BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE SHOULDER SYSTEM PRIMARY STEM

    MDR report key: 7238814 · Received February 2, 2018

    Report

    Report Number
    0001825034-2018-00468
    Event Type
    Injury
    Date Received
    February 2, 2018
    Report Date
    March 29, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW UP REPORT IS BEING SUBMITTED TO REPORT ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF X-RAYS AND MEDICAL RECORDS. PHYSICAL THERAPY NOTES IMPLY THAT PATIENT WAS AGGRESSIVE WITH THERAPY AND REPEATEDLY REMINDED TO FOLLOW POST-OP PROTOCOLS. X-RAY REPORT FINDINGS INCLUDE: GENERALIZED REGIONS OF LUCENCY NOTED IN THE GREATER AND LESSER TUBERCLES AS WELL AS LIKELY IN THE GLENOID. THIS IS NOT SHARPLY DEMARCATED/PERIPROSTHETIC BUT APPEARS GENERALIZED IN THIS REGION. MAY SUGGEST STRESS SHIELDING/BONE RESORPTION AND CAN CONTRIBUTE TO PAIN. QUESTIONABLE JOINT BODIES/SYNOVITIS. ALSO THERE IS SUSPECTED CALCIFIC TENDINITIS, ANOTHER CAUSE OF PAIN. FINALLY, WIDENED AC JOINT CAN ALSO BE RELATED TO DISTAL CLAVICLE OSTEOLYSIS WHICH CAN BE RELATED TO PRIOR TRAUMA AND MAY BE A SOURCE OF PAIN IF NOT CHRONIC. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT WAS DUE TO PATIENT NON-COMPLIANCE WITH POST-OPERATIVE PHYSICAL THERAPY PLAN. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 00466, 0001825034 - 2018 - 00467, 0001825034 - 2018 - 00469, 0001825034 - 2018 - 00470. CONCOMITANT PRODUCT(S): A 113956 LG HYBRID GLENOID BASE 4MM LOT 305190. PT-113950 PT HYBRID GLEN POST REGENEREX LOT 112860. A 113063 VERSA-DIAL 54X21X64 HUM HEAD LOT 779770. A 118001 VERSA-DIAL/COMP TI STD TAPER LOT 225610. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT RIGHT SHOULDER PROCEDURE AND SUBSEQUENTLY IS EXPERIENCING MORE PAIN THAN EXPECTED, RANGE OF MOTION IS BETTER BUT PAINFUL AND WEAKNESS IN THE SHOULDER, SPECIFIC TO THE DELTOID MUSCLE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80684 COMPREHENSIVE SHOULDER SYSTEM PRIMARY STEM PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD ZIMMER BIOMET, INC. N/A 257150

    Patients

    Seq Age Sex Outcome Treatment
    1 Other