BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP RVRS 25MM BSPLT HA+ADPTR

    MDR report key: 6951611 · Received October 16, 2017

    Report

    Report Number
    0001825034-2017-08778
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    June 1, 2015
    Report Date
    October 16, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWS
    PMA / PMN Number
    PK120121
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PN: 113655 COMP PRIMARY STEM 15MM STD LOT: 808760, PN: 115370 COMP RVS TRAY CO 44MM LOT: 538280, PN: XL-115366 COMP RVS TRAY CO 44MM LOT: 538280, PN XL-115365 ARCOM XL 44-36 RTNV+3 HMRL BRG LOT 526330, PN 115375 COMP RVS TRAY +5MM CO 44MM LOT 484290, PN 180509 COMP NON-LCKNG SCREW 4.75X25MM LOT 852610, PN 180507 COMP NON-LCKNG SCREW 4.75X15MM LOT 023860, PN 115380 COMP NON-LCKNG SCREW 4.75X15MM LOT 750050, PN 180508 COMP NON-LCKNG SCREW 4.75X20MM LOT 852580. PRODUCT WAS NOT RETURNED TO ZIMMER BIOMET. FIRST REVISION: ROOT CAUSE ATTRIBUTED TO PATIENT FALL. SECOND REVISION: RELAYED BY THE PER: THE COMPLAINT DESCRIPTION AND INVESTIGATION FINDINGS CAN ONLY INDICATE THAT A POOR FIXATION OF THE TAPER ADAPTER TO THE BASEPLATE OCCURRED. ALTHOUGH THE FIRST TAPER DIMENSION WAS FOUND TO BE OUT OF SPECIFICATION IT CAN BE ATTRIBUTED TO THE MECHANICAL DAMAGED PRESENT AT THE TAPER OPENING. THE SALES REPRESENTATIVE INDICATED THAT NO TRAUMA WAS IDENTIFIED BY THE PATIENT DURING THE SECOND DISASSOCIATION EVENT. THE IFU WARNS "DISASSOCIATIONS OF MODULAR COMPONENTS HAVE BEEN REPORTED. FAILURE TO PROPERLY ALIGN AND COMPLETELY SEAT THE COMPONENTS TOGETHER CAN LEAD TO DISASSOCIATION". THE BASEPLATE TAPERS ARE 100% CHECKED DURING MANUFACTURING AND AFTER POROUS COATING. IT IS REASONABLE TO STATE THE COMPONENTS LEFT BIOMET CONFORMING THE DESIGN SPECIFICATIONS. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THESE ITEMS. PN: 010000589 LN: 041180; PN: 010000589 LN: 041180; PN: 118000-00 LN: 627490; PN: 118000-00 LN: 627490: REVIEW OF DEVICE HISTORY RECORDS FOUND THESE UNITS WERE RELEASED TO DISTRIBUTION WITH NO DEVIATIONS OR ANOMALIES.PN: 118000-00 LN: 571830: REVIEW OF DEVICE HISTORY RECORDS FOUND AN UNRELATED DEVIATION DURING THE MANUFACTURING PROCESS. THE NONCONFORMANCE WAS THAT ONE PIECE HAD NO ETCH AND WAS REWORKED AND TRANSFERRED TO LOT 662450. PN: 115326 LN: 496380: REVIEW OF DEVICE HISTORY RECORDS FOUND UNRELATED DEVIATIONS DURING THE MANUFACTURING PROCESS. THE FIRST NONCONFORMANCE WAS ONE PIECE HAD A PARTICLE IN THE LOWER RIGHT CORNER OF THE PACKAGING. THE PIECE WAS REPACKAGED AND ACCEPTED. THE SECOND NONCONFORMANCE WAS THAT SIX PIECES HAD A NON CRITICAL COSMETIC DISCREPANCY THAT DIDN'T EFFECT THE FUNCTION. PN: 115316 LN: 578400: REVIEW OF DEVICE HISTORY RECORDS FOUND AN UNRELATED DEVIATION DURING THE MANUFACTURING PROCESS. THE NONCONFORMANCE WAS THAT ONCE PIECE HAD A NON CRITICAL COSMETIC DISCREPANCY THAT DIDN'T EFFECT THE FUNCTION. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY ON (B)(6) 2013. SUBSEQUENTLY, PATIENT WAS REVISED ON (B)(6) 2013 DUE TO THE GLENOSPHERE DISASSOCIATING FROM BASEPLATE AFTER A PATIENT FALL. THE BASEPLATE, GLENOSPHERE, HUMERAL BEARING AND HUMERAL TRAY WERE REMOVED AND REPLACED. PATIENT UNDERWENT A FURTHER REVISION PROCEDURE ON (B)(6) 2015 DUE TO THE GLENOSPHERE DISASSOCIATING FROM THE BASEPLATE. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACER MOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730479 COMP RVRS 25MM BSPLT HA+ADPTR PROTHESIS SHOULDER KWS ZIMMER BIOMET, INC. NI 041180

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention