BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RINGLOC+ REPLACEMENT RING SZ21

    MDR report key: 6819812 · Received August 25, 2017

    Report

    Report Number
    0001825034-2017-06204
    Event Type
    Malfunction
    Date Received
    August 25, 2017
    Date of Event
    July 26, 2017
    Report Date
    January 9, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK070369
    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)(6). THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT: COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING, CATALOG#: 115370, LOT #: 327330. 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. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. THE LOCKING RING FROM ITEM NUMBER 115370, LOT NUMBER 327330 WAS RETURNED AND ITEM NUMBER 106021, LOT NUMBER 684850 WAS DISCARDED. 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.

    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
    602734 RINGLOC+ REPLACEMENT RING SZ21 PROSTHESIS, HIP LPH BIOMET ORTHOPEDICS N/A 684850

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR