BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT 12/14 SIZE 2 COCR EXT

    MDR report key: 7822304 · Received August 28, 2018

    Report

    Report Number
    0002648920-2018-00660
    Event Type
    Injury
    Date Received
    August 28, 2018
    Date of Event
    March 22, 2017
    Report Date
    June 4, 2019
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    PMA / PMN Number
    PK960658
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UDI #: (B)(4). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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, DUE TO UNKNOWN PRODUCT LOCATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4). CONCOMITANT MEDICAL PRODUCTS: 00801802202, FEMORAL HEAD +0X22MM DIA, 63474807, 00801102020, ALLEN PLUG HDPE/BASO4 10C/20FL, 63433554, C05CC44, DUAL MOBILITY ADES CMNTD 44MM, 48815230, 05PE2244, D-MOB ADES INSERT 22.2MM SZ44, 48815400, 61971001, ANTIBIOTIC SIMPLEX TOBRAMYCIN (SINGLE PACK), 033/040/, 3325020, DEPUY CMW 2 BONE CEMENT WITH GENTAMICIN 20G FAST SET/, 8208113/. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN THE (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920 - 2018 - 00659.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION DUE TO INFECTION 1 MONTH POST IMPLANTATION. CULTURES FROM THE INFECTION ARE UNKNOWN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666043 CPT 12/14 SIZE 2 COCR EXT HIP PROSTHESIS JDI ZIMMER MANUFACTURING B.V. N/A 63506049

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R