BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX25MM

    MDR report key: 4142155 · Received October 4, 2014

    Report

    Report Number
    1818910-2014-29420
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    January 18, 2012
    Report Date
    October 20, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    NDJ
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FOUND ONE OTHER REPORT AGAINST THE D00450557 BONE SCREW. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATIONS. MEDICAL RECORDS WERE REVIEWED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION MADE AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. MONITOR VIA SEP-419. 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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. UDI: (B)(4).

    Description of Event or Problem · 1

    UPDATE REC'D 1/25/2016: LITIGATION PAPERS. IN ADDITION TO WHAT HAS ALREADY BEEN ALLEGED, THE LITIGATION ALSO ALLEGES DISCOMFORT AND CORROSION/FRICTION CAUSING INCREASED METAL IONS AND METAL DEBRIS. THE PREVIOUS REVIEW OF THE MEDICAL RECORDS INDICATED THE REVISION OPERATIVE NOTE DIDN'T INDICATE ANY CORROSION OR METAL DEBRIS. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. IT SHOULD BE NOTED THAT THE PATIENT HAD A POLY ON CERAMIC CONSTRUCT. THIS COMPLAINT WAS UPDATED ON: 1/28/2016.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT.- LITIGATION ALLEGES THAT PATIENT WAS REVISED DUE TO PAIN WITH LOOSENING AND FEMORAL COMPONENT SUBSIDENCE. UPDATE: (B)(6) 2012 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. PATIENT DEMOGRAPHICS ADDED. UPDATE REC'D (B)(6) 2014 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE REVISION OPERATIVE NOTE INDICATED PAIN, STEM LOOSENING, AND SUBSIDENCE OF THE STEM. THE CUP, LINER, FEMORAL HEAD, AND SCREW ARE BEING REPORTED AS THEY CANNOT BE EXCLUDED AS THE CAUSE OF PAIN. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621243 PINN CAN BONE SCREW 6.5MMX25MM HIP OTHER IMPLANT: SCREW NDJ DEPUY ORTHOPAEDICS INC US D00450557

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention