BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHK RIGHT STD RESURF FEMUR

    MDR report key: 9304497 · Received November 11, 2019

    Report

    Report Number
    0001825034-2019-05075
    Event Type
    Injury
    Date Received
    November 11, 2019
    Date of Event
    December 20, 2019
    Report Date
    April 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS REPORTED IN ERROR. THE PREVIOUS REPORTS WERE SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO UPDATE COMPLAINT DESCRIPTION, PRODUCT ID, AND ASSOCIATED INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001825034-2020-00778. D11- MEDICAL PRODUCT BMT SMOOTH KNEE STEM 14X80 ITEM# 145024 LOT# 513760 RHK STD FEMORAL AUGMENT 10RM ITEM# 159463 LOT# 1332752 RHK SHORT HINGE ASSEMBLY ITEM# 161583 LOT# 3050854 UPDATED: B2, B3, B4, B5, D1, D4, D7, D11, G4, G7, H1, H2, AND H10.

    Description of Event or Problem · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS REPORTED IN ERROR. THE PREVIOUS REPORTS WERE SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 0

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AT THIS TIME AS IT REMAINS IMPLANTED. 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 IS BEING CONSIDERED FOR A REVISION DUE TO PAIN, FEMORAL LOOSENING, AND IMPLANT FRACTURE. THE SURGEON SUSPECTS 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
    1097704 RHK RIGHT STD RESURF FEMUR PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 2696535

    Patients

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