BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HXPE LINER NEUT 48 GG X 28

    MDR report key: 8000576 · Received October 24, 2018

    Report

    Report Number
    0001822565-2018-05832
    Event Type
    Injury
    Date Received
    October 24, 2018
    Date of Event
    June 14, 2012
    Report Date
    February 11, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K151448
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF SURGICAL NOTES. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: LINER NEUTRAL 28 MM I.D. SIZE GG FOR USE WITH 48 MM O.D. SIZE GG SHELL, PN 00875100828, LN 61658577. (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 28/-3.5, TAPER 12/14, PN 00877502801, LN 2633555. (B)(4). CONCOMITANT MEDICAL PRODUCTS: LINER NEUTRAL 28 MM I.D. SIZE GG FOR USE WITH 48 MM O.D. SIZE GG SHELL, PN 00875100828, LN 61658577. (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, ø 28/-3.5, TAPER 12/14, PN 00877502801, LN 2633555. REPORTING SOURCE: (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT. PLEASE SEE REPORTS: 0001822565-2018-05684, 0009613350-2018-01082, 0001822565-2018-05833, 0009613356-2018-01087. 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 PATIENT HAD A LUXATION OF THE PROSTHESIS EIGHT DAYS POST-IMPLANTATION, PROBABLY DUE TO A FALSE MOVEMENT. IT WAS SOLVED ON THE SAME DAY WITH AN EXTERNAL REDUCTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840493 HXPE LINER NEUT 48 GG X 28 PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 61658577

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R