BEUDAMED
    FDA Adverse Event Death Summary report: N

    R3 3 HOLE ACET SHELL MM48

    MDR report key: 17303107 · Received July 11, 2023

    Report

    Report Number
    1020279-2023-01444
    Event Type
    Death
    Date Received
    July 11, 2023
    Date of Event
    September 1, 2022
    Report Date
    August 7, 2023
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MRA
    UDI-DI
    03596010598226
    PMA / PMN Number
    PO30022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: GIVEN THE NATURE OF THE ALLEGED INCIDENT, THE DEVICES, COULD NOT BE RETURNED FOR EVALUATION. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, ALTHOUGH REQUESTED, NO RELEVANT SUPPORTING CLINICAL INFORMATION WAS PROVIDED TO ASSIST WITH THE CLINICAL INVESTIGATION SURROUNDING THE CIRCUMSTANCES OF THE PATIENT¿S DEATH. THERE IS NO CURRENT EVIDENCE THAT SUGGESTS A RELATIONSHIP BETWEEN THE IMPLANTED S&N DEVICES AND THE REPORTED DECEASE. THEREFORE, BASED ON INSUFFICIENT INFORMATION, A THOROUGH CLINICAL ASSESSMENT CANNOT BE PERFORMED AT THIS TIME. A REVIEW OF THE PRODUCTION ORDERS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBERS OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBERS BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICES. FOR THE SHELL, LINER AND FEMORAL HEAD, A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR TOTAL HIP SYSTEMS PROVIDES COMPLETE GUIDELINES OF INDICATIONS, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS AND POSSIBLE ADVERSE EFFECTS THAT MAY OCCUR PREOPERATIVE, DURING SURGERY OR POST OPERATIVE. FOR THE STEM, A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS REVEALED A LISTS OF SEVERAL POTENTIAL ADVERSE DEVICE EFFECTS FROM A HIP ARTHROPLASTY. BASED ON THE CLINICAL/MEDICAL EVALUATION CONCLUSIONS, THE RISK ASSESSMENT REVIEW WAS NOT PERFORMED AS THERE IS NO SUPPORTING INFORMATION PROVIDED AT THIS TIME THAT RELATES THE ALLEGED EVENT TO A FAILURE IN THE DEVICES. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THESE PRODUCTS AND EVENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCTS FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. NO DETAILS ABOUT THE MALFUNCTION OF THE DEVICES WERE PROVIDED, THEREFORE NO FACTORS THAT CAN CONTRIBUTE CAN BE DELINEATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: CASE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER A LEFT THR SURGERY WAS PERFORMED DUE TO OSTEOARTHRITIS ON (B)(6) 2022, IN WHICH A OXINIUM FEM HD 12/14 32MM -3, A POLARSTEM STEM LAT.TI/HA 4 NON-CEM, A R3 3 HOLE ACET SHELL MM48 AND A R3 0 DEG XLPE ACET LNR 32MM X 48MM WERE IMPLANTED, THE PATIENT DIED AROUND ON (B)(6) 2022. THE SPECIFIC DATE AND REASON OF THE PATIENT'S DEATH ARE UNKNOWN. THERE IS NO CURRENT EVIDENCE THAT SUGGESTS A RELATIONSHIP BETWEEN THE IMPLANTED DEVICES AND THE REPORTED DECEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250424 R3 3 HOLE ACET SHELL MM48 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE MRA SMITH & NEPHEW, INC. 71335548 21MW00036 03596010598226

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Female Death OXINIUM FEM HD 12/14 32MM -3, LOT#:21CM03448| POLARSTEM STEM LAT.TI/HA 4 NON-CEM, LOT#:B2015971| R3 0 DEG XLPE ACET LNR 32MM X 48MM, LOT#:21MM02517