BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING

    MDR report key: 6646071 · Received June 16, 2017

    Report

    Report Number
    0001825034-2017-04072
    Event Type
    Injury
    Date Received
    June 16, 2017
    Date of Event
    May 16, 2017
    Report Date
    June 21, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK113069
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS NOT BEEN INDICATED BY THE CUSTOMER WHETHER THE DEVICES CAN BE RETURNED FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT DEVICES: COMPREHENSIVE REVERSE ARCOMXL HUMERAL BEARING CATALOG #: XL-115363 LOT #: 398080, COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM GLENOID COMPONENT WITH F.A.S.T. GUIDES CATALOG #: 110027734 LOT #: 640210, COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM MINI TAPER ADAPTOR CATALOG #: 110031378 LOT #: 640220, COMPREHENSIVE REVERSE FIXED LOCKING SCREW CATALOG #: 180555 LOT #: 480630, COMPREHENSIVE REVERSE FIXED LOCKING SCREW CATALOG #: 180552 LOT #: 072060, COMPREHENSIVE REVERSE FIXED LOCKING SCREW CATALOG #: 180554 LOT #: 095430, COMPREHENSIVE REVERSE FIXED LOCKING SCREW CATALOG #: 180555 LOT #: 030200, COMPREHENSIVE REVERSE MINI HUMERAL STEM CATALOG #: 113633 LOT #: 563970, COMPREHENSIVE REVERSE GLENOSPHERE CATALOG #: 115310 LOT #: 896030, COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM DRILL CATALOG #: 110028045 LOT #: 612310, COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM DRILL CATALOG #: 110028045 LOT #: 612310, COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM DRILL CATALOG #: 110028045 LOT #: 612310, COMPREHENSIVE INSTRUMENTATION 3.2MM CENTRAL SCREW DRILL CATALOG #: 405883 LOT #: 872730, COMPREHENSIVE INSTRUMENTATION 2.7MM CENTRAL SCREW DRILL CATALOG #: 405889 LOT #: 431830. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-04073).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT REQUIRED A WASHOUT AND EXCHANGE OF THE POLYETHYLENE BEARING AND HUMERAL TRAY APPROXIMATELY TWENTY-FOUR DAYS (24) FOLLOWING SHOULDER ARTHROPLASTY, WITH APPROXIMATE ONSET OF TWENTY-TWO (22) DAYS POST-OPERATIVELY, DUE TO THE DEVELOPMENT OF INFECTION. THE SURGEON DOES NOT PLAN TO FURTHER REVISE THE PATIENT AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION, BUT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427884 COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 059630

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R