BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMP RVS TRAY CO 44MM

    MDR report key: 6817716 · Received August 24, 2017

    Report

    Report Number
    0001825034-2017-06709
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    July 26, 2017
    Report Date
    January 9, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK113069
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERAPY DATE - (B)(6) 2017. MEDICAL PRODUCT - RINGLOC+ REPLACEMENT RING SZ21 CATALOG # 106021, LOT # 684850. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPOTS WERE FILLED FOR THIS EVENT: 0001825034 - 2017 - 06204.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT:S RINGLOC+HIP SYSTEM REPLACEMENT RING, CATALOG#: 106021, LOT#: 684850 ARCOM XL HUMERAL BEARING, CATALOG#: XL-115363, LOT#: 935090. COMPREHENSIVE REVERSE SHOULDER GLENOSPHERE, CATALOG#: 115310, LOT#: 455910. COMPREHENSIVE LOCKING SCREW, CATALOG#: 180550, LOT#: 131120. COMPREHENSIVE LOCKING SCREW: CATALOG#: 180550, LOT#: 494290. COMPREHENSIVE LOCKING SCREW, CATALOG#: 180550, LOT#: 211660. COMPREHENSIVE LOCKING SCREW, CATALOG#: 180551, LOT#: 772110. COMPREHENSIVE REVERSE CENTRAL SCREW, CATALOG#: 115394, LOT#: 485450. COMPREHENSIVE PRIMARY MINI STEM: CATALOG#: 113629, LOT#: 392260. COMPREHENSIVE REVERSE BASEPLATE + ADAPTER, CATALOG#: 010000589, LOT#: 206570. COMPREHENSIVE REVERSE DRILL, CATALOG#: 405889, LOT#: 873170. COMPREHENSIVE REVERSE DRILL, CATALOG#: 405883, LOT#: 432500. COMPREHENSIVE REVERSE SHOULDER STEINMANN PIN, CATALOG#: 405800, LOT#: 820130. STEINMANN PIN, CATALOG#: 406669, LOT#: 063830. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. THE LOCKING RING FROM ITEM NUMBER 115370, LOT NUMBER 327330 WAS RETURNED AND ITEM NUMBER 106021, LOT NUMBER 684850 WAS DISCARDED. VISUAL INSPECTION IDENTIFIED THE LOCKING RING COMPONENT WAS RECEIVED BENT. 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. 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 TWO LOCKING RINGS WERE DAMAGED INTRAOPERATIVELY. NO COMPLICATIONS OR DELAYS REPORTED. NO FURTHER INFORMATION MADE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TOTAL SHOULDER ARTHROPLASTY, TWO LOCKING RINGS WERE DAMAGED INTRAOPERATIVELY WHILE TRYING TO ASSEMBLE THE HUMERAL BEARING TO THE TRAY. IN THE FIRST ATTEMPT, THE ASSEMBLY TOOL WAS NOT USED, HOWEVER, ON THE SECOND ATTEMPT WITH THE REPLACEMENT LOCKING RING THE TOOL WAS USED. IN BOTH CASES, THE LOCKING RING BENT. NO COMPLICATIONS OR DELAYS REPORTED. A NEW TRAY WAS OPENED AND UTILIZED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION MADE AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596560 COMP RVS TRAY CO 44MM PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 327330

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR