BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G7 SCREW 6.5MM X 25MM

    MDR report key: 8300922 · Received February 4, 2019

    Report

    Report Number
    0001825034-2019-00424
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    July 18, 2014
    Report Date
    February 18, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    K121874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI: (B)(4). REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. OP NOTES WERE REVIEWED AND VERIFIED THAT THE PATIENT HAD UNDERWENT A REVISION DUE TO MIGRATION, ACETABULAR FAILURE OF INGROWTH, AND PERIPROSTHETIC ACETABULAR FRACTURE. THERE WAS A NOTE ABOUT A BROKEN SCREW BEING FOUND WHILE REMOVING THE LINER AND ACETABULAR COMPONENT. THE BROKEN SCREW FRAGMENT COULD NOT BE REMOVED AND THE HEAD OF THE SCREW WAS BURRED DOWN TO ALLOW FOR REAMING. THE DEVICE HISTORY RECORDS FOR ITEM # 010000998, LOT # 29822003 WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH NO DEVIATIONS AND/OR ANOMALIES THAT WOULD HAVE ATTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORDS FOR ITEM # 010000999, LOT # 2982204 WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH NO DEVIATIONS AND/OR ANOMALIES THAT WOULD HAVE ATTRIBUTED TO THE EVENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IT IS UNKNOWN WHICH SCREW WAS FRACTURED AND LEFT IN SITU. THE OTHER SCREW INFORMATION IS 010000999, G7 SCREW 6.5MM X 30MM, LOT 2982204. CONCOMITANT MEDICAL PRODUCTS: 010000663, G7 PPS LTD ACET SHELL 52E, LOT 3002716, 010000849, G7 NEUTRAL E1 LINER 32MM E, LOT 3081919, 163667, 32MM MOD HEAD COCR -6MM NECK, LOT 319760, UNKNOWN STEM. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2014-07734.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT¿S HIP WAS REVISED APPROXIMATELY 8 MONTHS POST IMPLANTATION DUE TO PAIN, DISCOMFORT, WITH SUPEROLATERAL SUBLUXATION ATTRIBUTED TO PERIPROSTHETIC ACETABULAR FRACTURE AND MIGRATION OF ACETABULAR COMPONENT. LACK OF BONEY INGROWTH WAS NOTED. A FRACTURED SCREW WAS UNABLE TO BE RETRIEVED AND WAS LEFT IN PATIENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93844 G7 SCREW 6.5MM X 25MM PROSTHESIS HIP JDI ZIMMER BIOMET, INC. N/A 2982203

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R