BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG FEM ADAP +2/-2 OFFSET BOLT

    MDR report key: 4221182 · Received November 3, 2014

    Report

    Report Number
    1818910-2014-31013
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 13, 2014
    Report Date
    March 20, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK060515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION, HOWEVER A DHR WAS CONDUCTED WITH NO ANOMALIES OR NONCONFORMACES FOUND. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4). UPDATE 6/4/15 & 6/8/15 MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS RECEIVED, THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE RECEIVED X-RAYS WERE REVIEWED. IMAGES SHOW THE HEAD OF THE BOLT "FLOATING" IN THE JOINT SPACE. THIS IS CONSISTENT WITH THE REPORTED BOLT FRACTURE. NO EVIDENCE OF FRACTURE OF ANY OTHER DEVICE, DISASSOCIATION, OR ANYTHING INDICATIVE OF A DEVICE NONCONFORMANCE WAS FOUND. THE RECEIVED MEDICAL RECORDS WERE REVIEWED BY A DEPUY MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4).THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN, CLICKING AND A BROKEN BOLT.

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED. A CORRECT DOI WAS PROVIDED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN CLICKING, AND FRACTURED LOCKING SCREW FROM THE FEMORAL COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702533 SIG FEM ADAP +2/-2 OFFSET BOLT KNEE OTHER IMPLANT JWH DEPUY ORTHOPAEDICS, INC. EK3MA1

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention