURGEON DECIDED TO REPLACE THE HEAD AND LINER TO ASSURE THERE WOULD NOT BE FURTHER DISLOCATIONS.

  Patient problems: Failure of Implant

  MAUDE report 7147379 ↗
• InjurySep 6, 2017Connection Problem; Device Slipped; Connection Problem

  IT WAS REPORTED THAT SURGEON WAS UNABLE TO LOCK THE LINER INSIDE ACETABULAR SHELL DURING THR SURGERY, LEADING TO SURGICAL EXTENSION.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 6845145 ↗
• InjurySep 6, 2017Fitting Problem; Fitting Problem; Connection Problem

  IT WAS REPORTED THAT SURGEON WAS UNABLE TO LOCK THE LINER INSIDE ACETABULAR SHELL DURING THR SURGERY, LEADING TO SURGICAL EXTENSION.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6845144 ↗
• InjuryMay 3, 2017Unstable; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY DUE TO SUSPECTED INFECTION AND INSTABILITY.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 6539750 ↗

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.