BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX40MM

    MDR report key: 6725790 · Received July 19, 2017

    Report

    Report Number
    1818910-2017-21340
    Event Type
    Injury
    Date Received
    July 19, 2017
    Date of Event
    June 20, 2017
    Report Date
    July 20, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295010395
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

      PRODUCT COMPLAINT # :(B)(4). INVESTIGATION SUMMARY:CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT STATES PATIENT WAS REVISED TO ADDRESS SEVERE HIP PAIN. UPON OPENING THE JOINT CAPSULE THERE WAS SEVERE METALLOSIS FROM A PREVIOUS SURGERY OCCURRING IN THE PAST 5 YEARS. SUMMIT STEM WAS LEFT IN SITU. SURGEON DECIDED TO REVISE ALL ACETABULAR COMPONENTS AND FULL SYNOVECTOMY. A REVIEW OF COMPLAINT DATABASES DID NOT IDENTIFY ANY ANOMALIES. A REVIEW OF MANUFACTURING RECORDS DID NOT IDENTIFY ANY ANOMALIES. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. POST MARKET SURVEILLANCE IS PER SEP 419. DEVICE HISTORY REVIEW :PRODUCT CODE (B)(4), WORK ORDER /LOT NO. (B)(4) WAS MANUFACTURED ON (B)(4)-2012 . 139 PCS PARTS WERE MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIALS MET SPECIFICATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS SEVERE HIP PAIN. UPON OPENING THE JOINT CAPSULE THERE WAS SEVERE METALLOSIS FROM A PREVIOUS SURGERY OCCURRING IN THE PAST 5 YEARS. SUMMIT STEM WAS LEFT IN SITU. SURGEON DECIDED TO REVISE ALL ACETABULAR COMPONENTS AND FULL SYNOVECTOMY. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. 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

    COMPLAINT DESCRIPTION: PATIENT WAS REVISED TO ADDRESS SEVERE HIP PAIN. UPON OPENING, THE JOINT CAPSULE THERE WAS SEVERE METALLOSIS FROM A PREVIOUS SURGERY OCCURRING IN THE PAST 5 YEARS. SUMMIT STEM WAS LEFT IN SITU. SURGEON DECIDED TO REVISE ALL ACETABULAR COMPONENTS AND FULL SYNOVECTOMY. DOI: (B)(6) 2013; DOR:(B)(6) 2017; UNKNOWN HIP.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS SEVERE HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506369 PINN CAN BONE SCREW 6.5MMX40MM HIP OTHER IMPLANT LPH DEPUY ORTHOPAEDICS INC US D12081354 10603295010395

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention