BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM SCREW LOW PROF 5X40MM

    MDR report key: 3107453 · Received May 10, 2013

    Report

    Report Number
    0001825034-2013-01414
    Event Type
    Injury
    Date Received
    May 10, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HSD
    PMA / PMN Number
    PK991807
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR. UNDER POSSIBLE ADVERSE EFFECTS, NUMBER 2, "EARLY OR LATE POSTOPERATIVE, INFECTION, AND ALLERGIC REACTION." REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THIS REPORT IS NUMBER 1 OF 7 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2013-01408 / 01414).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. ADDITIONAL INFORMATION INDICATES THE LEFT HIP WAS IRRIGATED AND DEBRIDED; HOWEVER, NO COMPONENTS WERE REMOVED AND REPLACED. THIS REPORT IS NUMBER 7 OF 7 MDRS FILED FOR THE SAME PERSON (REFERENCE 1825034-2013-01408-1 / 01414-1).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY (B)(6) 2002. PATIENT WAS RETURNED TO OPERATING ROOM (B)(6) 2002 TO REPOSITION CUP AND IMPLANT SCREW. A SUBSEQUENT IRRIGATION AND DEBRIDEMENT WAS PERFORMED (B)(6) 2002 WITH A REVISION OF ALL IMPLANTS ON (B)(6) 2013 DUE TO UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE PROCEDURE TO REPOSITION THE CUP AND IMPLANT THE SCREW ON (B)(6) 2002 WAS PERFORMED ON THE LEFT HIP. SUBSEQUENTLY, MEDICAL RECORDS INDICATE THE IRRIGATION AND DEBRIDEMENT OF A HEMATOMA ON THE LEFT HIP OCCURRED ON (B)(6) 2002. MEDICAL RECORDS INDICATED THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2013 ON THE RIGHT HIP WAS DUE TO AN ADVERSE REACTION TO METAL DEBRIS. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP AND MODULAR HEAD WERE REMOVED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT ENROLLED IN CLINICAL STUDY, UNDERWENT BILATERAL TOTAL HIP ARTHROPLASTY ON (B)(6) 2002. PATIENT WAS RETURNED TO OPERATING ROOM ON (B)(6) 2002 TO REPOSITION CUP AND IMPLANT SCREW. A SUBSEQUENT IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON (B)(6) 2002 WITH A REVISION OF ALL IMPLANTS ON (B)(6) 2013 DUE TO UNKNOWN REASON. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208510 TITANIUM SCREW LOW PROF 5X40MM PROSTHESIS, HIP HSD BIOMET ORTHOPEDICS N/A 380690

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R