BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD 12/14 TAPER

    MDR report key: 9844660 · Received March 17, 2020

    Report

    Report Number
    0002648920-2020-00166
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    October 18, 2017
    Report Date
    July 17, 2020
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VERSYS FIBER METAL TAPER FEMORAL STEM (00-7862-011-20, 60256034), VERSYS FEMORAL HEAD +0 (00-8018-036-02, 60806212), TM ACETABULAR SHELL (00-6202-056-22, 60924736), TRILOGY ACETABULAR LINER (00-6305-050-32, 60913479), TRILOGY ACETABULAR LINER (00-6305-050-36, 60691236), BONE SCREW (00-6250-065-30, 60903694). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE PRODUCT LOCATION IS UNKNOWN. 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 - 2016 - 02354 SHELL. 1822565 - 2016 - 00085 STEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP REPLACEMENT. PATIENT WAS REVISED NINE YEARS LATER DUE TO FEMORAL STEM LOOSENING, HETEROTOPIC OSSIFICATION, PAIN, SHELL LOOSENING, AND TISSUE DAMAGE. ACCORDING TO LEGAL DOCUMENT, STEM AND HEAD WERE EXPLANTED DURING REVISION. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305326 FEMORAL HEAD 12/14 TAPER PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 60806212

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10