BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/H RADIAL SOLID/APX SHL 52MM

    MDR report key: 7118320 · Received December 14, 2017

    Report

    Report Number
    0001825034-2017-11015
    Event Type
    Injury
    Date Received
    December 14, 2017
    Date of Event
    December 12, 2011
    Report Date
    February 23, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    PK921181
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: EP-105933, EPOLY 32MM RLC LNR MROM SZ23, 900060. 51-104100, TPRLC 133 TYPE1 PPS HO 10.0, 2203578. 650-1056, CER BIOLOXD OPTION HD 32MM, 251280. 650-1064, CER OPTION TYPE 1 TPR SLEVE -6, 453080. CUSTOMER HAS BEEN 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2017 - 11016, 0001825034 - 2017 - 11017, 0001825034 - 2017 - 11210, 0001825034 - 2017 - 11211. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS ABLE TO BE CONFIRMED VIA OP NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT 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 · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LEFT LATERAL FEMORAL CUTANEOUS NERVE NEURECTOMY FOR TREATMENT OF MERALGIA PARESTHETICA WITH SEVERE BURNING PAIN POST LEFT TOTAL HIP ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT LATERAL FEMORAL CUTANEOUS NERVE NEURECTOMY FOR TREATMENT OF MERALGIA PARESTHETICA WITH SEVERE BURNING PAIN POST RIGHT TOTAL HIP ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897472 M/H RADIAL SOLID/APX SHL 52MM PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 090900

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R