BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHELL WITH CLUSTER HOLES POROUS 52 MM O.D. SIZE II FOR USE WITH II LINERS

    MDR report key: 7951661 · Received October 10, 2018

    Report

    Report Number
    0001822565-2018-05630
    Event Type
    Injury
    Date Received
    October 10, 2018
    Date of Event
    September 5, 2018
    Report Date
    March 14, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK091508
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED A ZIMMER BIOMET 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 A ZIMMER BIOMET 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). PATIENT YEAR OF BIRTH (B)(6). CONCOMITANT MEDICAL PRODUCTS: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 7.5 STANDARD OFFSET, PN 00771100700, LN 61694547. METASUL HEAD 36 12/14 SZM/0 /0, PN 00877003602, LN 2564470. METASUL TAPER LINER II/36, PN 00877001036, LN 2555965. REPORTING SOURCE (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001822565-2018-05629. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED FASCIA LATAE RUPTURE ON THE LEFT HIP. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791994 SHELL WITH CLUSTER HOLES POROUS 52 MM O.D. SIZE II FOR USE WITH II LINERS PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 61726734

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other