BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER STANDARD 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS

    MDR report key: 8750554 · Received July 1, 2019

    Report

    Report Number
    0001822565-2019-02778
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    September 26, 2016
    Report Date
    July 29, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K990135
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE DEVICE WAS REPORTED UNDER WRONG MANUFACTURING SITE. EVENT WILL BE REPORTED UNDER MFR 0002648920-2019-00559.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE DEVICE WAS REPORTED UNDER WRONG MANUFACTURING SITE. EVENT WILL BE REPORTED UNDER MFR 0002648920-2019-00559.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: M/L TAPER FEMORAL STEM, PRESS-FIT, PLASMA SPRAYED, REDUCED NECK LENGTH, SIZE 7.5 (00-7711-007-10, 61418549). VERSYS FEMORAL HEAD, 32 MM, +0 MM NECK (00-8018-032-02, 61484662). TRILOGY ACETABULAR SHELL, 52 MM (00-6200-052-22, 61429549). BONE SCREW (00-6250-065-25, 61432048). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2016-03229 AND 0001822565-2016-03862. 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 WAS REVISED APPROXIMATELY 6 YEARS POST INITIAL SURGERY DUE TO DISLOCATION. PATIENT EXPERIENCE A DISLOCATION APPROXIMATELY 6 MONTHS PRIOR TO REVISION. PRE-SURGICAL WORKUP INDICATED ELEVATED METAL IONS. DURING THE REVISION, SURGEON REPORTED THE FOLLOWING: TISSUE DAMAGE, DEBRIS, PLASTIC FRAGMENTS IN THE CAPSULE, LINER HAD FRAGMENTED, AND STATED LOCKING RING WAS LOCKED AND NOT MOBILE, CORROSION TO NECK & HEAD, THEREFORE HEAD AND LINER WERE EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543063 LINER STANDARD 32 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 61412972

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R