BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER AND SHELL WITH PLASTIC BARRIER 36 MM I.D. 46 MM O.D.

    MDR report key: 10235046 · Received July 6, 2020

    Report

    Report Number
    0001822565-2020-02367
    Event Type
    Injury
    Date Received
    July 6, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 17, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDI
    UDI-DI
    00889024359468
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REVIEW OF THE STERILIZATION CERTIFICATE CONFIRMS THAT THE DEVICE WAS STERILIZED PER SPECIFICATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SINGLE-USE, STERILIZED DEVICES MANUFACTURED OR DISTRIBUTED BY ZIMMER BIOMET ARE STERILIZED IN ACCORDANCE WITH FDA REGULATIONS AND ISO STANDARDS TO A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THEREFORE, IT IS UNLIKELY THAT THE SPECIFIED DEVICE CAUSED ANY PATIENT INFECTION. 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 ADDITIONAL INFORMATION ON REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CONCOMITANT MEDICAL PRODUCTS: 650-0661, DELTA CERAMIC FEM HD 36/0MM, 2019020332. 51-101070, TPRLC 133 FP TYPE1 PPS HO 7.0, 6041877. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY APPROXIMATELY 1-MONTH POST IMPLANTATION DUE TO INFECTION. 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
    701338 LINER AND SHELL WITH PLASTIC BARRIER 36 MM I.D. 46 MM O.D. PROSTHESIS, HIP JDI ZIMMER BIOMET, INC. N/A 64014059 00889024359468

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.