BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUMERAL STEM 9MM

    MDR report key: 1603375 · Received February 18, 2010

    Report

    Report Number
    1220246-2010-00024
    Event Type
    Injury
    Date Received
    February 18, 2010
    Date of Event
    January 26, 2010
    Report Date
    January 26, 2010
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K010124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP WITH THE REPORTER AND THE PATIENT PROVIDED ADDITIONAL INFORMATION THAT THE PATIENTS RIGHT SHOULDER WAS REPLACED WITH A TOTAL SHOULDER SYSTEM THAT WAS IMPLANTED IN (B) (6) 2004. IN (B) (6) 2004, THE ORIGINAL SURGEON REPLACED THE HUMERAL HEAD BECAUSE THE INITIAL ONE WAS THE WRONG SIZE. IN (B) (6) 2010, THE PATIENT WAS STRETCHING AND FELT AN ODD FEELING IN THE RIGHT SHOULDER. ON (B) (6) 2010, THE PATIENT HAD A SUBLUXATION REPAIR. DURING THE REPAIR SURGERY, IT WAS NOTED THAT THE BALL WAS BROKEN OFF AND THE ROD AND SOCKET WERE LOOSE. THE SURGEON REMOVED THE HUMERAL STEM AND HEAD AND REPLACED THEM WITH AN ANTIBIOTIC CEMENT SPACER. INFORMATION REGARDING THE PATIENT'S FUTURE PLANS FOR RE-IMPLANTATION WAS NOT PROVIDED. PATIENT'S DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE DEVICE WAS REQUESTED FOR EVALUATION BUT WAS NOT RETURNED; THEREFORE THE COMPLAINANT'S EVENT COULD NOT BE VERIFIED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. PART NUMBER CONFIRMATION WAS REQUESTED BUT NOT PROVIDED; THEREFORE AR-9100-09 WAS USED AS THE MOST LIKELY PART TO THIS COMPLAINT. A LOT NUMBER WAS ALSO REQUESTED BUT NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED APPROXIMATELY SIX YEARS POST OP. ACCORDING TO THE REPORTER THE PATIENT RECEIVED A TOTAL SHOULDER IN 2004. THE PATIENT RECENTLY COMPLAINED OF SUBLUXATION (DISLOCATION). DURING THE REVISION SURGERY ON (B) (6) 2010, THE SURGEON NOTICED THAT THE HEAD OF THE PROSTHESIS WAS SHEARED OFF. THE SURGEON REMOVED THE HEAD AND STEM AND REPLACED THEM WITH A CEMENT SPACER (TEMPORARILY REPLACES A TOTAL SHOULDER SYSTEM THAT HAS BEEN EXPLANTED). NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED AT THE TIME THIS EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMERAL STEM 9MM PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R HUMERAL HEAD 51/22 (LOT # UNKNOWN)