BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO POR FMRL RED NC 9X125MM

    MDR report key: 8609139 · Received May 14, 2019

    Report

    Report Number
    0001825034-2019-02128
    Event Type
    Injury
    Date Received
    May 14, 2019
    Date of Event
    June 26, 2018
    Report Date
    May 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K070274
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001825034 - 2018 - 04310, 0001825034 - 2019 - 02128, 0001825034 - 2019 - 02127. REVIEW OF INVOICE HISTORY WAS UNABLE TO DETERMINE THE EXACT IDENTIFICATION OF THE DEVICE INVOLVED IN THE REPORTED EVENT. THIS REPORT IS BEING SUBMITTED FOR: LOT NUMBER ¿644330, EXPIRATION DATE ¿ JAN 28, 2022, DEVICE MANUFACTURE DATE - JAN 1, 2012, OR LOT NUMBER ¿ 730540, EXPIRATION DATE ¿ MAY 28, 2022, DEVICE MANUFACTURE DATE - MAY 1, 2012. CONCOMITANT MEDICAL PRODUCTS: ITEM_DESCRIPTION LOT 103532 TI LOW PROFILE SCREW 6.5X25MM 170910, 103533 TI LOW PROFILE SCREW 6.5X30MM 182860, 13-104156 M/H 3HOLE RLC SHL NRS 56MM/L24 411970, EP-108524 E-POLY 40MM +3 HIWALL LNR SZ24 793640, 192409 ECHO POR FMRL RED NC 9X125MM 644330, S001140 SELEX/MAGNUM MOD HD 40MM STD 389200, 103532 TI LOW PROFILE SCREW 6.5X25MM 765860, 103533 TI LOW PROFILE SCREW 6.5X30MM 440310, 13-104156 M/H 3HOLE RLC SHL NRS 56MM/L24 450590, EP-108524 E-POLY 40MM +3 HIWALL LNR SZ24 344320, 192409 ECHO POR FMRL RED NC 9X125MM 730540, S331140 SELEX/MAGNUM MOD HD 40MM +3 499300. NO DEVICE WAS RETURNED FOR EVALUATION. EXAMINATION OF PROVIDED PATIENT RADIOGRAPHS CONFIRM THE REPORTED LINER FRACTURE IN-VIVO. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED STEEP POSITIONING OF THE ACETABULAR CUP WITH ACETABULAR INCLINATION ANGLE MEASURING APPROXIMATE 70°. THERE IS ASYMMETRIC POSITIONING OF THE FEMORAL HEAD WITHIN THE ACETABULAR CUP, CONSISTENT WITH POLYETHYLENE WEAR. HETEROTOPIC OSSIFICATION ALONG THE GREATER TROCHANTER. REVIEW OF DEVICE HISTORY RECORDS IDENTIFIED NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. 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 THE PATIENT WAS REVISED TO ADDRESS ACETABULAR LINER FRACTURE IN-VIVO. X-RAY REVIEW IDENTIFIED HETEROTOPIC OSSIFICATION AND MALPOSITIONING OF THE ACETABULAR CUP AS WELL ECCENTRIC LOADING OF THE FEMORAL HEAD INDICATIVE OF POLY WEAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399989 ECHO POR FMRL RED NC 9X125MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R ..