R3 71335756Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 03596010598356), received between Sep 22, 2017 and Aug 22, 2024 — classified as 28 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 31 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 THR SURGERY, HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A LARGE SURFACE HEMATOMA AND POSSIBLE JOINT INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE R3 20 DEGREE XLPE ACETABULAR LINER 36MM ID X OD 56MM AND THE 36 MM OXINIUM FEMORAL HEAD MEMPHIS WERE EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hematoma; Medical device site infection

  MAUDE report 20042632 ↗
• InjuryMar 21, 2024Adverse 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) 2022, THE PATIENT EXPERIENCED INSTABILITY AND MULTIPLE DISLOCATIONS. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A R3 20 DEG XLPE ACET LNR 36MM X 56MM AND A COCR 12/14 FEM HEAD 36MM +12 WERE EXCHANGED. DESPITE THESE INTERVENTIONS, SUFFICIENT STABILITY WAS NOT ACHIEVED. HOWEVER, AFTER EXCHANGING A CPCS COCR PRIM SO 12/14 SZ 3 FOR A HIGHER OFFSET, SMALLER-SIZED STEM, LENGTH, AND STABILITY IMPROVED, RESULTING IN A STABLE HIP JOINT. THE CURRENT HEALTH STATUS OF THE PATIENT IS RECOVERING WELL.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 18952102 ↗
• InjuryMar 15, 2024Adverse 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 AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, DURING WHICH A R3 20 DEG XLPE ACET LNR 36MM X 56MM WAS EXCHANGED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 18913717 ↗
• MalfunctionMar 1, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE PLACING THE R3 3 HOLE ACET SHELL 56MM AND R3 20 DEG XLPE ACET LNR 36MM X 56MM, THE IMPLANTS FAILED TO BE FIXED AND LOCKED. SURGEON TRIED SEVERAL TIMES, BUT IT WAS NOT POSSIBLE TO POSITION THE MENTIONED COMPONENTS. THE PROCEDURE WAS RESUMED, AFTER A DELAY GREATER THAN 30 MIN, WITH S+N BACK-UP DEVICES. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18822477 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2023 THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED THROUGH REVISION SURGERY ON (B)(6) 2023, IN WHICH THE HIP WAS WASHED-OUT, AND OXINIUM FEM HD 12/14 36 MM -3 AND R3 20 DEG XLPE ACET LNR 36MM X 56MM WERE REMOVED AND REPLACED. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 16908381 ↗
• InjuryMay 8, 2023Fracture; Biocompatibility; Device Dislodged or Dislocated; Fracture; Biocompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER UNDERGOING R3-THA SURGERY ON (B)(6) 2018, THE PATIENT EXPERIENCED PAIN AND A SQUEAKING NOISE IN THE SURGICAL AREA. STEROID SHOTS WERE PRESCRIBED TO EASE THE PAIN. THIS SYMPTOM PERSISTED FOR TWO YEARS, ALONG WITH BURNING AND SENSITIVITY IN HER LEG AND HIP, FOR WHICH OPIOIDS WERE RECOMMENDED. ON (B)(6) 2022, THE PATIENT CONSULTED THESE SYMPTOMS WITH A DIFFERENT SURGEON, WHO INDICATED SHE HAD METAL SHAVINGS AND SHATTERING IN HER LEG. ON (B)(6) 2022, A REVISION SURGERY WAS CONDUCTED IN ORDER TO REPLACE THE SOCKET. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Burning Sensation; Implant Pain; Insufficient Information; Metal Related Pathology

  MAUDE report 16887786 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR ON 25-MAY-2022, THE PATIENT EXPERIENCED INFECTION. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXCHANGED THE R3 20 DEG XLPE ACET LNR 36MM X 56MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14848050 ↗
• InjuryMar 30, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED LINER AND FEMORAL HEAD DISLOCATION. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2020. THIS IS THE SECOND REVISION SURGERY AFTER IMPLANTATION DUE TO THE SAME CAUSE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 13956407 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) LEGAL, IT WAS REPORTED THAT, AFTER A FIRST REVISION SURGERY OF THE RIGHT THA PERFORMED ON (B)(6) 2015, WERE THE LINER AND FEMORAL HEAD WERE EXCHANGED, THE PLAINTIFF EXPERIENCED A FIRST HIP DISLOCATION ON (B)(6) 2016 TREATED WITH PAIN MEDICATION, AND A SECOND HIP DISLOCATION ON (B)(6) 2016. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 TO TREAT THIS ADVERSE EVENT. DURING THE SURGERY THE CUP WAS REINFORCED WITH A 20MM LONG SCREW AND THE FEMORAL HEAD AND LINER WERE EXPLANTED AND EXCHANGED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12519841 ↗
• InjurySep 21, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT, AFTER A THR SURGERY, ONE SYN POR FEM COMP SZ 13, ONE R3 3 HOLE ACET SHELL 56MM, ONE OXINIUM FEM HD 12/14 36 MM -3, AND ONE R3 20 DEG XLPE ACET LNR 36MM X 56MM WERE ASSOCIATED WITH A POST-OPERATIVE REACTION (PAIN, INFECTION AND UNHEALED INCISION). THIS HAPPENED AFTER USE IN PATIENT. THE ISSUE WAS RESOLVED WITH A REVISION SURGERY, IN WHICH THE SURGEON REMOVED ALL THE IMPLANTS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Impaired Healing; Pain; Unspecified Infection

  MAUDE report 12511046 ↗
• InjuryAug 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR ON (B)(6) 2009 A REVISION SURGERY WITH AN IRRIGATION AND DEBRIDEMENT HAS BEEN PERFORMED ON (B)(6) 2021 DUE TO A SUSPECTED INFECTION. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12295401 ↗
• InjuryJul 5, 2021Adverse 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 ON (B)(6) 2021, THE PATIENT EXPERIENCED POST OPERATIVE WOUND INFECTION THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021. A R3 20 DEG XLPE ACET LNR 36MM X 56MM (CASE (B)(4)) AND OXINIUM FEM HD 12/14 36 MM-3 (CASE (B)(4)) WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 12119140 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR, PERFORMED ON (B)(6) 2021, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXPLANT THE 20 DEGREES XLPE ACET LNEER36MM X 56MM ((B)(4)) AND COCR 12/14 FEM HEAD 36MM +0 ((B)(4)) DUE TO SUSPECTED INFECTION. PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12087430 ↗
• InjuryMar 10, 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 2019, THE PATIENT EXPERIENCED A DISLOCATION WHILE SQUATTING DOWN AND LEANING TO HIS FAR RIGHT TO REACH FOR POWER SOCKET. THEN, CONTINUED TO EXPERIENCE SUBSEQUENT DISLOCATIONS. PATIENT UNDERWENT REVISION SURGERY TO REMOVE 20 DEG XLPE ACET LNR ((B)(4)) AND OXINIUM FEM HD ((B)(4)) AND REPLACE WITH CONSTRAINED LINER AND NEW FEMORAL HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 11449956 ↗
• MalfunctionOct 20, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED DURING THE PROCEDURE THR THAT THE R3 LINER WOULD NOT SEAT IN THE SHELL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY AND WITH A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10708441 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED BECAUSE THE PATIENT PRESENTED A CHRONIC INFECTION IN THE RIGHT HIP. 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: Unspecified Infection

  MAUDE report 10681851 ↗
• MalfunctionJul 16, 2020Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING THR SURGERY, THE R3 20 DEGREES XLPE ACETABULAR LINER 36MM X 56MM DID NOT LOCK INTO PLACE IN THE R3 SHELL. THE PROCEDURE WAS FINISHED USING A SMITH AND NEPHEW BACK UP DEVICE, WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES, AND NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283605 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE R3/POLAR CONSTRUCT WAS IMPLANTED ON TUESDAY (B)(6) 2020 WAS BROUGHT BACK TO THEATRE FOR A REVISION DUE TO DISLOCATION. IT WAS FOUND THAT THE XLPE LINER WAS NOT LOCKED INTO THE CUP. THE PATIENT UNDERWENT A MANIPULATION UNDER ANAESTHETIC ON THURSDAY (B)(6) TO RELOCATE THE HIP, THEN REVISION SURGERY ON FRIDAY (B)(6) AS THE HIP WAS STILL DISLOCATING. A NEW LINER AND HEAD WERE IMPLANTED. THE NEW LINER SEEMED TO ENGAGE IN THE CUP WELL.

  Patient problems: Injury; Joint Dislocation; Subluxation

  MAUDE report 10281500 ↗
• InjuryJul 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE R3/POLAR CONSTRUCT WAS IMPLANTED ON TUESDAY (B)(6) 2020 WAS BROUGHT BACK TO THEATRE FOR A REVISION DUE TO DISLOCATION. IT WAS FOUND THAT THE XLPE LINER WAS NOT LOCKED INTO THE CUP. THE PATIENT UNDERWENT A MANIPULATION UNDER ANAESTHETIC ON THURSDAY (B)(6) TO RELOCATE THE HIP, THEN REVISION SURGERY ON FRIDAY (B)(6) AS THE HIP WAS STILL DISLOCATING. A NEW LINER AND HEAD WERE IMPLANTED. THE NEW LINER SEEMED TO ENGAGE IN THE CUP WELL.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 10281492 ↗
• InjuryDec 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  *US LEGAL*IT WAS REPORTED THAT THE PATIENT PRESENTED PAIN PROBLEMS ASSOCIATED WITH A TOTAL HIP REPLACEMENT. A REVISION SURGERY WAS PERFORMED TO EXPLANT THE HEAD AND THE LINER.

  Patient problems: Pain

  MAUDE report 9507386 ↗
• InjuryNov 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  US LEGAL: IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A EMPERION STEM FRACTURE. INTRAOPERATIVELY IT WAS FOUND THAT THE PATIENT WAS INFECTED, ALL THE IMPLANTS WERE REMOVED AND REPLACED WITH COMPETITOR DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 9311448 ↗
• InjuryOct 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2012 PRIMARY LEFT HIP REPLACEMENT WAS PERFORMED AND IN (B)(6) 2017, PATIENT BEGAN HAVING WORSENING LEFT HIP PAIN. ON (B)(6) 2018, A REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS AND PATIENT DISCOMFORT DUE TO A DISLOCATION THAT OCCURRED DAYS AFTER PRIMARY SURGERY, BLACK FLUID WAS ENCOUNTERED IN THE JOINT AND ALL DEVICES WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 9258505 ↗
• InjuryOct 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2012 PRIMARY LEFT HIP REPLACEMENT WAS PERFORMED AND ON (B)(6) 2012 PATIENT WAS DISCHARGED FROM EMERGENCY ROOM DUE TO HIP DISLOCATION AND A CLOSED REDUCTION WAS PERFORMED. DATE OF THE DISLOCATION IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 9258504 ↗
• InjuryOct 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A SURGERY WAS PERFORMED FOR THE REPOSITION OF THE ACETABULAR LINER DUE TO DISLOCATION.

  Patient problems: Injury

  MAUDE report 9164263 ↗
• InjuryMay 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT FELL AND HAS DISLOCATED HIP THREE TIMES NOW, RIGHT HIP WAS RELOCATED EACH TIME. REVISION SURGERY WAS PERFORMED TO CHANGE LINER AND FEMORAL HEAD.

  Patient problems: Injury

  MAUDE report 8661080 ↗

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-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.
• 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.