BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G7 PPS LTD ACET SHELL 58G

    MDR report key: 6967978 · Received October 23, 2017

    Report

    Report Number
    0001825034-2017-09022
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    September 28, 2017
    Report Date
    October 25, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    PK121874
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. ACETABULAR SHELL WAS RETURNED AND EVALUATED AGAINST THE COMPLAINT. THE SHELL IS ASSEMBLED WITH INSERTER. THE RIM OF THE SHELL IS SCUFFED AND DINGED. SCRATCHES WERE FOUND ON THE INNER RADIUS AROUND THE SIZE ETCHING OF THE SHELL. A GENERIC HEX KEY WAS USED IN AN ATTEMPT TO REMOVE THE SHELL. THE SHELL AND INSERTER COULD NOT BE DISASSEMBLED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO RELATED DEVIATIONS/ ANOMALIES WERE IDENTIFIED THAT AFFECT THE REPORTED EVENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 110003451, G7 STR MODULAR SHELL INSERTER, 970150, 010002736, G7 BALL HEX DRVR FOR INSR HNDL, 486661. (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-09023, 0001825034-2017-09024.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE CUP WOULD NOT UNLOCK, AND THE HANDLE WOULD NOT DETACH CAUSING THE BALL HEX DRIVER TO FRACTURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE CUP WOULD NOT UNLOCK, AND THE HANDLE WOULD NOT DETACH CAUSING THE BALL HEX DRIVER TO FRACTURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748573 G7 PPS LTD ACET SHELL 58G PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 3976980

    Patients

    Seq Age Sex Outcome Treatment
    1