BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOD ARTHRO NL 1CM ELIP CNCTR

    MDR report key: 9192220 · Received October 15, 2019

    Report

    Report Number
    0001825034-2019-04114
    Event Type
    Injury
    Date Received
    October 15, 2019
    Date of Event
    January 7, 2019
    Report Date
    October 15, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    PMA / PMN Number
    K042409
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. UDI # (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM # 150375 LOT # 607180, ITEM # CP260601 LOT # 392490, ITEM # 150386 LOT # 685510, ITEM # CP60607 LOT # 297740. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS PROVIDED. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. THE MEDICAL RECORDS STATE THAT PATIENT UNDERWENT REVISION SURGERY DUE TO ONGOING INFECTION AFTER 1 YEAR, 5 MONTHS AFTER OSS IMPLANTATION. OFFICE NOTES STATE THAT SMALL AMOUNT OF DRAINAGE NOTED AT SURGICAL SITE. INTRAOP CULTURES REVEALED E. COLI, P MIRABILIS, GBS. STAGE II REVISION PLANNED WHEN CLEARED BY INFECTIOUS DISEASE. OFFICE NOTES STATE THAT PATIENT NOTICED SWELLING IN THE MEDIAL ASPECT OF HIS KNEE AND ALSO ANTERIORLY. THERE IS PURULENCE AS WELL AND THIS HAS DRAMATICALLY WORSENED OVER THE LAST FEW DAYS. X-RAY REVIEW BY THIRD PARTY HCP STATED THAT THERE IS A FRACTURE NOTED IN THE DISTAL FEMORAL COMPONENT AT THE JUNCTION OF THE DIAPHYSEAL SEGMENT AND SEGMENTAL DISTAL FEMORAL COMPONENT. METALLIC SMALL DISPLACED FRACTURE COMPONENT SEEN IN THE POPLITEAL REGION. ADDITIONALLY NOTED PERIPROSTHETIC LUCENCY SURROUNDING THE CEMENTED COMPONENTS OF THE DISTAL FEMUR AND CEMENT COMPONENT OF THE PROXIMAL TIBIA. THE REPORTED KNEE SYSTEM WAS PLACED INTO AN ALREADY INFECTED JOINT SPACE WITH SEVERE BONE LOSS, THEREFORE THE ROOT CAUSE OF THE INFECTION CAN BE ATTRIBUTED TO A PATIENT CONDITION AND CAN BE CONFIRMED BASED ON REVIEW OF THE MEDICAL RECORDS. HOWEVER, THE ROOT CAUSE OF THE REVISION CAN NOT BE DETERMINED AND AS THE SALES REP WAS UNABLE TO CONFIRM THE IMPLANT FAILURE WAS FRACTURE OF THE DIAPHYSEAL CONNECTOR, THE REASON FOR REVISION CANNOT BE CONFIRMED. 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 UNDERWENT A TOTAL KNEE ARTHROPLASTY AND SUBSEQUENTLY HAD TO HAVE A REVISION DUE TO A FRACTURE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988516 MOD ARTHRO NL 1CM ELIP CNCTR PROSTHESIS, KNEE HSB ZIMMER BIOMET, INC. N/A 257270

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention