R3 71335754Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 03596010598349), received between Feb 16, 2018 and Dec 14, 2025 — classified as 27 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryDec 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER UNDERGOING A REVISION SURGERY ON AN UNKNOWN DATE, DUE TO DISLOCATION ON THE SAME DAY. PATIENT EXPERIENCED FEMUR FRACTURE ON (B)(6) 2025. IN ADDITION, SURGEON DOES NOT BELIEVE THAT THE FRACTURE WAS CAUSED BY A PRODUCT FAILURE. IT WAS CAUSED BY THE PATIENT'S WEIGHT. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DURING WHICH, THE R3 20 DEG XLPE ACET LNR 32MM X 54MM & OXINIUM FEM HD 12/14 36 MM +0 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 23799570 ↗
• InjurySep 18, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER A THR SURGERY PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A DISLOCATION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 TO REPLACE THE R3 LINER WITH A CONSTRAINED LINER. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20245754 ↗
• InjuryAug 30, 2024Fracture; Device Dislodged or Dislocated; Naturally Worn; Fracture; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT AFTER UNDERGOING A THR ON (B)(6) 2019, PATIENT EXPERIENCED LINER FAILURE. THIS ADVERSE EVENT WAS ADDRESSED BY DOING A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE R3 20 DEG XLPE ACET LNR 36MM X 54MM WAS NOTED TO HAVE DISENGAGED, THE LINER WAS EXCHANGED WITH A NEW ONE OF THE SAME CONFIGURATION. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20107531 ↗
• MalfunctionJul 11, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, WHEN THE BOX OF ONE (1) R3 20 DEG XLPE ACET LNR 36MM X 54MM WAS OPENED, THE IMPLANT FELL OUT. THE IMPLANT PACKAGING (INNER AND OUTER POUCH) WAS DELIVERED UNSEALED, FOR WHICH STERILIZATION OF THE PRODUCT WAS COMPROMISED. AS THIS HAPPENED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727369 ↗
• InjuryMar 1, 2024Adverse 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 AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A R3 20 DEG XLPE ACET LNR 36MM X 54MM AND A OXINIUM FEM HD 12/14 36 MM +0 WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18816540 ↗
• MalfunctionJan 30, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE R3 20 DEG XLPE ACET LNR 36MM X 54MM WAS FOUND TO BE DEFORMED WHILE INSIDE THE PATIENT. SURGERY WAS RESUMED WITH AN EQUIVALENT PRODUCT AFTER A 5 MIN DELAY. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16268530 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER SURGERY HAD BEEN PERFORMED , THE PATIENT EXPERIENCED REOCCURRING HIP DISLOCATIONS. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2022. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 15496093 ↗
• InjuryApr 25, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A PRIMARY HIP REPLACEMENT IN (B)(6) 2019, PATIENT SUFFERED A TRAUMATIC FALL WITH DISLOCATION AND SOFT TISSUE DAMAGE. PATIENT HAD TWO MORE DISLOCATIONS AFTERWARDS. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 IN WHICH THE SUPPORTING MUSCLES WERE NOTED TORN AND NEEDED TO BE REPAIRED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 14192197 ↗
• InjuryDec 9, 2021Biocompatibility; Biocompatibility

  *US LEGAL* IT WAS REPORTED THAT, AFTER A LEFT THR ON (B)(6) 2016 DUE TO END-STAGE DEGENERATIVE JOINT DISEASE OF BOTH HIPS WITH VASCULAR NECROSIS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO A COMPLICATED POSTOPERATIVE COURSE, CHROMIUM AND COBALT LEVELS ON THE IMPLANTS REFLECTED INCREASING COBALT LEVELS IN THE 15-16 RANGE COMBINED WITH FLUID AND INCREASING/PERSISTENT PAIN. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 12966828 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT, AFTER A RIGHT THR ON (B)(6) 2016 DUE TO END-STAGE DEGENERATIVE JOINT DISEASE OF BOTH HIPS WITH VASCULAR NECROSIS. REVISION SURGERY WAS PERFORMED ON (B)(6) 2017 DUE TO PAIN. DURING THE REVISION, DEBRIDEMENT OF SKIN, MUSCLES AND BONES WAS PERFORMED, NOTING A SMALL AMOUNT OF FLUID WITH SOME PURULENCE. A PULSE IRRIGATION WAS PERFORMED WITH AN ANTIBIOTIC SOLUTION. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12964976 ↗
• InjuryOct 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY, THE PATIENT EXPERIENCED AN UNKNOWN ADVERSE EVENT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12701270 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT AFTER A LEFT THA WAS PERFORMED ON (B)(6) 2016, PLAINTIFF EXPERIENCED INCREASING PAIN, EFFUSION ON LEFT HIP, AND HEMATOMA ON THE HIP. AN IRRIGATION AND DEBRIDEMENT OF HEMATOMA, AND DEBRIDEMENT OF LEFT TROCHANTERIC BURSA WAS PERFORMED ON (B)(6) 2019 TO INITIALLY TREAT THESE ADVERSE EVENTS. HOWEVER, PLAINTIFF CONTINUED HAVING ISSUES, INCLUDING HIGH COBALT LEVELS ON BLOOD ((B)(6) 2019: COBALT 19 MCG/L). DUE TO THIS, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019. DURING SURGERY ALL THE S+N DEVICES WERE EXPLANTED, AND NEW DEVICES WERE IMPLANTED. AFTER THE REVISION SURGERY, THE PLAINTIFF EXPERIENCED MULTIPLE INTERVENTIONS INCLUDING A SECOND REVISION SURGERY AND OPEN REDUCTION WITH INTERNAL FIXATION OF LEFT PELVIS FRACTURE, HOWEVER SINCE THERE IS NO INFORMATION ABOUT THE MANUFACTURER FOR ALL DEVICES IMPLANTED ON THE FIRST REVISION SURGERY, DETERMINATION IF SOME OF THE DEVICES ARE FROM S+N CANNOT BE CONCLUDED. A CORRELATION BETWEEN THESE EVENTS AND OUR DEVICES CANNOT BE STABLISH. PLAINTIFF OUTCOME IS UNKNOWN.

  Patient problems: Bone Fracture(s); Hematoma; Infiltration into Tissue; Inflammation; Pain; Swelling/ Edema

  MAUDE report 12638956 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO WASHOUT THE JOINT AND TO EXCHANGE OXINIUM FEM HD 12/14 36 MM L/+8 AND R3 20 DEG XLPE ACET LNR 36MM X 54MM. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12569715 ↗
• MalfunctionSep 21, 2021Contamination; Contamination

  IT WAS REPORTED THAT, DURING A THR, A R3 20 DEG XLPE ACET LNR 36MM X 54MM HAD A BLACK SPECK INSIDE THE PLASTIC BAG. THIS WAS NOTICED BEFORE USE IN PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509443 ↗
• InjuryAug 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, THE R3 20 DEG XLPE ACET LNR 36MM X 54MM SINK INSIDE THE ACETABULUM WHEN IMPACTED, AND THE LOCKS BROKE. SURGERY WAS RESUMED, WITHOUT ANY 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 12320000 ↗
• MalfunctionJun 23, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A THR SURGERY ON JUNE 9TH, A R3 20 DEGREES XLPE ACET LNEER36MM X 54MM WOULD NOT SEAT INTO THE CUP. ANOTHER R3 20 DEGREES XLPE ACET LNEER36MM X 54MM WAS OPENED AND SEATED PERFECTLY. NO SURGICAL DELAY OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053888 ↗
• MalfunctionMay 7, 2021Loose or Intermittent Connection; Fitting Problem; Incomplete or Inadequate Connection; Loose or Intermittent Connection; Fitting Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING THR SURGERY THE R3 20 DEGREES XLPE ACET LNEER36MM X 54MM DIDN'T SEAT INTO CUP AFTER MULTIPLE ATTEMPTS (OUTSIDE PATIENT). THE PROCEDURE WAS FINISHED WITH A S+N BACK UP DEVICE (SAME ITEM NUMBER). NO PATIENT INJURY OR SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794971 ↗
• InjuryApr 26, 2021Adverse 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) 2021, THE PATIENT PRESENTED AN INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REPLACE THE OXINIUM FEM HD 12/14 36MM -3, THE R3 20 DEG XLPE ACET LNR 36MM X 54MM AND THE SYN POR PLUS HA SO STEM SZ 12. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bacterial Infection

  MAUDE report 11722570 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED, UPON AN X-RAY FOLLOW-UP FROM A PLATED PERI PROSTHETIC FRACTURE, A SUBSIDENCE WAS REVEALED. ALTHOUGH STABLE, IT WAS DECIDED TO PERFORM A REVISION SURGERY TO REPLACE HEAD AND LINER. A GREAT RESULT WAS ACHIEVED.

  Patient problems: Insufficient Information

  MAUDE report 11573380 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS SCHEDULED TO POTENTIALLY REMOVE AND REPLACE ACETABULAR CUP AND LINER DUE TO SUSPECTED LOOSENING DUE TO LYSIS. UPON INSPECTION THE CUP WAS WELL FIXED AND A CYST WAS FOUND UNDER A SECTION OF THE CUP. THIS WAS EXCISED AND BONE GRAFT PLACED THROUGH THE HOLE IN THE CUP. A NEW LINER AND FEMORAL HEAD WERE PUT IN PLACE AND THE WOUND CLOSED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Cyst(s)

  MAUDE report 11095661 ↗
• MalfunctionDec 16, 2020Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SET UP/ INSPECTION THE R3 20 DEG XLPE ACET LNR 36MM X 54MM WAS FOUND NOT FITTING INTO THE ACETABULUM. THERE WAS NO DELAY. PROCEDURE CONCLUDED WITH A S&N BACK UP DEVICE. NO INJURIES REPORTED AT THIS TIME. 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 11020485 ↗
• InjuryOct 19, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING A THR PROCEDURE AFTER IMPLANTING THE CORRESPONDING 54 20 DEG XLPE LINER, AS PER SURGICAL TECHNIQUE. WHEN TRIAL REDUCTION WAS PERFORMED, IT WAS NOTED THAT THE LINER HAD MOVED INSIDE THE CUP AS IF IT WAS UNDERSIZED FOR THE SHELL COMPONENT (ROTATED AS WELL AS SUBSIDED WITHIN THE SHELL). OTHER 54 20 DEG LINER WAS OPENED AND USED AS PER SURGICAL TECHNIQUE WITHOUT ISSUE. A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES WAS REPORTED. NO REPORT OF PATIENT INJURY OR HARM WAS RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10697238 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A HIP REPLACEMENT, THE PATIENT APPEARED TO HAVE A POSSIBLE INFECTION. A REVISION SURGERY WAS PERFORMED TO WASH OUT THE JOINT AND EXCHANGE THE R3 20 DEG XLPE ACET LINER 36MM X 54MM. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 10428880 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASHOUT OF HIP AND EXCHANGE XLPE LINER AND OXINIUM HEAD DUE TO INFECTION. PRIMARY HIP REPLACEMENT DATE: (B)(6) 2020. NO REPORT REQUESTED BY SURGEON. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 10258134 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TOTAL HIP REPLACEMENT WAS PERFORMED ON 2016 USING R3/CPCS TO TREAT NECK OF FEMUR FRACTURE IN OF A FEMALE PATIENT BORN IN (B)(6). IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED SEVERAL TIMES OVER THE PAST 4 YEARS. DURING THE REVISION OPERATION, SURGEON NOTED THAT THE FEMORAL HEAD WAS SCRATCHED, AND APPEARED TO BE DISLOCATING POSTERIOR, AND THAT THE FEMORAL STEM WAS SLIGHTLY RE-TROVERTED. SURGEON NOTED THAT THIS WAS MOST LIKELY THE REASON FOR THE DISLOCATION. DURING REVISION SURGERY, THE FEMORAL HEAD, FEMORAL STEM, AND CUP LINER WERE REMOVED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Joint Dislocation

  MAUDE report 10209572 ↗

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.