BEUDAMED
    FDA Adverse Event Injury Summary report: N

    36MM I.D. SIZE F NEUTRAL LINER

    MDR report key: 14487885 · Received May 24, 2022

    Report

    Report Number
    0001822565-2022-01569
    Event Type
    Injury
    Date Received
    May 24, 2022
    Date of Event
    April 27, 2022
    Report Date
    May 24, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024518759
    PMA / PMN Number
    K190660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 010000664 ¿ G7 SHELL ¿ 7167132. 00625006525 ¿ BONE SCREW ¿ 63759079. 650-0662 ¿ DELTA HEAD ¿ 3090731. 192111 ¿ ECHO STEM - 501010. MEDICAL RECORDS WERE REVIEWED AND IDENTIFIED THAT THE PATIENT HAD BEEN BENDING AND TWISTING WHEN SUDDEN POP AND PAIN WAS FELT. THE NEXT DAY, ATTEMPTS WERE MADE TO DO A CLOSED REDUCTION BUT WERE UNSUCCESSFUL SO THE PATIENT UNDERWENT REDUCTION UNDER ANESTHESIA. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. IT WAS REPORTED THE PATIENT WAS BENDING AND TWISTING AND FELT A SUDDEN POP. HOWEVER, A ROOT CAUSE CANNOT BE IDENTIFIED. 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 THAT PATIENT WAS BENDING AND TWISTING WHEN THEY FELT A POP AND INCREASED PAIN IN LEFT HIP APPROXIMATELY 6 WEEKS POST HIP ARTHROPLASTY. THE PATIENT PRESENTED TO THE CLINIC AND WAS DIAGNOSED WITH DISLOCATION. THE PATIENT UNDERWENT A REDUCTION UNDER ANESTHESIA THE NEXT DAY. 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
    244919 36MM I.D. SIZE F NEUTRAL LINER PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 65255998 00889024518759

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H