BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET REGENEREX PRIMARY TIBIAL TRAY

    MDR report key: 7262189 · Received February 9, 2018

    Report

    Report Number
    0001825034-2018-00419
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    December 7, 2017
    Report Date
    April 27, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MMI REPORT AND X-RAYS PROVIDED. THREE MONTHS POST-OP PERIPROSTHETIC LUCENT ZONE SURROUNDING THE MEDIAL MOST SCREW ASSOCIATED WITH THE TIBIAL PLATE WAS FOUND. A THIN SPACE IS ALSO PRESENT BETWEEN THE LATERAL ASPECT OF THE TIBIAL PLATE AND THE TIBIAL PLATEAU (BONE INTERFACE). ON THE LATERAL VIEW, SEEN FOR THE FIRST TIME IS A TEARDROP SHAPED FRACTURE FRAGMENT ALONG THE ANTERIOR ASPECT OF THE TIBIAL PLATE. 12 MONTHS POSTOP MILD DEPRESSION OF THE MEDIAL PLATE WAS FOUND. THERE IS INCREASED SCLEROSIS INFERIOR TO THE MEDIAL MOST SCREW WHICH SUGGESTS COMPACTION OF TRABECULA (NONDISPLACED COMPRESSION) RELATED TO THE DEPRESSED PLATE. LUCENCY SURROUNDING THE MEDIAL SCREW REMAINS. REMAINDER OF HARDWARE APPEARS INTACT AND NORMAL. X-RAY REVIEW INDICATED TIBIAL COMPONENT FRACTURE CONFIRMED. IN ADDITION, TIBIAL COMPONENT LOOSENING AND TRABECULAR COMPRESSION FRACTURE NOTED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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). REPORT SOURCE: (B)(6). 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: VANGUARD ILOK FEMORAL COMPONENT, CATALOG #: 183014, LOT #: 492780, BIOMET FINNED STEM, CATALOG #: 141314, LOT #: 971840, VANGUARD TIBIAL BEARING, CATALOG #: 183460, LOT #: 009910, BIOMET ARCOM PATELLA, CATALOG #: 11-150822, LOT #: 754320. 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 DUE TO A BROKEN TIBIAL COMPONENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103106 BIOMET REGENEREX PRIMARY TIBIAL TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 981810

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R