BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFC*SIGMA C/R NPOR FE RT SZ2.5

    MDR report key: 3362601 · Received September 23, 2013

    Report

    Report Number
    1818910-2013-28170
    Event Type
    Malfunction
    Date Received
    September 23, 2013
    Date of Event
    September 14, 2013
    Report Date
    September 16, 2013
    Manufacturer
    DEPUY IRELAND
    Product Code
    JWH
    PMA / PMN Number
    PK943462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DUE TO NO SIMILAR FAILURES FOUND IN THE DHR REVIEW, RETURNED PRODUCT MEETING SPECIFICATION, AND NO SIMILAR COMPLAINTS WITHIN A 4 YEAR PERIOD, THE COMPLAINT CANNOT BE CONFIRMED. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. SHOULD FURTHER INFORMATION COME AVAILABLE THAT IMPACTS THE FINDINGS IN THIS INVESTIGATION IT WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE INITIAL INFORMATION AND AVAILABLE INVESTIGATIVE INPUTS FINDS THE REPORT HAS BEEN INADVERTENTLY FILED AS A SERIOUS INJURY. THE TYPE OF REPORTABLE EVENT HAS BEEN CHANGED TO MALFUNCTION. A BACK-UP PRODUCT WAS AVAILABLE AND USED WITH NO DELAY TO SURGERY AND NO IMPACT TO PATIENT. 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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICE AND PACKAGING CONFIRMS THE REPORTED POROUS COATED FEMORAL COMPONENT PACKAGED AND LABELED AS A CEMENTED FEMORAL COMPONENT. PRODUCT TAMPERING HAS BEEN CONFIRMED. A COUNTERFEIT LABEL MADE BY PHOTOCOPYING A LABEL FROM ANOTHER DEPUY PRODUCT (96-0018/3043074) HAS BEEN APPLIED OVER A PRIMARY LABEL (96-008/3245665) ON THE PROVIDED PACKAGING. VISUAL EXAMINATION OF THE RETURNED 96-00038 DEVICE FINDS AN ABNORMAL FINISH PRESENT FOR THE DEVICE. SURFACE SCRATCHES ARE PRESENT ON THE ENTIRETY OF THE ARTICULATING SURFACE. THE SCRATCHING IS DESCRIBED AS ¿SWIRLED¿ AND APPEARS TO HAVE BEEN A MANUAL POLISH. PRODUCT TAMPERING HAS ALSO BEEN CONFIRMED WITH THE INNER PACKAGING. A SEARCH OF THE COMPLAINTS DATABASES AGAINST THE THREE INVOLVED PRODUCT/LOT CODE COMBINATIONS FINDS NO OTHER REPORTS. THE EVENT IS CONSIDERED ISOLATED. DEVICE HISTORY RECORDS REVIEW AND LOT TRACE WERE PERFORMED WITH NO RELATED ANOMALIES FOUND. THE COMPLAINT HAS BEEN IDENTIFIED FOR FURTHER INVESTIGATION BY DEPUY BRAND PROTECTION. 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

    REVIEW OF THE INITIAL INFORMATION AND AVAILABLE INVESTIGATIVE INPUTS FINDS THE REPORT HAS BEEN INADVERTENTLY FILED AS A SERIOUS INJURY. THE TYPE OF REPORTABLE EVENT HAS BEEN CHANGED TO MALFUNCTION. ISOLATED PRODUCT TAMPERING IS SUSPECTED AS IT IS NOW KNOWN A DELIBERATE ATTEMPT TO FALSIFY PACKAGING AND LABELING HAS OCCURRED. THE INVESTIGATION IS ONGOING AND FURTHER IN-DEPTH ANALYSIS TO ASSIST IN THE DETERMINATION OF THE ROOT CAUSE IS BEING PERFORMED. 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

    THE COMPONENT WAS PROPERLY PACKED FROM OUTSIDE, BUT THE INTERNAL PACKING WAS COMPROMISED. THE PRODUCT STICKERS WERE MISSING. THE CONDITION SHOWED THAT IT WAS RE STERILIZED AND RE PACKED. MOREOVER, THE MOST STRANGE THING WAS THAT THE FEMORAL COMPONENT WAS UNCEMENTED AND WITH THE BEST OF MY KNOWLEDGE WE NEVER IMPORTED THIS IN OUR MARKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479349 PFC*SIGMA C/R NPOR FE RT SZ2.5 FEMORAL COMPONENT JWH DEPUY IRELAND 3043074

    Patients

    Seq Age Sex Outcome Treatment
    1 Other