BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, PE WITH PEG, LARGE

    MDR report key: 4122470 · Received September 26, 2014

    Report

    Report Number
    1220246-2014-00173
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 1, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K083435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, 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 PART REMAINS IN THE PATIENT AND CANNOT BE 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. LOT NUMBER WAS NOT PROVIDED SO DEVICE HISTORY RECORD REVIEW CANNOT BE PERFORMED. FROM THE INFORMATION GIVEN AND WITHOUT DEVICE EVALUATION, IT IS UNKNOWN AT THIS POINT WHY THE GLENOID BECAME LOOSE AS STATED IN THE EVENT. THE MOST LIKELY CAUSE OF THIS EVENT IS FAILURE TO FOLLOW THE POST-OP REHAB PROTOCOL. THE DIRECTIONS FOR USE (DFU-0131G) STATES: POSTOPERATIVELY, UNTIL HEALING IS COMPLETE THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POSTOPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE IMPLANT. THE GLENOID COMPONENTS ARE INTENDED FOR CEMENTED FIXATION IN THE JOINT AND MUST ONLY BE USED WITH APPROPRIATE BONE CEMENT. ADVERSE EFFECTS: LOOSENING OF THE IMPLANT AS A RESULT OF CHANGED CONDITIONS IN LOAD TRANSFER, RESPECTIVELY, FATIGUE WEAR AND BREAKAGE OF THE CEMENT BED AND/OR TISSUE REACTION TO THE IMPLANT. LOOSENING IS FREQUENTLY A CONSEQUENCE OF ONE OF SEVERAL OF THE ABOVE RISK CONDITIONS, BUT CAN ALSO BE CAUSED BY INADEQUATE ANCHORING TECHNIQUE. WARNING: THE FOLLOWING OPERATIVE SITUATIONS MAY CAUSE PREMATURE LOOSENING AND COMPLICATIONS: EXTREME WEAKENING OF THE BONE STRUCTURE IN PREPARING THE BONE BED. UNSUITABLE SELECTION OF THE IMPLANT SIZE. INADEQUATE CLEANING OF THE BONE BED PRIOR TO IMPLANTATION; AND, EXCESSIVE USE OF FORCE IN PLACING OR FASTENING THE IMPLANT, PROVOKING SPLINTERING FRACTURES, OR CAUSING THE BONE TO TEAR. AN ARTIFICIAL IMPLANT IS SUBJECT TO WEAR AND/OR CAN LOOSEN OVER A PERIOD OF TIME. WEAR AND LOOSENING MAY MAKE IT NECESSARY TO RE-OPERATE ON AN ARTIFICIAL JOINT. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. PART REMAINS IN PATIENT.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT PATIENT CAN ONLY LIFT ARM ABOUT 60 TO 70 PERCENT, EXPERIENCING SEVERE PAIN DOWN THE BICEP AREA. PATIENT HAD A CT SCAN PERFORMED AND IT REVEALED THE GLENOID IS LOOSE. CONTRAST DYE FROM THE CT SCAN GOT UNDERNEATH THE GLENOID CONFIRMING A DIAGNOSIS THAT THE GLENOID WAS LOOSE. CASE: TOTAL SHOULDER REPLACEMENT. THIS IS THE PATIENT'S FOURTH SURGERY. FOLLOW UP WITH PATIENT: PATIENT STATED HE WAS TOLD THE PLASTIC PIECE THAT SITS ON THE GLENOID IS LOOSE AND NEEDS TO BE FIXED. HIS RANGE OF MOTION IS AT 65% AND HAS A FEW ISSUES SINCE HIS FIRST SURGERY. HE HAS HAD A TORN AC, SEPARATED SHOULDER (OLD FOOTBALL INJURY) TORN DELTOID AND A TORN BICEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601279 GLENOID, PE WITH PEG, LARGE PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other