BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PATELLA

    MDR report key: 8689850 · Received June 11, 2019

    Report

    Report Number
    0001822565-2019-02424
    Event Type
    Injury
    Date Received
    June 11, 2019
    Date of Event
    December 31, 2012
    Report Date
    June 13, 2019
    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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER: (B)(4).

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD CR ILOK FEM-RT 70, ITEM# 183012, LOT# 325910. BMET REGENX PRI TIB TRAY 75MM, ITEM# 141274, LOT# 278890. BIOMET FINNED PRI STEM 40MM, ITEM# 141314, LOT# 896740. VNGD CR TIB BRG 10X71/75, ITEM# 183440, LOT# 560800. COBALT G-HV BONE CEMENT 40G, ITEM# 402283, LOT# 768500. 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 PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY ONE MONTH POST IMPLANTATION DUE TO PAIN AND INSTABILITY. A SURGICAL REVISION AND PATELLECTOMY WAS PERFORMED. THE PATELLA BONE WAS REPLACED BY A FULLY PROSTHETIC IMPLANT. THERE IS NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480921 UNKNOWN PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R