BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIM PRIMARY FEMORAL COMPONENT 75 MM LEFT / POROUS 75 LT

    MDR report key: 6986710 · Received October 30, 2017

    Report

    Report Number
    0001825034-2017-09715
    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
    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. THE FOLLOWING SECTIONS WERE UPDATED: MAXIM PRIMARY FEMORAL COMPONENT 75 MM LEFT / POROUS, 75 LT, PROCODE - JWH, MODEL #/LOT # - PN: 140074, LN: 622300, EXPIRATION DATE: DEC 31, 2010, IMPLANT DATE - (B)(6) 2001, CONCOMITANT MEDICAL PRODUCTS - (B)(6) 2017, DATE RECEIVED BY MFR - OCT 13, 2017, PMA# - K915132. IF FOLLOW-UP, WHAT TYPE? - ADDITIONAL INFORMATION, DEVICE MANUFACTURE DATE - DEC 8, 2000, CONCOMITANT MEDICAL PRODUCTS - BMET ARCOM AP PAT W/WIRE 37 MM CATALOG #: 11-150830 LOT #: 276460; MAX PRI DCM TIB BRNG12X71/75 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. CORRECTED -PRODUCT WAS NOT EXPLANTED. 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 AS NO WERE TRENDS IDENTIFIED. 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 PATELLAS CAT#: UNK, LOT# UNK. 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. PRODUCT HAS BEEN DISCARDED.

    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
    768742 MAXIM PRIMARY FEMORAL COMPONENT 75 MM LEFT / POROUS 75 LT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 622300

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R