BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 32/+3MM T1

    MDR report key: 6917361 · Received October 5, 2017

    Report

    Report Number
    3002806535-2017-00926
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    May 18, 2017
    Report Date
    March 21, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JDI
    PMA / PMN Number
    PK131684
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DATE OF BIRTH - PATIENT WAS BORN IN (B)(6). CONCOMITANT PRODUCTS: 110003619, G7 CERAMIC LINER, 3230050. 010000664, G7 PPS LTD ACET SHELL 54F, 3790818. 192013, ECHO POR FMRL NC 13X145MM, 751010. REPORT SOURCE, FOREIGN ¿ EVENTS OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. (B)(4). REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA CLINICAL OPERATIVE NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT SUFFERED FASCIA RUPTURE, AND A SURGICAL INTERVENTION, SUTURE OF THE FASCIA, WAS PERFORMED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698449 DELTA CER FEM HD 32/+3MM T1 PROSTHESIS, HIP JDI BIOMET UK LTD. N/A 2016021417

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R