BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BMT SMOOTH KNEE STEM 14X80

    MDR report key: 9729351 · Received February 19, 2020

    Report

    Report Number
    0001825034-2020-00778
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    December 20, 2019
    Report Date
    April 22, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICES OR PHOTOS WERE RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENTS IS UNKNOWN. SURGICAL NOTES WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. 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 THAT A PATIENT WAS REVISED APPROXIMATELY SIX YEARS AND FIVE MONTHS POST IMPLANTATION DUE TO IMPLANT FRACTURE, PAIN, AND LOOSENING OF THE FEMORAL COMPONENT. WITH REGARDS TO THE RETAINED FOREIGN BODY THE BROKEN OFF SCREW HAD MIGRATED TO SOFT TISSUE IN THE POPLITEAL FOSSA AND THE SURGEON DEEMED THAT IT WOULD BE UNNECESSARILY COMPLICATED AND HIGH RISK TO REMOVE THAT ITEM FROM THAT AREA AND IT WOULDN¿T CAUSE ANY FURTHER ISSUES. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2019-05075-1. CONCOMITANT MEDICAL PRODUCTS: RHK RIGHT STD RESURF FEMUR ITEM# 154976 LOT# 2696535, RHK STD FEMORAL AUGMENT 10RM ITEM# 159463 LOT# 1332752, RHK SHORT HINGE ASSEMBLY ITEM# 161583 LOT# 3050854. REPORT SOURCE: (B)(6). 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 A PATIENT WAS REVISED DUE TO PAIN, FEMORAL LOOSENING, AND IMPLANT FRACTURE. THERE IS A FRACTURE AT THE TAPPER JUNCTION ON THE FEMORAL SIDE OF A BIOMET RHK (ROTATING HINGED KNEE) REVISION KNEE. A LOSE FEMORAL STEM SCREW IS ALSO SEEN ON THE LATERAL X-RAY. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189591 BMT SMOOTH KNEE STEM 14X80 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 513760

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R