BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER FEM HD 28/0MM T1 M T1

    MDR report key: 8559773 · Received April 29, 2019

    Report

    Report Number
    3002806535-2019-00410
    Event Type
    Injury
    Date Received
    April 29, 2019
    Report Date
    August 19, 2019
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K141653
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4, G4, G7, H1, H2, H4, H6, H10. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT PROCEDURE. SUBSEQUENTLY, AFTER A ROUTINE X RAY A DISLOCATION OF THE E1 ACTIVE LINER FROM THE 28MM CERAMIC HEAD DUE TO AN UNKNOWN REASON. IT IS STILL FUNCTIONING INDEPENDENTLY WITH CERAMIC ON METAL BEARING.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT:G7 DUAL MOBILITY LINER 44MM F, CATALOG #:110024464, LOT #: 231540, MEDICAL PRODUCT: TPRLC XR MP FP T1 PPS 6X97.5MM, CATALOG #: 51-149060, LOT #: 3822018, MEDICAL PRODUCT:G7 PPS LTD ACET SHELL 54F, CATALOG #: 010000664, LOT #: 6047001. REPORT SOURCE: (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP REPLACEMENT PROCEDURE. SUBSEQUENTLY, THE PATIENT EXPERIENCED DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354687 DELTA CER FEM HD 28/0MM T1 M T1 HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2016061373

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10.