BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL CUP - 40MM DIA X 4MM THK

    MDR report key: 15886607 · Received November 30, 2022

    Report

    Report Number
    0008031020-2022-00663
    Event Type
    Injury
    Date Received
    November 30, 2022
    Date of Event
    October 6, 2022
    Report Date
    January 19, 2023
    Manufacturer
    STRYKER GMBH
    Product Code
    KWS
    UDI-DI
    07613327098389
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE INSPECTION REVEALED THE FOLLOWING: THE IDENTIFICATION OF THE HUMERAL CUP - 40MM DIA X 4MM THK COULD BE CONFIRMED BASED ON THE CATALOG # AND THE LOT # MARKED. THE IMPLANT LOOKS RELATIVELY NEW WITH ONLY SMALL SCRATCHES AND WEAR MARKS DUE TO NORMAL USAGE. IT WAS NOT POSSIBLE TO DETERMINE IF METALLIC PARTICLES WERE CREATED. IT WAS NOT POSSIBLE TO CONFIRM THE REPORTED METALLOSIS, AS NOT ENOUGH INFORMATION WAS PROVIDED IN THIS CASE. FURTHERMORE, AS INDICATED BY MEDICAL EXPERTS, "METALLOSIS IS ABOUT THE TYPE-IV IMMUNE RESPONSE TO THE ACCUMULATION OF METAL PARTICLES WITHIN TISSUES. THERE ARE CASES OF EARLY ARTHROPLASTY FAILURE DUE TO METALLOSIS, YET THESE PATIENTS USUALLY DO WELL INITIALLY AND START TO GET PAIN AND JOINT STIFFNESS AFTER MONTHS, LEADING TO REVISION WITHIN 2 YEARS.". HOWEVER, THE REPORTED METALLOSIS WAS OBSERVED AFTER 6 WEEKS OF IMPLANTATION, A POST-SURGICAL LAPSE OF TIME MUCH SHORTER THAN WHAT IS USUALLY OBSERVED FOR SUCH RESPONSE. THIS GIVES FURTHER INDICATION OF THE LACK OF EVIDENCE POINTING TOWARDS METALLOSIS AND THE IMPOSSIBILITY TO CONFIRM THE REPORTED EVENT. BASED ON THE INVESTIGATION, NO PROBLEM COULD BE DETECTED ON THE HUMERAL CUP AND THE LINK WITH A POSSIBLE METALLOSIS COULD NOT BE ESTABLISHED. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF MORE INFORMATION IS PROVIDED, THE CASE WILL BE REASSESSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT HAD THEIR SHOULDER STEM REMOVED 6 WEEKS POST OPP DUE TO METALLOSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT HAD THEIR SHOULDER STEM REMOVED 6 WEEKS POST OPP DUE TO METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2526587 HUMERAL CUP - 40MM DIA X 4MM THK PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS STRYKER GMBH 5570-4004 KM80DR 07613327098389

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention