BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS SHDR GLEN BSPLT +HA

    MDR report key: 6828564 · Received August 29, 2017

    Report

    Report Number
    0001825034-2017-06871
    Event Type
    Injury
    Date Received
    August 29, 2017
    Report Date
    February 6, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: COMP PRIMARY STEM 8MM STD PART # 113648 LOT # 985870. COMP RVS HMRL TI TRAY 44MM PART # 115340 LOT # 228430. COMP RVRS SHLDR GLNSP STD 36MM PART # 115310 LOT # 239030. ARCOM XL 44-36 STD HMRL BRNG PART # XL-115363 LOT # 853780. VERSA-DIAL/COMP TI STD TAPER PR ADAPTOR PART # 118001 LOT # 362020. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 06872, 0001825034 - 2017 - 06873, 0001825034 - 2017 - 06874, 0001825034 - 2017 - 06875, 0001825034 - 2017 - 06876. IT IS UNKNOWN IF THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT OF INFORMATION RECEIVED AND REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT RECEIVED A COMPREHENSIVE REVERSE SHOULDER 5 1/2 YEARS AGO. IT HAS BEEN FURTHER REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN TO FIND MORE INFORMATION MADE BUT NO MORE INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607453 COMP RVRS SHDR GLEN BSPLT +HA PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 629650

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other