BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPS FLEX FEMORAL COMPONENT

    MDR report key: 7784685 · Received August 15, 2018

    Report

    Report Number
    0001822565-2018-04303
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    July 12, 2018
    Report Date
    October 10, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK062768
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DHR WAS REVIEWED FOR DEVIATIONS AND / OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED A DEFINITIVE ROOT CAUSE CANNOT 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). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 0001822565-2018-04305, 0001822565-2018-04306. (B)(4). CONCOMITANT MEDICAL PRODUCTS. ARTICULAR SURFACE USE WITH LPS/LPS-FLEX 51 OR 52 SUFFIX FEMORALS SIZE EF 10 MM HEIGHT. ITEM# 00596204010 LOT# 63615052. TIBIAL COMPONENT STEMMED PRECOAT USE OF THIS TIBIAL COMPONENT WITH LEGACY KNEE - CONSTRAINED CONDYLAR KNEE (LCCK) ARTICULATING SURFACES REQUIRES USING ITEM# 00-5980-047-01 LOT# 63392593. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AND INITIAL ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627938 LPS FLEX FEMORAL COMPONENT PROSTHESIS- KNEE JWH ZIMMER BIOMET, INC. N/A 63597351

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R