R3 71332754Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03596010597991), received between Jun 1, 2017 and Mar 1, 2024 — classified as 16 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT, DURING A THR REVISION SURGERY, INTRAOPERATIVELY IT WAS NOTICED THAT THERE WAS NO PROPER EXCHANGE FOR THE REFLECTION SYSTEM. DUE TO A MISUNDERSTANDING IN THE CUSTOMER'S ORDER PLACED WITH SN, INSERTS WERE DELIVERED FOR THE R3 SYSTEM AND NOT FOR THE REFLECTION SYSTEM FOR THIS SURGERY. A PROPER EXCHANGE IMPLANT WAS DELIVERED FROM ANOTHER HOSPITAL DURING THE SURGERY, THE DURATION OF THE SURGERY WAS EXTENDED. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18816432 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY: (B)(6); SUBJECT: (B)(6); AE: 01 INFECTION. IT WAS REPORTED THAT, AFTER A THA SURGERY PERFORMED ON (B)(6) 2019, DUE TO THE DEVELOPED OF PERIPROSTHETIC JOINT INFECTION A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 FOR AN IRRIGATION DEBRIDEMENT AND THE EXTRACTION OF THE OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3 ((B)(6)) AND THE R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM ((B)(6)). THIS ADVERSE EVENT WAS RESOLVED AND PATIENT IS RECOVERED.

  Patient problems: Unspecified Infection

  MAUDE report 12537043 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6); AE: 01 INFECTION. IT WAS REPORTED THAT, AFTER A THA SURGERY PERFORMED ON (B)(6) 2019, DUE TO THE DEVELOPED OF PERIPROSTHETIC JOINT INFECTION A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 FOR AN IRRIGATION DEBRIDEMENT AND THE EXTRACTION OF THE OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3 (CASE (B)(4)) AND THE R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM (CASE (B)(4)). THIS ADVERSE EVENT WAS RESOLVED AND PATIENT IS RECOVERED.

  Patient problems: Unspecified Infection

  MAUDE report 12533982 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY PERFORMED ON (B)(6) 2019, DUE TO THE DEVELOPED OF PERIPROSTHETIC JOINT INFECTION OF STREPTOCOCCUS AGALACTIAE 2+, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 FOR AN IRRIGATION DEBRIDEMENT AND THE EXTRACTION OF THE OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3 AND THE R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM. ADDITIONALLY, THE PATIENT RECEIVED ANTIBIOTIC THERAPY TO CONTROL THE INFECTION. THIS ADVERSE EVENT WAS RESOLVED AND PATIENT IS RECOVERED, PATIENT DID NOT HAVE ANY PROBLEM WALKING AFTER THE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 12530550 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY PERFORMED ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 FOR AN IRRIGATION DEBRIDEMENT AND THE EXTRACTION OF THE OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM -3 AND THE R3 0 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 54MM DUE TO THE DEVELOPMENT OF PERIPROSTHETIC JOINT INFECTION OF METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS (MSSA). ADDITIONALLY, THE PATIENT RECEIVED ANTIBIOTIC THERAPY TO CONTROL THE INFECTION. THIS ADVERSE EVENT WAS RESOLVED AND PATIENT IS RECOVERED, PATIENT DID NOT HAVE ANY PROBLEM WALKING AFTER THE REVISION.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 12530466 ↗
• MalfunctionAug 5, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT, DURING THR SURGERY, A HAIR WAS FOUND INSIDE THE STERILE PACKAGE OF A R3 0 DEG XLPE ACET LNR 36MM X 54MM. 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 12285650 ↗
• InjuryMay 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR WAS PERFORMED ON (B)(6) 2017, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TTO REMOVED THE 0 DEG XLPE ACET LNR 36MM X 54MM ((B)(4)) AND OXINIUM FEM HD 12/14 36 MM +0 ((B)(4)) DUE TO DISLOCATION, AND REPLACED THEM WITH AN OR3O INSERT AND LINER WITH A 28MM +8 OXINIUM HEAD ON. NO PATIENT HARM BEYOND THE DESCRIBED EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 11908918 ↗
• InjuryApr 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR THAT HAD BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED LEAKING OF THE WOUND DUE TO STAPHYLOCOCCUS INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO ADDRESS THIS ADVERSE EVENT. THE SURGEON PERFORMED AN INCISION THROUGH THE PREVIOUS INCISION, WASHED THE HIP OUT AND TOOK PATHOLOGY SAMPLES. THE INITIAL PLAN WAS TO PERFORM A FEMORAL HEAD AND LINER EXCHANGE BUT WHEN THE SURGEON WAS USING A PUNCH TO GET THE FEMORAL HEAD OFF, IT KNOCKED THE FEMORAL STEM LOOSE. SO THE SURGEON NEEDED TO REPLACE THE STEM ALSO. NEW SN DEVICES WERE IMPLANTED. THE CURRENT STATUS OF PATIENT¿S HEALTH IS UNKNOWN. NEW IMPLANTS THAT WERE PUT IN: 71332754 LOT #20KM04471 ACETABULAR LINER. 71357107 LOT #20KM05452 ANTHOLOGY FEMORAL COMPONENT. 71343604 LOT #20MM11041.

  Patient problems: Bacterial Infection; Wound Dehiscence

  MAUDE report 11648421 ↗
• InjuryMar 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLAR3.HIP.PRO.2019.02; SUBJECT 12.012; AE 01. IT WAS REPORTED THAT AFTER A BILATERAL THA PERFORMED ON (B)(6) 2021, THE PATIENT SUFFERED FROM A DISLOCATION ON (B)(6) 2021. MANUAL REPOSITIONING WAS PERFORMED. THE CAUSAL RELATIONSHIP AND SEVERITY HAVE NOT BEEN DETERMINED AS OF TODAY.

  Patient problems: Joint Dislocation

  MAUDE report 11593541 ↗
• MalfunctionMar 14, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING A THR A SMALL HAIR WAS FOUND IN THE PACKAGING OF THE R3 0 DEG XLPE ACET LNR 36MM X 54MM. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478833 ↗
• MalfunctionFeb 3, 2021Fitting Problem; Incomplete or Inadequate Connection; Fitting Problem; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A THR, THE LINER WOULD NOT SEAT INTO CUP PROPERLY. OPENED A BACK-UP DEVICE AND IT SEATED FINE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11276788 ↗
• MalfunctionDec 6, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DESPITE SEVERAL ATTEMPTS, THE R3 LINER COULD NOT BE INSERTED IN THE CUP. A SECOND LINER (A S+N BACKUP DEVICE) FIT IN THE FIRST ATTEMPT. A SURGICAL DELAY OF 30 MIN OR LESS WAS REPORTED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10956323 ↗
• InjuryNov 4, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO CONSTANT DISLOCATIONS. THE SURGEON ATTEMPTED TO REPLACE THE LINER AND ADD 3 SCREWS AND A R3 LINER TO OBTAIN STABILITY BUT WAS NOT ACHIEVED. AFTER THIS THE CUP WAS REMOVED AND ALSO THE STEM. THE FINAL RESULT WAS SUCCESSFUL AND THE WOUND WAS CLOSED.

  Patient problems: Joint Dislocation

  MAUDE report 10788632 ↗
• InjuryMay 4, 2020Scratched Material; Scratched Material

  IT WAS REPORTED THAT DURING SURGERY, LINER (71332754) WAS IMPLANTED AND WHEN TRIAL HEAD (75100856) WAS DONE BEING USED TO MAKE SURGICAL ASSESSMENT OF LENGTH AND OFFSET, SCRATCHES WERE NOTICED ON LINER. SINCE NO BACKUP DEVICE WAS AVAILABLE, A LINER WITH DIFFERENT SIZE WAS USED TO COMPLETE THE PROCEDURE (71339554). ONCE THE STEM AND HEAD (71343200) WERE IMPLANTED, AS SURGEON WAS TRYING TO REMOVE THE HEAD, STEM AND HEAD WERE REMOVED AS ONE PIECE AND SCRATCHES WERE NOTICED ON THE OXINIUM HEAD. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE OF THE SAME SIZE FOR THE HEAD. A DELAY OF LESS THAN 1 HOUR WAS REPORTED.

  Patient problems: Injury

  MAUDE report 10022546 ↗
• InjuryApr 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT THR VIA THE POSTERIOR APPROACH USING ANTHOLOGY R3 CONSTRUCT. THE PATIENT PRESENTED LATE-ONSET INFECTION YEARS AFTER SURGERY. DR. DECIDED TO DO THE RIGHT SIDE FIRST STAGE REVISION THR, REMOVAL OF 36MM X 54MM R3 XLPE 0 DEGREE LINER WAS PERFORMED IN SITU ON (B)(6) 2020 AT (B)(6). FULL SECOND STAGE REVISION WILL BE PERFORMED ONCE INFECTION SUBSIDES.

  Patient problems: Unspecified Infection

  MAUDE report 9927415 ↗
• InjuryFeb 14, 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. PATIENT PRESENTED AN OOZED WOUND. AN AGGRESSIVE WASHOUT WAS PERFORMED. LINER AND HEAD WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9714980 ↗
• InjuryFeb 4, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO MOBILISATION OF THE STEM.

  Patient problems: Injury

  MAUDE report 9666694 ↗
• InjuryJun 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A REVISION SURGERY DUE TO DISLOCATION. THE DR VIA A DAA APPROACH WENT IN VIA PREVIOUS INCISION. INSPECTED THE TOTAL HIP, REMOVED HEAD AND LINER AS PER SURGICAL TECHNIQUE.

  Patient problems: Injury

  MAUDE report 8670184 ↗
• InjuryFeb 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A REVISION SURGERY WAS PERFORMED TO THE POLY AND A NEW POLY AND A NEW FEMORAL HEAD WERE IMPLANTED.

  Patient problems: Injury

  MAUDE report 8306216 ↗
• InjuryJan 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD PERSISTENT PAIN AFTER REVISION SURGERY AND AN INJECTION INTRO THE TROCHANTERIC BURSA WAS GIVEN TO RELIEF THE PAIN. ALSO, XRAYS WERE DONE TO DIAGNOSE THE REASON OF THE PAIN BUT NOTHING ABNORMAL WAS FOUND.

  Patient problems: Pain

  MAUDE report 8207403 ↗
• InjuryJun 1, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT UNDERWENT A REVISION SURGERY WITH EXCHANGE OF LINER TO A CONSTRAINED TYPE DUE TO SEVERAL DISLOCATIONS.

  Patient problems: Failure of Implant; Joint Dislocation

  MAUDE report 6604094 ↗

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.