BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ACROM PATELLA

    MDR report key: 6861990 · Received September 13, 2017

    Report

    Report Number
    0001825034-2017-07029
    Event Type
    Injury
    Date Received
    September 13, 2017
    Date of Event
    August 15, 2017
    Report Date
    June 1, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK921182
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN MAXIM BEARING, CAT#: UNKNOWN, LOT#: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT HAS BEEN DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-07028. PRODUCT WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW AND THE PATIENT¿S TIBIAL DISLOCATION WAS CONFIRMED THROUGH RADIOGRAPHIC REVIEW. HOWEVER, THE INSTABILITY AND PATELLAR WEAR WERE UNABLE TO BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A RADIOGRAPHIC REVIEW INDICATED THAT THE RIGHT KNEE HAD EVIDENCE OF ANTERIOR DISLOCATION OF THE TIBIA, BUT NO RADIOLUCENCY OR ACUTE FRACTURE. A 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.

    Additional Manufacturer Narrative · 1

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTION AND ADDITIONAL INFORMATION. MEDICAL PRODUCT - MAXIM POR ANA PRI CAT#: 140051, LOT#: 583780; BIOMET ILOK PRI TI CAT#: 141212, LOT#: 180990 ; BIOMET FINNED PRI CAT#: 141314, LOT#: 290950 ; MAX PRI-LIP TIB BR CAT#: 146336, LOT#: 735410. PRODUCT ID INITIALLY REPORTED WAS FOR THE CONTRALATERAL SIDE AND NOW UPDATED TO CURRENT PRODUCT INFORMATION. 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND POLYETHYLENE WEAR. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND PATELLA WEAR. THE X-RAY REVIEW CONFIRMED AN ANTERIOR DISLOCATION OF THE TIBIA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643014 BIOMET ACROM PATELLA PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 453730

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R