BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HEAD

    MDR report key: 8487088 · Received April 5, 2019

    Report

    Report Number
    0001825034-2019-01596
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    March 14, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICE WAS RETURNED FOR REVIEW. MEDICAL RECORDS WERE REVIEWED WITH NO COMPLICATIONS NOTED. X-RAY REVIEW INDICATES POSSIBLE POLY WEAR. DHR WAS UNABLE TO BE REVIEWED WITHOUT PART/LOT CODE COMBINATION. ROOT CAUSE IS UNDETERMINED. 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 INFORMATION AVAILABLE AT THE TIME OF THIS REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 12-162609 - INTEGRAL STEM ¿ 734140; 31-472005 ¿ VISION PULLER BEARING ¿ 937390; 135254 ¿ VISION RINGLOC SHELL ¿ 045260; 11-105904 ¿ VISION RINGLOC LINER ¿ 736400; 103533 ¿ LOW PROFILE SCREW ¿ 201961; 103530 ¿ LOW PROFILE SCREW ¿ 101185. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE HOSPITAL DID NOT APPROVE OF RETURN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2019 - 01597.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 20 YEARS POST IMPLANTATION DUE TO PAIN AND LEG LENGTH DISCREPANCY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280017 UNKNOWN HEAD PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R