BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE WITH TAPER ADAPTER

    MDR report key: 6642292 · Received June 14, 2017

    Report

    Report Number
    0001825034-2017-03958
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    May 24, 2016
    Report Date
    June 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS INITIALLY IMPLANTED ON (B)(6) 2016, HOWEVER WAS REMOVED AND REIMPLANTED ON (B)(6) 2016. CONCOMITANT MEDICAL PRODUCTS: CATALOG #: 115310, COMP RVRS SHLDR GLNSP STD 36MM, LOT # 529480, CATALOG #: 115395, COMP RVS CNTRL 6.5X25MM ST/NS, LOT # 161960, CATALOG #: 180550, COMP LK SCR 3.5HEX 4.75X15 ST, LOT # 6192920, CATALOG #: 180551, COMP LK SCR 3.5HEX 4.75X20 ST, LOT # 863450, CATALOG #: 180552, COMP LK SCR 3.5HEX 4.75X25 ST, LOT # 294240, CATALOG #: 113631, COMP PRIMARY STEM 11MM MINI M MINI, LOT # 253100, CATALOG #: 115370, COMP RVRS TRAY CO 44MM, LOT # 648630, CATALOG #: XL-115363, ARCOM XL 44-36 STD HMRL BRNG, LOT # 418390, CATALOG #: 32-486265, DRILL BIT 1/8 INCH DRILL QUICK RELEASE, LOT # 606690, CATALOG #: 405800, COMPREHENSIVE INSTRUMENTATION 2.7MM PERIPHERAL SCREW DRILL BIT, LOT # 804300, CATALOG #: 405800, COMPREHENSIVE INSTRUMENTATION SHOULDER STEINMANN THREADED TIP, LOT # 404890. THE CUSTOMER HAS NOT INDICATED WHETHER THE PRODUCT WILL BE RETURNED TO ZIMMER BIOMENT FOR INVESTIGATION OR NOT. ONCE THIS INFORMATION IS OBTAINED A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT, THIS IS MDR 2 OF 2; PLEASE SEE ASSOCIATED REPORT: 1825034-2016-04697.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF PROVIDED OPERATIVE NOTES. IT IS NOTED FROM FIRST REVISION OPERATIVE NOTES (SURGERY DATE, (B)(6) 2016) THAT "AT THIS POINT, OUR IMPLANTS ON THE BACK TABLE FROM OUR PREVIOUS SURGERY WERE CLEANED AND, DUE TO THE FACT THAT THERE WERE NO OBVIOUS FINDINGS TO THEM, THEY WERE REIMPLANTED WITHOUT DIFFICULTY, AND WE TRIED MULTIPLE TIMES TO TRY DISSOCIATE THE 2 PARTS. THIS WAS UNSUCCESSFUL" AND "THE GLENOSPHERE STAYED NICE AND STABLE." IT IS NOTED IN THE INSTRUCTIONS FOR USE: "DO NOT REUSE IMPLANTS. WHILE AN IMPLANT MAY APPEAR UNDAMAGED, PREVIOUS STRESS MAY HAVE CREATED IMPERFECTIONS THAT WOULD REDUCE THE SERVICE LIFE OF THE IMPLANT." 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. A DEFINITE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED HOWEVER REUSING THE DEVICES IS USE ERROR. A SUMMARY OF THE INVESTIGATION FINDINGS HAS NOT BEEN SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE DUE TO LEGAL ACTION IN PROGRESS. 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 PATIENT UNDERWENT A RIGHT SHOULDER ARTHROPLASTY REVISION APPROXIMATELY TWENTY-SIX (26) DAYS POST-OPERATIVELY DUE TO THE GLENOSPHERE TAPER DISASSOCIATING FROM THE GLENOID BASEPLATE. THE COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423130 COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE MINI BASEPLATE WITH TAPER ADAPTER PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 357480

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R