BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER STANDARD 32 MM

    MDR report key: 12589498 · Received October 7, 2021

    Report

    Report Number
    0001822565-2021-02708
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    December 19, 2016
    Report Date
    October 21, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K990135
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE LINER WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, THE LINER WAS DETERMINED TO BE NOT REPORTABLE. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M/L TAPER FEMORAL STEM (00-7711-009-10, 61389207); VERSYS FEMORAL HEAD +0 (00-8018-032-02, 61452283); TRILOGY ACETABULAR SHELL (00-6200-052-22, 61417334); BONE SCREW (00-6250-065-25, 61436562). CUSTOMER HAS 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: 0001822565-2017-00010, 0001822565-2018-01457.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO PAIN. ALVAL/CORROSION/METALOSIS LIKE SYMPTOMS WERE ALSO RECORDED. POLY COMPONENT WAS NOTED TO BE YELLOWED AND SCRATCHED. THERE WERE NO COMPLICATIONS OR DELAYS REPORTED. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488385 LINER STANDARD 32 MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 61342619

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE.