BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM FIBER METAL MIDCOAT COLLARED 12/14 NECK TAPER

    MDR report key: 9687554 · Received February 10, 2020

    Report

    Report Number
    0001822565-2020-00533
    Event Type
    Injury
    Date Received
    February 10, 2020
    Date of Event
    January 17, 2019
    Report Date
    May 12, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: G4; H2; H3; H6 REPORTED EVENT WAS CONFIRMED VIA MEDICAL RECORDS. THE PATIENT WAS FOUND TO HAVE ELEVATED METAL ION LEVELS BASED ON THE LABS. METAL DEBRIS AND CORROSION WERE NOTED AT THE TRUNNION AND WAS REMOVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED D11: 00875201336-LINER ELEVATED RIM 36 MM-64030504; 62926540- BIOLOX® OPTION- 2952035; 00875705801- SHELL WITH CLUSTER HOLES- 62375661; 00625006525- BONE SCR 6.5X25 SELF-TAP- 62935925; 00625006525- BONE SCR 6.5X25 SELF-TAP-62913697. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 00777. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT UNDERWENT AN INITIAL RIGHT THA. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO ELEVATED METAL IONS, CORROSION AND PAIN. DURING THE PROCEDURE THE HEAD AND LINER WERE REVISED. METAL DEBRIS, CORROSION AT THE TRUNNION WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN-UNKNOWN VERSYS HEAD-UNKNOWN. UNKNOWN-UNKNOWN CUP -UNKNOWN. UNKNOWN-UNKNOWN LINER-UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 00534. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT LOCATION UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151618 FEMORAL STEM FIBER METAL MIDCOAT COLLARED 12/14 NECK TAPER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62926540

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R