R3 ACETABULAR 71335552Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 03596010598240), received between Oct 27, 2017 and Mar 30, 2026 — classified as 1 death, 29 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).

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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Biocompatibility

  IT WAS REPORTED THAT, AFTER A BILATERAL THA SURGERY PERFORMED ON (B)(6) 2012, THE PLAINTIFF HAD CLINICAL FINDINGS CONSISTENT WITH METALOSIS/TRUNIONOSIS DUE TO MODULAR COMPONENT. A RIGHT REVISION SURGERY WAS SCHEDULED FOR (B)(6) 2026. IT IS UNKNOWN WHICH IMPLANTS WERE REMOVED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Metal Related Pathology

  MAUDE report 24736623 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT WAS DEEMED TO BE "INFECTED" PER THE SURGEON. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2025, IN WHICH ONE (1) SYN POR FEM COMP SZ 14, ONE (1) R3 3 HOLE ACET SHELL 52MM, ONE (1) R3 20 DEG XLPE ACET LNR 36MM X 52MM, ONE (1) OXINIUM FEM HD 12/14 36 MM +0 AND ONE (1) REF SPHER HEAD SCREW 25MM WERE REMOVED. THE PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Unspecified Infection

  MAUDE report 24114870 ↗
• InjuryOct 12, 2025Degraded; Biocompatibility; Degraded; Biocompatibility

  IT WAS REPORTED THAT, AFTER THE PATIENT UNDERWENT A RIGHT R3 THR WITH ANTHOLOGY ON (B)(6) 2017 DUE TO AN ADVANCED AVASCULAR NECROSIS WITH EARLY COLLAPSE, IN 2025 RADIOGRAPHIC FINDINGS DISCOVERED THAT THERE WAS SIGNIFICANT RIGHT HIP JOINT DESTRUCTION. COBALT AND CHROMIUM WERE NORMAL. THE PATIENT WAS ALSO EXPERIENCING DISABLING PAIN AND FUNCTIONAL DISABILITY; SYMPTOMS WERE WORSE WITH AMBULATION AND ACTIVITIES. A PSEUDOTUMOR WAS FOUND ON THE RIGHT HIP. SCAN SHOWED SIGNIFICANT ANTEVERSION OF HIP CUP WITH NOTCHING WEAR IN THE FEMORAL NECK ON THE ACETABULAR CUP. CONSERVATIVE TREATMENT WITH NSAIDS AND ACTIVITY MODIFICATION HAD BEEN USED WITH NO RESULT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 AND METALLOSIS WAS NOTICED. A GRAY PURULENT GELATINOUS FLUID CAME OUT OF THE HIP JOINT AND WAS ASPIRATED AND SENT FOR CULTURE AND COBALT AND CHROMIUM QUANTITATIVE ANALYSIS. THE MASS FOUND WAS FILLED MOSTLY WITH THE SAME GRAY SLUDGE FOUND IN THE HIP CAPSULE. INSPECTION OF THE HIP FOUND THAT THERE WAS SIGNIFICANT WEAR OF THE POSTERIOR INFERIOR ASPECT OF THE CUP AND POLY LINER. THE CUP WAS SIGNIFICANTLY ANTEVERTED COMPARED TO HIS ANATOMIC ACETABULAR POSITION. THERE WAS 1-2MM OF WEAR INTO THE POST

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 23275071 ↗
• InjuryJan 20, 2025Adverse 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) 2023, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6)2024, IN WHICH ONE (1) R3 3 HOLE ACET SHELL 52MM, ONE (1) ANTHOLOGY SO POR PL HA SZ 1, ONE (1) OXINIUM FEM HD 12/14 32MM -3, ONE (1) R3 0 DEG XLPE ACET LNR 32MM X 52MM, AND TWO (2) REF SPHER HEAD SCREW 20MM WERE EXPLANTED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Medical device site infection

  MAUDE report 21191251 ↗
• InjuryDec 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE R3 3 HOLE ACET SHELL 52MM WAS NOTICED TO BE MISPOSITIONED AND AT RISK OF DISLOCATING. X-RAYS POST-OP SHOWED THE CUP TO BE TOO OPEN AND THE HEAD STARTING TO MIGRATE SUPERIORLY A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024, IN WHICH THE CUP SIZE WAS REAMED UP FROM A 52MM TO A 54MM. THE PATIENT'S HIP IS NOW STABLE.

  Patient problems: Failure of Implant

  MAUDE report 20851177 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA ON (B)(6) 2020 AND AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2020, PATIENT REQUIRED A TWO-STAGE REVISION SURGERY ON (B)(6) 2021 AND (B)(6) 2021 DUE TO INFECTION OF INTERNAL RIGHT HIP PROSTHESIS. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19554556 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA ON (B)(6) 2020, PATIENT REQUIRED READMISSION FOR AN IRRIGATION AND DEBRIDEMENT PROCEDURE ON (B)(6) 2020 DUE TO INFECTION AND INFLAMMATORY REACTION OF INTERNAL RIGHT HIP PROSTHESIS. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19554543 ↗
• InjuryJun 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A THA ON (B)(6) 2020, DUE TO UNILATERAL PRIMARY OSTEOARTHRITIS ON THE RIGHT HIP; PATIENT SUSTAINED AN UNSPECIFIED ADVERSE EVENT THAT REQUIRED REVISION SURGERY ON (B)(6) 2021. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19549105 ↗
• InjurySep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A FIRST REVISION THA HAD BEEN PERFORMED ON (B)(6) 2023 ((B)(4)) DUE TO MULTIPLE DISLOCATIONS OF THE RIGHT HIP, THE PATIENT CONTINUED TO EXPERIENCE DISLOCATIONS OF THE RIGHT HIP; 3 TO 4 DISLOCATIONS HAD OCCURRED AFTER THIS FIRST REVISION. THIS CONDITION WAS TREATED VIA A SECOND REVISION SURGERY ON (B)(6) 2023 DURING WHICH A R3 3 HOLE ACET SHELL 52MM, TWO S+N CANCELLOUS SCREWS, AN UNKNOWN ACETABULAR LINER, AND AN UNKNOWN FEMORAL HEAD WERE EXPLANTED AND REPLACED WITH A SERF IMPLANTS. ORIGINALLY, S+N DEVICES WERE PLANNED TO HAVE BEEN IMPLANTED DURING THIS SECOND REVISION, BUT THE INSTRUMENTS AND IMPLANTS WERE NOT READILY AVAILABLE DUE TO S+N EXITING THE MARKET IN THE COUNTRY OF OCCURRENCE. IT WAS REPORTED THAT THE PATIENT IS CURRENTLY DOING FINE.

  Patient problems: Joint Dislocation

  MAUDE report 17764965 ↗
• InjuryJul 5, 2023Adverse 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) 2019, THE PATIENT EXPERIENCED A CAPSULITIS ON THE RIGHT HIP ON APRIL 2021. THIS ADVERSE EVENT WAS TREATED WITH A CAPSULAR DEBRIDEMENT AND REMOVAL OF HETEROTOPIC OSSIFICATION ON (B)(6) 2021. THE PATIENT'S CURRENT HEALTH STATUS IS RECOVERED.

  Patient problems: Extraskeletal ossification; Inflammation; Joint Laxity

  MAUDE report 17254505 ↗
• InjuryJan 26, 2023Adverse 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 4-AUG-2020 TO ADDRESS END STAGE HIP ARTHRITIS WITH HYPERTROPHIC OSTEOPHYTE FORMATION, SUBCHONDRAL SCLEROSIS, DEGENERATIVE CYSTS AND JOINT SUBLUXATION, THE PATIENT REQUIRED A HIP INJECTION AT ONE (1) YEAR VISIT FOLLOW UP FOR HIP TROCHANTERIC BURSITIS. THE OUTCOME OF THE PATIENT IS NOT KNOWN. THIS INCIDENT WAS NOTICED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Inflammation

  MAUDE report 16246554 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED AN PERIPROSTHETIC JOINT INFECTION ON (B)(6) 2022. THIS ADVERSE EVENT WAS TREATED BY MEDICATION AND DEBRIDEMENT. CURRENT HEALTH STATUS OF PATIENT IS RECOVERING AND RESOLVING.

  Patient problems: Unspecified Infection

  MAUDE report 14990220 ↗
• InjuryMay 21, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER RIGHT R3-THA WAS PERFORMED ON (B)(6) 2010 DUE TO RIGHT SEVERE OSTEOARTHRITIS, THE PATIENT EXPERIENCED DEGENERATIVE CHANGES AND MILD SYNOVIAL HYPERPLASIA. THIS ADVERSE EVENT WAS TREATED WITH A REVISIONS SURGERY ON (B)(6) 2021. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Hyperplasia; Metal Related Pathology

  MAUDE report 14466161 ↗
• DeathApr 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A BILATERAL THR SURGERY PERFORMED (ONLY ONE IS FROM SMITH AND NEPHEW) ON (B)(6) 2010, THE CLINICAL SUBJECT PASSED AWAY ON (B)(6) 2020. THE CAUSE OF DEATH IS UNKNOWN. FURTHER INFORMATION IS NOT AVAILABLE AT THE TIME.

  Patient problems: Insufficient Information

  MAUDE report 14068225 ↗
• InjurySep 23, 2021Osseointegration Problem; Osseointegration Problem

  ''(B)(6) LEGAL'': BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER A PRIMARY R3-THA CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S RIGHT HIP ON (B)(6) 2010, THE PLAINTIFF EXPERIENCED METALLOSIS, PSEUDOTUMOR FORMATION, AN INFLAMMATORY PROCESS CONSISTENT WITH ALVAL LESION AND LOOSENING OF THE ACETABULAR CUP IMPLANT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT; THE BHR MODULAR HEAD 40MM, R3 ACETABULAR LINER CO-CR AND R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL 52MM WERE EXPLANTED. THE PLAINTIFF WAS TAKEN TO RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Failure of Implant; Foreign Body Reaction; Metal Related Pathology

  MAUDE report 12519321 ↗
• InjuryAug 9, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER A THA, (DATE UNKNOWN), A REVISION SURGERY WAS PERFORMED FOR RE-POSITIONING ON (B)(6) 2021. 3 HOLE ACETABULAR SHELL 52MM AND 20 DEGREE XLPE ACETABULAR LINER 36MM INNER DIAMETER X OUTER DIAMETER 52MM WERE EXTRACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297885 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA PERFORMED IN (B)(6) 2011, AND A MOTORCYCLE ACCIDENT IN (B)(6) 2012, THE PATIENT EXPERIENCED PAIN AROUND THE HIP. PHYSICIAN CONFIRMED ECCHYMOSIS, HOWEVER IT WAS INDICATED THAT THE HIP WAS IN GOOD POSITION AND NO INTERVENTION WAS PERFORMED. THE PATIENT CONTINUES TO HAVE PAIN, SO HE WAS TREATED WITH STEROID INJECTION AND PHYSIOTHERAPY SINCE 2012 DUE TO PAIN, HETEROTROPHIC OSSIFICATION AND TROCHANTERIC BURSITIS. NO OTHER COMPLICATION WERE REPORTED.

  Patient problems: Ecchymosis; Extraskeletal ossification; Pain

  MAUDE report 11947980 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, 6 MOTHS AFTER A REVISION SURGERY PERFORMED ON (B)(6) 2013 (COVERED UNDER (B)(4)), THE PATIENT REPORTED INCREASING PAIN. THE PATIENT WAS TREATED WITH PHYSICAL THERAPY AND STEROID INJECTIONS, WITH NO SUCCESS. RADIOGRAPHIC IMAGING REVEALED THAT THE COMPONENTS ARE WELL FIXED AND THAT THE PATIENT HAD HETEROTROPHIC OSSIFICATION. THE PHYSICIAN IS CONCERNED THAT THE LOWER EXTREMITY PAIN IS COMING FROM THE PATIENT¿S BACK. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 11947641 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT SUFFERED FROM PAIN IN THE HIP, WHICH WAS TREATED WITH UNSPECIFIED MEDICATION AND IS ONGOING. READMISSION OF THE PATIENT TO THE HOSPITAL WAS REQUIRED ON (B)(6) 2015. HIP WAS NEVER REVISED. THE PRIMARY SURGERY WAS ON (B)(6) 2011 FOR OSTEOARTHRITIS.

  Patient problems: Implant Pain

  MAUDE report 11240510 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO-STAGES REVISION SURGERY WAS PERFORMED TWO YEARS AFTER PRIMARY PROCEDURE DUE TO LOOSENING AND INFECTION WITH PLACEMENT OF ANTIBIOTIC SPACERS.

  Patient problems: Failure of Implant; Injury; Osteolysis; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 10551907 ↗
• InjuryJul 16, 2020Adverse 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, THE PATIENT EXPERIENCED PAIN. THE ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Arthralgia

  MAUDE report 10284271 ↗
• InjuryJun 30, 2020Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT, AFTER AN R3-THA SURGERY HAD BEEN PERFORMED IN THE LEFT HIP, THE PATIENT EXPERIENCED PROSTHETIC JOINT INFECTION, FAILED LEFT HIP REPLACEMENT, PERONEAL NERVE PALSY RESULTING IN FOOTDROP, PERIPROSTHETIC FRACTURE AT THE LEVEL OF THE DISTAL ASPECT OF THE STUMP. A REVISION SURGERY WAS PERFORMED TO TREAT THE ADVERSE EVENT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bacterial Infection; Hip Fracture

  MAUDE report 10216034 ↗
• InjuryMay 15, 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 THE PATIENT WAS HEARING A SQUEAKING NOISE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Injury

  MAUDE report 10063069 ↗
• 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 9413676 ↗
• InjuryMar 11, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  AFTER THR, THE SCREW WAS PASSED BY THE ACETABULAR CUP. NO DELAY REPORTED, NO DEVICE BACKUP REQUIRED.

  Patient problems: Injury

  MAUDE report 8409099 ↗