BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R3 MULTI HOLE ACETABULAR SHELL 58MM

    MDR report key: 12639099 · Received October 15, 2021

    Report

    Report Number
    1020279-2021-07580
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    August 5, 2020
    Report Date
    November 22, 2021
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MBL
    UDI-DI
    00885556022214
    PMA / PMN Number
    K092386
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE, USED IN TREATMENT, WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, THE REVISION OPERATIVE REPORT INDICATED MICROMOTION OF THE ACETABULAR SHELL AND THE VERTICAL POSITION AND INADEQUATE ANTEVERSION. IT IS UNKNOWN IF THE POSITION OF THE ACETABULAR CUP WAS A MIGRATION SINCE IMPLANTATION AND IF LED TO ACCELERATED WEAR AND THE REPORTED PAIN AND ELEVATED SERUM METAL ION LEVELS AND THE INTRAOPERATIVE FINDINGS OF CLOUDY STRAW COLORED JOINT FLUID, BLACK METALLOSIS, OSTEOLYSIS AND MICROMOTION OF THE SHELL. BASED ON THE INFORMATION PROVIDED, THE CLINICAL ROOT CAUSE OF THE REPORTED CLINICAL REACTIONS CANNOT BE CONFIRMED. IT CANNOT BE CONCLUDED THAT THE REPORTED CLINICAL REACTIONS WERE ASSOCIATED WITH A MALPERFORMANCE OF THE IMPLANT OR IMPLANT FAILURE. THE PATIENT IMPACT BEYOND THE PAIN, REVISION, AND EXPECTED TRANSIENT POST-OP CONVALESCENCE PERIOD CANNOT BE DETERMINED. NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH. A REVIEW OF THE RISK MANAGEMENT FILE AND INSTRUCTIONS FOR USE DOCUMENTS REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. SOME POTENTIAL PROBABLE CAUSES FOR THIS EVENT COULD INCLUDE DAMAGED PRODUCT, IMPLANT CORROSION, WEAR, INFLAMMATION, TRAUMATIC INJURY, ADVERSE REACTION, ABNORMAL MOTION OVER TIME, BONE DEGENERATION, FIT/SIZING ISSUE, LACK OF INGROWTH, AND/OR PATIENT CONDITION. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR 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 · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    US LEGAL MDL: IT WAS REPORTED THAT AFTER A LEFT R3-THA CONSTRUCT WAS IMPLANTED ON (B)(6) 2018, PLAINTIFF EXPERIENCED OSTEOLYSIS WITH LOOSENING ACETABULAR COMPONENT, PSEUDOTUMOR AND ELEVATED COBALT AND CHROMIUM LEVELS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THESE ADVERSE EVENTS. DURING THE SURGERY LARGE AMOUNT OF CLOUDY STRAW-COLORED JOINT FLUID EMANATED FROM THE INCISION, THE TRUNNION WAS INSPECTED AND NOTED TO DEMONSTRATE BLACK METALLOSIS AND OSTEOLYSIS NEAR THE ACETABULAR COMPONENT AND FEMORAL COMPONENT WAS NOTICED. THE CUP, HEAD, LINER, AND SLEEVE WERE EXPLANTED AND REPLACE. THE STEM WAS WELL FIXED, SO IT WAS CONSERVED. PATIENT OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538919 R3 MULTI HOLE ACETABULAR SHELL 58MM PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS MBL SMITH & NEPHEW, INC. 71338668 09KM09823 00885556022214

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Hospitalization| R| O 71356007-ANTHOLOGY SO POROUS SIZE 7| 74222200-MODULAR SLEEVE {} PLUS 0MM 12/14| 71356007-ANTHOLOGY SO POROUS SIZE 7| 74222200-MODULAR SLEEVE {} PLUS 0MM 12/14