PINNACLE 1217-45-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10603295010401), received between Jul 21, 2017 and Jun 17, 2026 — classified as 60 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loss of Osseointegration” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ENTIRE CONSTRUCT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED IN ITS POSITION. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD IMMEDIATELY AND THERE WAS NO HARM DONE TO THE PT. DOI: (B)(6) 2024. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25540727 ↗
• InjuryFeb 12, 2026Osseointegration Problem

  ADDITIONAL INFORMATION RECEIVED: A. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT. B. PLEASE CONFIRM IF THE FEMORAL HEAD AND ACETABULAR CUP FRACTURED OR IF THIS WAS AN ACETABULAR BONE FRACTURE. BONY FRACTURE, NOT IMPLANT.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Joint Laxity

  MAUDE report 24327023 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS INFECTED SO IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PUT IN. ORIGINAL IMPLANT DATE. (B)(6) 2025. EXPLANT DATE. (B)(6) 2025.

  Patient problems: Unspecified Infection

  MAUDE report 23647766 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR HIP REVISION - INFECTION DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 13 OCT 2025. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: COMPONENTS REMOVED (STEM, HEAD). DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 101854018. LOT NUMBER: 4442962. COMPONENT TYPE: STEM. DESCRIPTION: RECLAIM MONOBLOC REVISION STANDARD STEM 18 STANDARD OFFSET. CATALOG NUMBER: 473246028. LOT NUMBER: 4838000. COMPONENT TYPE: HEAD. DESCRIPTION: EMPHASYS 46 MM X 28 MM AOX MOBILE BEARING HEAD. CATALOG NUMBER: 472556046. LOT NUMBER: 4671538. COMPONENT TYPE: LINER. DESCRIPTION: EMPHASYS 56-58 MM X 46 MM DUAL MOBILITY LINER. CATALOG NUMBER: 471056300. LOT NUMBER: 4925729. COMPONENT TYPE: SHELL. DESCRIPTION: EMSYS SHL 3HOLE 56. CATALOG NUMBER: 121735500. LOT NUMBER: PU209417. COMPONENT TYPE: SCREW. DESCRIPTION: CANCELLOUS BONE SCREW 35MM. CATALOG NUMBER: 121745500. LOT NUMBER: PU216737. COMPONENT TYPE: SCREW. DESCRIPTION: CANCELLOUS BONE SCREW 45MM. CATALOG NUMBER: 136528310. LOT NUMBER: 4369950. COMPONENT TYPE: HEAD. DESCRIPTION: BIOLO

  Patient problems: Unspecified Infection

  MAUDE report 23523326 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2012, THE PATIENT RECEIVED A RIGHT ANTERIOR APPROACH TOTAL HIP ARTHROPLASTY TO ADDRESS RIGHT HIP OSTEOARTHRITIS. METAL ON METAL IMPLANTS WERE IMPLANTED. THERE WERE NO COMPLICATIONS. ON (B)(6) 2024, PATIENT'S RIGHT HIP WAS REVISED TO ADDRESS ALVAL PSEUDOTUMOR, METALLOSIS, OSSEUS BONE EROSIONS, AND OSTEOLYSIS. THE METAL INSERT AND HEAD WERE REPLACED WITH A DUAL MOBILITY LINER CONSTRUCT. THERE WERE NO COMPLICATIONS. ON (B)(6) 2024, THE PATIENT'S RIGHT HIP WAS REVISED AGAIN TO ADDRESS PURULENT WOUND DRAINAGE, POSSIBLE INFECTION VERSUS ALVAL LESION. CULTURES OBTAINED WERE INCONSISTENT WITH INFECTION, SO THE DIAGNOSIS LEANED IN FAVOR OF ALVAL, SUBSEQUENT TO THE PREVIOUS REVISION. SURGEON REVISED AND REPLACED THE FEMORAL HEAD AND THE DUAL MOBILITY METAL AND POLY LINERS, RETAINING THE ACETABULAR CUP AND FEMORAL STEM. AND EXTENSIVE IRRIGATION AND DEBRIDEMENT WERE PERFORMED. THERE WERE NO COMPLICATIONS. THIS REPORT CAPTURES THE REVISION PROCEDURE ON (B)(6) 2024. THE PREVIOUS REVISION IS CAPTURED ON RELATED COMPLAINT (B)(4). DOI: (B)(6) 2012. DOI: (B)(6) 2024. DOE: 10/23/2024.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Osteolysis; Pain; Pocket Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 22161440 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT ORIGINALLY HAD A HIP REPLACED IN (B)(6) 2024. THE PATIENT DEVELOPMENT AN INFECTION IN THE RIGHT HIP. ALL THE COMPONENTS WERE EXPLANTED AND REPLACED WITH A PROSTALAC STEM.

  Patient problems: Unspecified Infection

  MAUDE report 22084797 ↗
• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED. ALL COMPONENTS (EXCEPT CUP) WERE REMOVED AND NEW IMPLANTS WERE INSERTED AFTER IRRIGATION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21687101 ↗
• InjuryJan 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS REMOVED DUE TO INFECTION, SPACERS IMPLANTED, THERE WAS NO DELAY IN THE CASE AND THE PATIENT WAS NOT HARMED. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21129504 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PREVIOUSLY IMPLANTED COMPONENTS WERE ALL REMOVED DUE TO AN INFECTION IN THE PATIENT. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 20860627 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HER HIP REPLACED APPROXIMATELY 6 WEEKS AGO BY SURGEON AT THE HOSPITAL. THE SURGEON BROUGHT THE PATENT INTO SURGERY AND EXPLANTED ALL OF HER IMPLANTS AND IMPLANTED A PROSTALAC CONSTRUCT. NO DELAYS, NO ADVERSE EVENTS TO REPORT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19279371 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19020068 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP DISLOCATION AND WAS INFECTED. ALL ACETABULAR COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16930512 ↗
• InjuryDec 28, 2022Osseointegration Problem; Osseointegration Problem

  REVISION COMPLETED DUE TO LOOSENING OF CUP. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16059479 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT HAD AN INFECTION. THE IMPLANT IN QUESTION WILL BE REMOVED, AND A SPACER MOLD WILL BE INSERTED ON DATE UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2019. DOR: UNKNOWN. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 15931998 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, PATIENT REVISED DUE TO INFECTION. DOI: (B)(6) 2019; DOR: (B)(6) 2019 ; LEFT HIP 3RD COMPLAINT

  Patient problems: Unspecified Infection

  MAUDE report 15633097 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14565127 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Pain

  MAUDE report 12977635 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT HIP.

  Patient problems: Pain

  MAUDE report 12977575 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISED FOR INSTABILITY. NOTHING FURTHER TO REPORT. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 12953411 ↗
• InjuryOct 18, 2021Osseointegration Problem; Migration; Osseointegration Problem; Migration

  THE PATIENT WAS REVISED TO ADDRESS MIGRATION AND LOOSENING OF THE CUP AT THE BONE TO IMPLANT INTERFACE. CANCER PATIENT. CONVERTED TO TRI-FLANGE. PROXIMAL FEMUR AND SEGMENT REMOVED TO RE-ESTABLISH LEG LENGTH. DOI: (B)(6) 2018, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12646626 ↗
• MalfunctionJun 7, 2021Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping; Difficult to Open or Remove Packaging Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE OUTER POUCH OF IMPLANT DID NOT PEEL BACK/ APART APPROPRIATELY WHEN NURSE WAS OPENING, THEREFORE CONTAMINATING PRODUCT. NO SURGICAL DELAY. EVENT DATE: (B)(6) 2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11950570 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CAME INTO CLINIC FOR HIS TWO WEEK POST OP APPOINTMENT WITH A DRAINING SURGICAL WOUND. PLAN WAS TO WASH HIM OUT AND TAP ON COMPONENTS TO SEE IF THEY HAD TIME TO ADHERE TO THE BONE. SINCE THIS WAS ONLY TWO WEEKS OUT THE INTRAOP DECISION BY SURGEON WAS TO EXTRACT ALL COMPONENTS AND REVISE CUP TO A GRIPTION MULTI HOLE AND GO UP ONE SIZE ACTIS STEM FOLLOWING A PROPER IRRIGATION. DOI: (B)(6) 2020. DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 10549077 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR HIP OPERATED ON AT (B)(6) BY DR (B)(6) ON (B)(6) 2019. THIS WAS ALSO A REVISION CASE, BUT I AM NOT SURE OF WHEN THE ORIGINAL PROCEDURE DATE. IT WAS NOT IN THE OPERATIVE NOTES. REVISION WAS BEING DONE BY DR (B)(6) DUE TO PATIENT INSTABILITY. DR (B)(6) BELIEVED THE ACETABULAR COMPONENT WAS NOT POSITIONED PROPERLY AND NEEDED TO BE ADJUSTED. ALL OF THE IMPLANTS WERE REMOVED FROM THE ACETABULAR SIDE OF THE PATIENT, AND REPLACED WITH ZIMMER COMPONENTS. DR (B)(6) FELT THAT THE FEMORAL STEM WAS WELL FIXED AND OPTED TO LEAVE IT. ONCE THE ZIMMER CUP WAS INSERTED, A TRIAL REDUCTION WAS PERFORMED WITH OUR 40MM HEAD TRIAL. A 40MM +12 WAS FOUND TO BE SATISFACTORY AND IMPLANTED. CLOSING PROCESS BEGAN. DOI: (B)(6) 2019. DOR: (B)(6) 2020. AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10159592 ↗
• InjuryJun 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THEIR HIP OPERATED ON AT (B)(6) BY DR (B)(6) ON (B)(6) 2019. THIS WAS ALSO A REVISION CASE, BUT I AM NOT SURE OF WHEN THE ORIGINAL PROCEDURE DATE. IT WAS NOT IN THE OPERATIVE NOTES. REVISION WAS BEING DONE BY DR (B)(6). DUE TO PATIENT INSTABILITY. DR (B)(6) BELIEVED THE ACETABULAR COMPONENT WAS NOT POSITIONED PROPERLY AND NEEDED TO BE ADJUSTED. ALL OF THE IMPLANTS WERE REMOVED FROM THE ACETABULAR SIDE OF THE PATIENT, AND REPLACED WITH ZIMMER COMPONENTS. DR (B)(6) FELT THAT THE FEMORAL STEM WAS WELL FIXED AND OPTED TO LEAVE IT. ONCE THE ZIMMER CUP WAS INSERTED, A TRIAL REDUCTION WAS PERFORMED WITH OUR 40MM HEAD TRIAL. A 40MM +12 WAS FOUND TO BE SATISFACTORY AND IMPLANTED. CLOSING PROCESS BEGAN. DOI: (B)(6) 2019; DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10159582 ↗
• InjuryJun 11, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL LOOSENING OF ACETABULAR COMPONENTS AND AUGMENT AT BONE TO IMPLANT INTERFACE. DOI: (B)(6) 2015. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 10145675 ↗