BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ARCOM ALL POLY PAT. BUTTON W/X-RAY WIRE/37 MM (LARGE)

    MDR report key: 6986715 · Received October 30, 2017

    Report

    Report Number
    0001825034-2017-09714
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    October 2, 2017
    Report Date
    February 26, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    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

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY A ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CONCOMITANT MEDICAL PRODUCTS - MAXIM POR ANA PRI FML, 75 LT CATALOG #: 140074 LOT #: 622300; MAX PRI DCM TIB, BRNG12 X 71/75 MM CATALOG #: 11-146152 LOT #: 158660, AND BIOMET CC CRUCIATE TRAY 75 MM CATALOG #: 141234 LOT #: 229370. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED 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

    (B)(4) MEDICAL PRODUCT: UNKNOWN VANGUARD TIBIAL BEARING CAT#: UNK, LOT# UNK. UNKNOWN KNEE FEMORAL CAT#: UNK, LOT# UNK. CABLE CERCLAGE CABLE WITH CRIMP CAT#: 00223200418, LOT# 63578894. CABLE CERCLAGE CABLE WITH CRIMP CAT#: 00223200418, LOT# 63769049. BIOMET TIBIAL LOCKING BAR CAT#: 141205, LOT# 341080. VANGUARD AS TIBIAL BEARING CAT#: EP-189062, LOT# 465120. SERIES PATELLA STANDARD CAT#: 184768, LOT# 083680. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. 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 - 09713, 0001825034 - 2017 - 09714, 0001825034 - 2017 - 09715.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL 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 A PATIENT UNDERWENT REVISION AFTER APPROXIMATELY TWENTY YEARS AFTER INITIAL KNEE PROCEDURE DUE TO FEMUR FRACTURE. SURGEON TREATED FEMUR FRACTURE, EXCHANGED WORN ARTICULAR SURFACE, AND REVISED PATELLA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION AFTER APPROXIMATELY TWENTY YEARS AFTER INITIAL KNEE PROCEDURE DUE TO FEMUR FRACTURE. SURGEON TREATED FEMUR FRACTURE, EXCHANGED WORN ARTICULAR SURFACE FOR BETTER STABILITY AND EXCHANGED THE WORN PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766483 BIOMET ARCOM ALL POLY PAT. BUTTON W/X-RAY WIRE/37 MM (LARGE) PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 276460

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R SEE H10