BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ML/HD RNGLC FINN ACET HAP 52MM

    MDR report key: 5532894 · Received March 29, 2016

    Report

    Report Number
    3002806535-2016-00156
    Event Type
    Injury
    Date Received
    March 29, 2016
    Date of Event
    February 26, 2016
    Report Date
    June 1, 2016
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: DEVICE-TO-DEVICE INTERACTION TESTING. EXAMINATION OF THE RETURNED DEVICE AND DIMENSIONAL EVALUATION FOUND NO EVIDENCE OF PRODUCT NONCONFORMANCE. DURING THE EVALUATION, NO SIGNS OF DEFORMATION WERE NOTED AND THE DEVICE ATTACHED TO MATING COMPONENT WITHOUT DIFFICULTY. A CONCLUSIVE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    THIS USER FACILITY IS OUTSIDE OF THE UNITED STATES. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY. DEVICE AVAILABILITY - THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED BY BIOMET TO DATE. IN THE EVENT THAT THE DEVICE IS RECEIVED AND EVALUATED, A FOLLOW-UP REPORT WILL BE SEND TO THE FDA TO PROVIDE RESULTS. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K030055.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2016. DURING THE PROCEDURE AFTER THE SURGEON IMPACTED THE SHELL, THE LOCKING RING BECAME DISLODGED. THE SURGEON REMOVED THE CUP AND LOCKING RING AS IT WOULD NOT LOCK INTO PLACE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SHELL AND LOCKING RING COMPONENTS. DUE TO THE EVENT THERE WAS A TWENTY (20) MINUTE DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187865 ML/HD RNGLC FINN ACET HAP 52MM PROSTHESIS, HIP LPH BIOMET UK LTD. N/A 3628400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention