BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHO B-MTRC MP FP HO 9

    MDR report key: 14015318 · Received April 5, 2022

    Report

    Report Number
    0001825034-2022-00798
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    March 4, 2022
    Report Date
    April 8, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304697911
    PMA / PMN Number
    K143009
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 010000663- G7 PPS LTD ACET SHELL 52E- 7123845, 20103605- G7 LONGEVITY NEUTRAL 36MM E- 65255946, 650-0661- DELTA CERAMIC FEM HD 36/0MM- 3090519, 00625006530- BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH- J7146594, 00625006520- BONE SCREW SELF-TAPPING 6.5 MM DIA. 20 MM LENGTH- 65044174. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED VIA MEDICAL RECORDS REVIEWED BY A HEALTH CARE PROFESSIONAL. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING AN INITIAL PROCEDURE THAT A GREATER TROCHANTERIC FRACTURE NONDISPLACED NOTED AT TIME OF SURGERY AND ON POSTOPERATIVE X-RAY. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2341628 ECHO B-MTRC MP FP HO 9 PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 147800 00880304697911

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SEE H10.