R3 71332752Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03596010597984), received between Jul 24, 2018 and Jul 29, 2025 — classified as 17 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN THE STERILE BOX WAS OPENED, THE SEAL PACKAGE WITHIN THE BOX WAS COMPROMISED, AND THE R3 0 DEG XLPE ACET LNR 36MM X 52MM SLIPPED OUT ONTO THE FLOOR. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22644745 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A DISLOCATION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH THE R3 0 DEG XLPE ACET LNR 36MM X 52MM AND THE OXINIUM FEM HD 12/14 36 MM +0 WERE EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 21343661 ↗
• MalfunctionDec 20, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE INNER PLASTIC OF THE R3 0 DEG XLPE ACET LNR 36MM X 52MM DEVICE WAS FOUND TO BE UNPROPERLY SEALED. THEREFORE, UPON GRABBING THE PLASTIC WRAPPED IMPLANT, THE IMPLANT ITSELF SLID THROUGH THE WHOLE AND FELL OUT OF THE PACKAGING, LANDING ON THE FLOOR OF THE OPERATING ROOM. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY USING A S+N BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. 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 16014896 ↗
• InjuryMay 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR ON EIGHT YEARS AGO, THE PATIENT EXPERIENCED A FORCED TRAUMATIC DISLOCATION. IT WAS REDUCED AND SUBSEQUENTLY DISLOCATED AGAIN. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO EXCHANGE THE R3 0 DEG XLPE ACET LNR 36MM X 52MM. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 14283174 ↗
• InjuryDec 7, 2021Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT DURING THR, THE R3 0 DEG XLPE ACET LNR 36MM X 52MM WAS NOT ENGAGING THE CUP AFTER IMPLANTATION. IT WAS OBSERVED THAT THE LOCKING MECHANISM OF THE LINER WAS BROKEN. A NEW LINER WAS USED AND WENT IN WITHOUT COMPLICATION. NO DELAY WAS REPORTED. PATIENT WAS NOT HARMED BEYOND THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12952358 ↗
• MalfunctionJan 25, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE LINER WOULD SIMPLY NOT SEAT INTO THE CUP. UNKNOWN HOW THE PROCEDURE FINISHED, IF OCCURRED A SURGICAL DELAY AND HOW THE PROCEDURE FINISHED. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11227065 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE THE PATIENT PRESENTED A FRANK INFECTION. THE PATIENT WOULD HAVE RECEIVED A COURSE OF ANTIBIOTICS TO COVER THE INFECTION, BUT IT DIDN'T WORK, SO THE SURGEON TOOK FLUID AND TISSUE SAMPLES. THEN SOME SOFT TISSUE DEBRIDEMENT WAS UNDERTAKEN AND THE HIP JOINT SOAKED WITH BETADINE SOLUTION, CHLORHEXIDINE, AND HYDROGEN PEROXIDE. AFTER, THE SURGEON REPLACED THE LINER AND HEAD. THIS COMPLAINT IS AGAINST THE LINER. FINALLY, THE SURGEON CLOSED THE WOUND AND APPLIED A DRESSING.

  Patient problems: Bacterial Infection

  MAUDE report 11169165 ↗
• InjuryJan 4, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT, AFTER A THR PROCEDURE, THE PATIENT WAS REVISED BECAUSE A 52 LINER WAS IMPLANTED INTO A 54 SHELL. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11109063 ↗
• InjuryDec 15, 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 THR WAS PERFORMED DUE TO A POSTSURGICAL INFECTION THAT COMPROMISED THE JOINT SPACE. A NEW R3 0 DEG XLPE ACET LNR 36MM X 52MM WAS IMPLANTED. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11009180 ↗
• InjurySep 25, 2020Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE SURGEON DUE TO INCREASE DISCOMFORT TO HER HIP WHERE SHE HAD A TOTAL HIP REPLACEMENT A YEAR AGO. AN X-RAY OF HER HIP SHOWS THAT THE OUTER METAL RING FROM THE R3 CONSTRAINED LINER HAS BROKEN OFF. XRAY ATTACHED. AS THIS OUTER RING DOES NOT AFFECT THE LOCKING MECHANISM OF THE LINER TO THE CUP AND THE HIP IS STILL QUITE STABLE, THE SURGEON DECIDED TO LEAVE IT AS REVISION SURGERY MAY POSE BIGGER RISKS. THE SURGEON WILL CONTINUE TO MONITOR CLOSELY CHANGING AND IF THE DISCOMFORT INCREASE IT WILL BE PERFORMED A POSSIBLE REVISION SURGERY. THE SURGEON BLAMES THE DEVICE. THE PATIENT DID NOT SUFFER ANY PRE-EXISTING CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE EVENT.

  Patient problems: Discomfort; Injury

  MAUDE report 10589307 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THR PROCEDURE, PATIENT WAS EXAMINED UNDER EXPLORATORY HIP SURGERY TO REMOVE HETEROTOPIC OSSIFICATION IN (B)(6) OF THIS YEAR. THE SURGERY WAS NOT EXTENDED INTO THE HIP CAPSULE AND NO IMPLANTS WERE EXCHANGED. ON (B)(6), HIP REVISION WAS PERFORMED FOR ACUTE TROCHANTERIC BURSITIS. INFLAMMATION OF THE TISSUE CONTINUING DOWN TO THE IMPLANT WAS FOUND. A POSSIBLE INFECTION IS SUSPECTED. HEAD AND LINER WERE EXCHANGED, INCLUDING DEBRIDEMENT PROCEDURE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10259490 ↗
• InjuryApr 27, 2020Unintended Movement; Unintended Movement

  PATIENT HAD LEFT TOTAL HIP REPLACEMENT (B)(6) 2016. PATIENT HAD DISLOCATED HIP ON AN UNKNOWN DATE AND AGAIN HAD SECOND DISLOCATION ON (B)(6) 2020. PATIENT WAS REVIEWED BY SURGEON WHO DETERMINED REVISION SURGERY WAS REQUIRED TO TREAT UNSTABLE HIP. REVISION SURGERY COMPLETED ON (B)(6) 2020, WHERE LATERALISED LINER WAS USED WITH +4MM FEMORAL HEAD TO INCREASE OFFSET AND LEG LENGTH. SURGEON WAS HAPPY THAT THESE REVISED IMPLANTS GAVE THE HIP GREATER STABILITY.

  Patient problems: Injury

  MAUDE report 10002867 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO A BILATERAL PULMONARY EMBOLISM. THE EVENT WAS TREATED WITH MEDICATION THERAPY AND THE PATIENT WAS DISCHARGED THE NEXT DAY.

  Patient problems: Injury

  MAUDE report 9413701 ↗
• InjuryNov 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE LINER AND HEAD WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9315174 ↗
• InjuryAug 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO A LEFT THR DUE TO INFECTION. LINER AND FEMORAL HEAD WERE REMOVED AND REPLACED. DEBRIDEMENT AND WASHOUT PERFORMED. SURGEON DOES NOT BLAME THE IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 8929131 ↗
• InjuryApr 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT SUFFER A DISLOCATION ON (B)(6) 2012 AND 2 DAYS LATER HAD A SECOND DISLOCATION.

  Patient problems: Injury

  MAUDE report 8476643 ↗
• InjuryFeb 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO RECURRENT DISLOCATION AND INSTABILITY.

  Patient problems: Joint Dislocation

  MAUDE report 8365006 ↗
• InjuryNov 16, 2018Fracture; Fracture

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BONE FRACTURE AROUND THE STEM. STEM AND FEMORAL HEAD WERE REPLACED AND FRACTURE WAS FIXED WITH ACCORD CABLE. THE CAUSE OF THIS FRACTURE WAS PATIENT FALL.

  Patient problems: Injury

  MAUDE report 8077681 ↗
• InjurySep 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. A THR SYSTEM WAS IMPLANTED.

  Patient problems: Injury

  MAUDE report 7919836 ↗
• InjuryJul 24, 2018Loose or Intermittent Connection; Device Dislodged or Dislocated; Loose or Intermittent Connection; Device Dislodged or Dislocated

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

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7716749 ↗

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.