BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPT TYPE 1 TPR SLEVE 0MM

    MDR report key: 6629371 · Received June 9, 2017

    Report

    Report Number
    0001825034-2017-03565
    Event Type
    Injury
    Date Received
    June 9, 2017
    Date of Event
    March 24, 2016
    Report Date
    November 16, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: CER BIOLOXD OPTION HD 36MM/ PN 650-1057/ LN 132420, MLRY-HD POR FMRL 10X155MM/ PN 11-104110/ LN 397470, UNKNOWN CUP. 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: 0001825034-2017-03567, 0001825034-2017-03568, 0001825034-2017-03569.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE AS THERE IS NO FAILURE ALLEGED AGAINST THE DEVICE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CORRECTED: DESCRIBE EVENT OR PROBLEM, THE REVISION WAS ON LEFT HIP. 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 PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY EIGHT MONTHS POST IMPLANTATION DUE TO PATIENT ALLEGATIONS OF PAIN. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SECOND LEFT HIP REVISION APPROXIMATELY 8 MONTH POST THE FIRST REVISION SURGERY, DUE PAIN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412491 CER OPT TYPE 1 TPR SLEVE 0MM PROSTHESIS, HIP LZO BIOMET ORTHOPEDICS N/A 326490

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R