BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MLRY-HD POR FMRL 11X160MM

    MDR report key: 8063983 · Received November 13, 2018

    Report

    Report Number
    0001825034-2018-10510
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    February 2, 2017
    Report Date
    May 4, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K030055
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: D10: CAT# 157442 LOT# 831010 M2A-MAGNUM MOD HD, CAT# 139254 LOT# 000880 M2A-MAGNUM 42-50MM, CAT# US157848 LOT# 724930 M2A-MAGNUM PF CUP. H6: COMPONENT CODE: MECHANICAL (G04) - STEM. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED THE DEVICES REMAIN ASSEMBLED UPON RECEIPT. VISUAL INSPECTION FOUND SCRATCHING ON THE EXPOSED SURFACE OF THE INSERT. THE TAPER IS ETCHED -3. DARK DEBRIS AND SCUFFING ARE PRESENT INSIDE THE TAPER OF THE INSERT. SCRATCHING WAS OBSERVED ON THE OUTSIDE OF THE HEAD IN MULTIPLE LOCATIONS. THE HEAD IS ETCHED 42. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES 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.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON INVESTIGATION RESULTS OF THE RETURNED FEMORAL HEAD, THE DEVICE SHOWS WEAR ON BOTH THE ARTICULATING SURFACE AND DISCOLORATION ON THE TAPER. BASED ON THIS THE FEMORAL STEM HAS BEEN REVERTED TO REPORTABLE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR'S WERE FILED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORT(S): 0001825034-2018-10508, 0001825034-2018-10509. REPORTED EVENT WAS UNABLE TO BE CONFIRMED AS PART NUMBER / LOT NUMBER OF DEVICE INVOLVED IN THE INCIDENT IS UNKNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906228 MLRY-HD POR FMRL 11X160MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 814590
    906229 MLRY-HD POR FMRL 11X160MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 814590

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Hospitalization| R SEE H10 NARRATIVE| UNK PART LOT, CUP, HEAD| UNK PART LOT, CUP, HEAD