BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM -2

    MDR report key: 3077326 · Received April 25, 2013

    Report

    Report Number
    1818910-2013-15952
    Event Type
    Injury
    Date Received
    April 25, 2013
    Date of Event
    November 5, 2010
    Report Date
    November 29, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    PMA / PMN Number
    PK980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FOUND ADDITIONAL SIMILAR REPORTING AGAINST THE 2132499 LOT CODE. A REVIEW OF DEVICE HISTORY RECORDS FOUND NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE SEARCH OF THE COMPLAINTS DATABASES FOUND NO ADDITIONAL SIMILAR REPORTS AGAINST THE REMAINING PRODUCT/LOT CODE COMBINATIONS. NO ADDITIONAL INFORMATION WAS MADE AVAILABLE TO CUSTOMER QUALITY. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT HAS BEEN REOPENED.

    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

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES Y55A91000, 2125481, 2140612, AH6EH1000, AB3B44000, AND Z88B84000. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2132499 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. REVIEW OF PROVIDED PATIENT X-RAYS FINDS THE CUP IS NOTED ON THE X-RAYS AS STEEP AND THIS IS REPORTED IN THE CLINICAL CORRESPONDENCE AS 70DEG. IT IS LIKELY THIS CONTRIBUTED TO THE NEED FOR REVISION BUT IT IS NOT POSSIBLE TO CONFIRM HIGH WEAR WITHOUT THE DEVICE. THE SQUEAKING AND GRINDING SENSATION MAY BE DUE TO THE STEEP CUP ANGLE LEADING TO MIXED OR BOUNDARY LUBRICATION, AGAIN WITHOUT THE IMPLANT IT IS NOT POSSIBLE TO CONFIRM THIS ABSOLUTELY. IT WOULD SEEM UNLIKELY THAT THE NEED FOR REVISION WAS DUE TO DEVICE. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM (B)(6). CONFIRMED REVISION OF PINNACLE IMPLANTS. REASON NOT PROVIDED, REVISION DATE CONFIRMED. DOI -(B)(6) 2006. UPDATE JULY 2 2013: IN 2008 PATIENT BECAME AWARE OF SQUEAKING SENSATION IN THE LEFT HIP WHICH PROGRESSIVELY BECAME WORSE. HE ALSO BECAME AWARE OF A GRINDING SENSATION WITHIN THE GROIN AND A BURNING SENSATION AROUND THE LEFT HIP SCAR. THE REVISION TOOK PLACE ON THE (B)(6) 2010, DURING WHICH THERE WAS CLEAR EVIDENCE OF METALLOSIS AROUND THE LEFT HIP. REOPENED - (B)(6) 2013 - DEMS, SURGERY NOTES, CORRESPONDENCE AND PATHOLOGY REPORT RECEIVED FROM HOSPITAL. X-RAYS RE-REQUESTED. DETAILS ATTACHED. THE REPORTED EVENT HAS BEEN EVALUATED AND WILL BE MONITORED. 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

    (B)(4). COMPLAINT DESCRIPTION; DOI; PRODUCT/LOT. REVISED FOR NOISE AND METALLOSIS FOUND.

    Description of Event or Problem · 1

    UPDATE(B)(4) 2013: PATIENT DEMS; SURGERY NOTES; PATHOLOGY REPORT; CLINICAL CORRESPONDENCE

    Description of Event or Problem · 1

    CONFIRMED REVISION OF PINNACLE IMPLANTS. REASON NOT PROVIDED, REVISION DATE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180472 ARTICULEZE M HEAD 36MM -2 HIP FEMORAL HEAD JDI DEPUY INTERNATIONAL LTD. 8010379 2125481

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention