BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCM MAXIM PRIMARY TIBIAL BEARING 12 MM THICK X 71/75 WIDE ARCOM UHMWPE

    MDR report key: 6986713 · Received October 30, 2017

    Report

    Report Number
    0001825034-2017-09713
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    October 2, 2017
    Report Date
    February 23, 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: BRAND NAME - DCM MAXIM PRIMARY TIBIAL BEARING 12 MM THICK X 71/75 WIDE ARCOM UHMWPE. PROCODE - JWH. MODEL #/LOT # - PN: 11-146152. LN: 158660. EXPIRATION DATE: AUG 30, 2005. IMPLANT DATE - (B)(6) 2001. CONCOMITANT MEDICAL PRODUCTS - (B)(6) 2017. DEVICE RECEIVED BY MFR DATE - OCT 13, 2017. PMA # - K915132. IF FOLLOW-UP, WHAT TYPE? - ADDITIONAL INFORMATION. DEVICE MFR DATE - AUG 16, 2000 CONCOMITANT MEDICAL PRODUCTS - BMET ARCOM AP PAT W/WIRE 37 MM CATALOG #: 11-150830 LOT #: 276460; MAXIM POR ANA PRI FML 75 LT CATALOG #: 140074 LOT #: 622300, 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

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: UNKNOWN KNEE PATELLAS CAT#: UNK, LOT# UNK. UNKNOWN KNEE FEMORAL 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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768744 DCM MAXIM PRIMARY TIBIAL BEARING 12 MM THICK X 71/75 WIDE ARCOM UHMWPE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 158660

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R