BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE 36MM

    MDR report key: 6525571 · Received April 27, 2017

    Report

    Report Number
    0001825034-2017-02833
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    November 21, 2016
    Report Date
    November 6, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    PAO
    PMA / PMN Number
    PK080642
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 113654, COMP PRIMARY STEM 14MM STD, LOT # 629590; CATALOG #: 115330, COMP RVRS SHDR GLEN BSPLT+HA, LOT # 094170; CATALOG #: 115381, COMP RVS CNTRL SCR 6.5X25MM ST, LOT # 892000; CATALOG #: 118001, VERSA-DIAL/COMP TI STD TAPER, LOT # 152020; CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 71794257; CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 704710; CATALOG #: 180503, COMP LOCKING SCREW 4.75X30MM, LOT # 324680; CATALOG #: 180505, COMP LOCKING SCREW 4.75X40MM, LOT # 805240; CATALOG #: 405889, COMP RVS 2.7MM DIA DRL, LOT # 313090; CATALOG #: 405883, COMP RVS 3.2MM DRL, LOT # 049280; CATALOG #: 405800, COMP REV SHLDR 9 IN STEINMANN, LOT # 520640; CATALOG #: 32-486265, 1/8 QUICK REL DRL STERILE 2PK, LOT # 963270; CATALOG #: 110004347, SIG GLEN CT GD/BONE MODEL SET, LOT # 902510. CUSTOMER HAS NOT INDICATED WHETHER OR NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-02836, 02833, 02890, 02885.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING REPORT IS SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT WAS NOT ABLE TO BE CONFIRMED. NO PRODUCT WAS RECEIVED FOR EVALUATION. THE INITIAL OPERATION NOTES IDENTIFIED NO ISSUES AND STATED THAT THE IMPLANT WAS STABLE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE REPORTED IMPLANTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL REVERSE SHOULDER ARTHROPLASTY REVISION APPROXIMATELY EIGHTEEN MONTHS POST-IMPLANTATION DUE TO INSTABILITY AND RECURRENT DISLOCATIONS. THE GLENOSPHERE, HUMERAL TRAY, AND HUMERAL BEARING WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308650 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE 36MM PROSTHESIS, SHOULDER PAO BIOMET ORTHOPEDICS N/A 318690

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R