BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPICCI TIBIAL 37X6.5MM

    MDR report key: 4707510 · Received April 20, 2015

    Report

    Report Number
    0001825034-2015-01580
    Event Type
    Injury
    Date Received
    April 20, 2015
    Date of Event
    March 20, 2015
    Report Date
    March 23, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HRY
    PMA / PMN Number
    PK980665
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO CORRECT INFORMATION. PART/LOT INFORMATION COULD BE: LOT NUMBER - 050090, EXPIRATION DATE - APR 30, 2009, MANUFACTURE DATE ¿ APR 15, 2004. OR THE PART/LOT INFORMATION COULD BE: LOT NUMBER - 568870, EXPIRATION DATE - JAN 31, 2009, MANUFACTURE DATE ¿ JAN 14, 2004.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO DEVICES WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENTS IS UNKNOWN. REVIEW OF THE DEVICE HISTORY RECORDS FOR 102150 LOT 050090 AND 102150 LOT 568870 IDENTIFIED NO DEVIATIONS OR ANOMALIES. THE FOLLOWING COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED: 102150 AND RD102130. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE PROVIDED PART AND LOT COMBINATIONS. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT BILATERAL PARTIAL KNEE ARTHROPLASTY ON (B)(6) 2004. SUBSEQUENTLY, PATIENT WAS REVISED (B)(6) 2015 DUE TO SUBSIDENCE AND LOOSENING. THE TIBIAL COMPONENT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259516 REPICCI TIBIAL 37X6.5MM PROSTHESIS, KNEE HRY BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R