BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM COCR MOD HD -3MM

    MDR report key: 6694691 · Received July 7, 2017

    Report

    Report Number
    0001825034-2017-04676
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    June 10, 2016
    Report Date
    November 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JDI
    PMA / PMN Number
    PK032396
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT - TPRLC 133 FP TYPE1 PPS HO 14.0, CATALOG # 51-101140 LOT # 3639350, UNKNOWN LINER, UNKNOWN CUP. 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: 0001825034-2017-04591, 0001825034-2017-04687, 0001825034 -2017-04691.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT MEDICAL PRODUCT - 36 MM COCR MOD HD -3 MM, PART#11-363661 LOT#223210; G7 NEUTRAL ARCOMXL LNR 36 MM F, PART#010000741 LOT#3338476; G7 PPS LTD ACET SHELL 56F, PART#010000665 LOT#3565676; TPRLC 133 TYPE1 PPS SO 14.0, PART#51-103140 LOT#3639350. 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. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION(S) IS/ARE REQUIRED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALLEGED TO RIGHT HIP RADIATING GROIN PAIN POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473733 36MM COCR MOD HD -3MM PROSTHESIS, HIP JDI BIOMET ORTHOPEDICS N/A 223210

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other