BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S-ROM*PIN LOCK,5.0MM DIA

    MDR report key: 3191372 · Received June 26, 2013

    Report

    Report Number
    1818910-2013-19934
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 2013
    Manufacturer
    1219655 DEPUY-RAYNHAM
    Product Code
    JDI
    PMA / PMN Number
    PK963206
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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

    CONCLUSION AND JUSTIFICATION STATUS: CONCLUSION AND JUSTIFICATION STATUS: THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. A COMPLAINT SEARCH AND A REVIEW OF THE MANUFACTURING RECORDS WERE CARRIED OUT. NO ANOMALIES OR PREVIOUS COMPLAINTS WERE FOUND RELATING TO THE PROVIDED LOT NUMBER. THE RETURNED X-RAYS AND SURGICAL NOTES WERE REVIEWED BY OUR BIOENGINEERS WHO CONCLUDED AS FOLLOWS: ROOT CAUSE: UNDETERMINABLE, WEAR OF THE POLYETHYLENE HAS OCCURRED AND THIS IS NOT UNEXPECTED GIVEN THE LENGTH OF TIME THE DEVICE HAS BEEN IN THE BODY. THIS WAS A REVISION PROCEDURE WHERE THERE IS A HIGHER RISK OF REVISION THAN FOR A PRIMARY. OSTEOLYSIS IS REPORTED. IT IS UNLIKELY THERE IS A MANUFACTURING FAULT AS THE DEVICE LASTED 18 YEARS. IT IS LIKELY IN THIS CASES THAT AN UNKNOWN COMBINATION OF SEVERAL FACTORS OCCURRED ¿ SUCH AS PATIENT FACTORS, SURGICAL PROCEDURE, SURGICAL PROCESS AND IMPLANT DESIGN. SHOULD ADDITIONAL INFORMATION BE RECEIVED THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Description of Event or Problem · 1

    PATIENT PRESENTED IN 2013 WITH PAIN. XRAYS SHOWED POLYETHYLENE LINER WEAR. HIP SHOWED SIGNS OF POLYETHYLENE DISEASE (OSTEOLYSIS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291246 S-ROM*PIN LOCK,5.0MM DIA PIN LOCK JDI 1219655 DEPUY-RAYNHAM SA102489

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention