BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC I-BEAM TRAY 63MM

    MDR report key: 7282963 · Received February 20, 2018

    Report

    Report Number
    0001825034-2018-01166
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    August 4, 2016
    Report Date
    February 4, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE COULD NOT 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    CLINICAL STUDY 501 - IT WAS REPORTED AS PART OF A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE ON (B)(6) 2016. SUBSEQUENTLY, AT THE SIX MONTH FOLLOW-UP APPOINTMENT, THE PATIENT HAD SWELLING, WHICH WAS TREATED WITH AN ASPIRATION AND INJECTION. ALSO DURING THE 6 MONTH AND 1 YEAR FOLLOW UP APPOINTMENT, THE PATIENT REPORTED EXPERIENCING EXTREME/SEVERE CONTINUAL PAIN WHICH HAS GREATLY INTERFERED WITH USUAL WORK; OFTEN FELT KNEE WOULD GIVE WAY. ALSO PROBLEMS WALKING ABOUT AND DOWN STAIRS, PERFORMING USUAL ACTIVITIES LIKE SHOPPING, TROUBLE GETTING IN OR OUT OF CAR, LIMPING MOST OF TIME, AND EXTREMELY DIFFICULT TO KNEEL DOWN. REPORTED USING A CANE.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-01165, 0001825034-2018-01167. CONCOMITANT MEDICAL PRODUCTS: CAT 195907 ¿ LOT 994180 - VGXP INTLK FEMORAL RT, CAT 183520 ¿ LOT 900810 ¿ VNGD CR LIP TIB BRG. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORDS FOR ALL THE REPORTED DEVICES WERE IDENTIFIED WITH NO DEVIATIONS OR ANOMALIES. THE REPORTED DEVICES ARE USED FOR TREATMENT. THE REPORTED COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED: PN/LN: 195907/994180, 141221/J3333583, 183520/900810. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. REVIEW OF THE MEDICAL RECORDS INDICATES THAT THE SURGEON NOTED NO COMPLICATIONS DURING SURGERY. SURGICAL NOTES WERE NOT PROVIDED IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION.

    Description of Event or Problem · 1

    CLINICAL STUDY 501 - IT WAS REPORTED AS PART OF A CLINICAL STUDY THAT A PATIENT UNDERWENT AN INITIAL RIGHT KNEE PROCEDURE ON (B)(6) 2016. DURING A 6 MONTH AND 1 YEAR FOLLOW UP APPOINTMENT, THE PATIENT REPORTED EXPERIENCING EXTREME/SEVERE CONTINUAL PAIN WHICH HAS GREATLY INTERFERED WITH USUAL WORK; OFTEN FELT KNEE WOULD GIVE WAY. ALSO PROBLEMS WALKING ABOUT AND DOWN STAIRS, PERFORMING USUAL ACTIVITIES LIKE SHOPPING, TROUBLE GETTING IN OR OUT OF CAR, LIMPING MOST OF TIME, AND EXTREMELY DIFFICULT TO KNEEL DOWN. REPORTED USING A CANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127650 BIOMET CC I-BEAM TRAY 63MM PROSTHESIS - KNEE JWH ZIMMER BIOMET, INC. N/A J3333583

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other