BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE STANDARD TAPER ADAPTOR

    MDR report key: 7352070 · Received March 20, 2018

    Report

    Report Number
    0001825034-2018-01780
    Event Type
    Injury
    Date Received
    March 20, 2018
    Date of Event
    February 21, 2018
    Report Date
    April 19, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBF
    PMA / PMN Number
    PK060716
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. MEDICAL PRODUCT: COMPREHENSIVE REVERSE CENTRAL SCREW CATALOG#: 115396 LOT#: 765410. E1 STANDARD HUMERAL BEARING CATALOG#: EP-115393 LOT#: 211910 . COMPREHENSIVE REVERSE TRAY CATALOG#: 115370 LOT#: 641920 . COMPREHENSIVE REVERSE GLENOSPHERE 36MM CATALOG#: 115310 LOT#: 341180. COMPREHENSIVE CONVERTIBLE GLENOID BASEPLATE, CATALOG#: PM0000797 LOT#: 419480. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 0

    DURING A SHOULDER REVISION PROCEDURE, THE TAPER ADAPTOR WOULD NOT SEAT IN THE CENTRAL SCREW HOLE OVER THE SCREW. A SHORTER SCREW WAS TRIED IN ITS PLACE, BUT THE ISSUE PERSISTED. THE CENTRAL SCREW WAS THEN REMOVED AND THE TAPER ADAPTOR SEATED. THE DEVICE WAS LEFT IMPLANTED WITHOUT A CENTRAL SCREW. NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: MFR#0001825034-2018-01781. CONCOMITANT PRODUCTS: COMP RVS CNTRL 6.5X30MM ST/RST PN115396 LN765410; E1 44-36 STD HMRL BRNG PNEP-115393 LN211910; COMP RVS TRAY CO 44MM PN115370 LN641920; COMP RVRS SHLDR GLNSP STD 36MM PN115310 LN341180. (B)(5). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT WAS IMPLANTED INTO THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. ROOT CAUSE REMAINS UNDETERMINED. 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

    DURING A SHOULDER REVISION PROCEDURE, THE TAPER ADAPTOR WOULD NOT SEAT IN THE CENTRAL SCREW HOLE OVER THE SCREW. A SHORTER SCREW WAS TRIED IN ITS PLACE, BUT THE ISSUE PERSISTED. THE CENTRAL SCREW WAS THEN REMOVED AND THE TAPER ADAPTOR FIT. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197579 COMPREHENSIVE STANDARD TAPER ADAPTOR PROSTHESIS, SHOULDER MBF ZIMMER BIOMET, INC. N/A 298810

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R