BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +5

    MDR report key: 4242395 · Received November 11, 2014

    Report

    Report Number
    1818910-2014-31514
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    May 27, 2014
    Report Date
    October 17, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LZO
    PMA / PMN Number
    PK031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. FOLLOW-UP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE LOT NUMBER AND THIS INFORMATION IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    DUE TO NO SIMILAR FAILURES FOUND IN THE DHR REVIEW, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED THROUGH DEPUY CORK¿S INVESTIGATION. A REVIEW OF THE COMPLAINTS DATABASE DID NOT IDENTIFY ANY ANOMALIES. THE RETURNED PRODUCT WAS TRANSFERRED TO APPLIED RESEARCH AND A REPORT WAS RECEIVED STATING THE PRODUCT WAS DESCRIBED BY THE SURGEON AS A 36MM CERAMIC HEAD WITH A + 1.5 OFFSET, HOWEVER FOLLOWING THIS INVESTIGATION AND BACK-TRACING THE LOT NUMBER IT ACTUALLY HAS A + 5 OFFSET. THE ASSOCIATED COMPONENTS USED IN VIVO WERE FROM ZIMMER, MEANING THAT THE COMPATIBILITY OF THE FEMORAL HEAD WITH THE ASSOCIATED COMPONENTS CANNOT BE ASSURED. WITHOUT THE ASSOCIATED COMPONENTS A DEFINITIVE CONCLUSION CANNOT BE MADE AS TO THE CAUSE OF THE PATIENT¿S SYMPTOMS. THE LAB REPORT AND PART WERE TRANSFERRED TO BIOENGINEERING FOR REVIEW. A REPORT WAS RECEIVED ((B)(4) BIOENG REPORT) STATING: THE X-RAY PROVIDED DOES NOT SHOW THE DEPUY PRODUCT (HEAD). IT DOES SHOW THAT THERE WAS A FRACTURE FIXATION PLATE AND MULTIPLE CERCLAGE WIRES IMPLANTED AT THE SAME TIME AS THE STEM. THE HEAD ASSOCIATED WITH THIS COMPLAINT WAS RETURNED FOR REVIEW AND HAS BEEN REVIEWED IN DETAIL WITHIN LAB REPORT (B)(4). FROM THIS REVIEW IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE NEED FOR REVISION. AS DESCRIBED IN THE COMPLAINT DESCRIPTION, THE CERAMIC HEAD HAS A METALLIC APPEARANCE. IT SHOULD BE NOTED THAT THE USE OF DEPUY PRODUCTS WITH OTHER MANUFACTURES PRODUCTS IS CONTRA-INDICATED WITHIN THE DEVICE IFU AND POTENTIALLY CAN RESULT IN A NON-OPTIMAL FIT BETWEEN THE HEAD AND STEM AND OR THE HEAD AND ACETABULAR LINER/CUP. WHILST SOME METAL TRANSFER IS COMMONLY OBSERVED ON RETRIEVED CERAMIC COMPONENTS, THE EXTENT OBSERVED ON THIS COMPLAINT SUGGESTS THERE HAS BEEN AN ADVERSE EVENT WITHIN THE CONSTRUCT. FOR EXAMPLE THE HEAD COULD HAVE DISASSOCIATED FROM THE STEM, THE LINER COULD HAVE DISASSOCIATED FROM THE CUP RESULTING IN THE HEAD ARTICULATING ON THE LINER OR PART OF THE FIXATION DEVICES (PLATE OR CERCLAGE WIRE) COULD HAVE FAILED AND ENDED UP IN THE JOINT SPACE. FROM REVIEW OF THE AVAILABLE INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE. THE MODE OF FAILURE OF THE PROSTHESIS IS MULTI-FACTORIAL AND CONSIDERATION HAS TO BE GIVEN TO ALL OTHER POTENTIAL INFLUENCES SUCH AS, SURGICAL PROCESS, PATIENT VARIABLES I.E. ACTIVITY, WEIGHT, BMI AND USE, ANATOMICAL CONSIDERATIONS AND PATIENT CHANGES OVER TIME. THIS REPORT DETAILS THE FINDINGS FROM A REVIEW OF THE EXPLANTS AND INFORMATION AS SUPPLIED AT THE TIME OF EVALUATION. ANY CONCLUSIONS FROM THIS DATA HAVE TO BE PLACED INTO CONTEXT WITH ALL OTHER RELEVANT FACTORS. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT WILL BE ENTERED INTO THE COMPLAINT DATABASE AND MONITORED THROUGH TREND ANALYSIS.

    Description of Event or Problem · 1

    MALE PATIENT HAVING A PRIMARY SURGERY ON THE (B)(6) 2010, THEY IMPLANTED A DELTA CERAMIC HEAD (36MM +1.5) REFERENCE NUMBER: 136536310. AFTER LESS THAN 4 YEARS, THE STEM PRESENTS LOOSENING SIGNS AND NEEDS TO BE REVISED (PATIENT IN WHEEL CHAIR SINCE THE FIRST PRIMARY SURGERY, SO, HIS LEVEL OF ACTIVITY WAS VERY LIMITED). HE GOES UNDER REVISION SURGERY ON THE (B)(6) 2014. AT THAT POINT THE SURGEONS NOTICED THAT THE DELTA CERAMIC HEAD HAS CHANGED ITS COLOR AND LOOKS LIKE A METAL HEAD IN ALL THE SURFACE EXCEPT IN THE INNER PART. (WE ATTACH THE EXPLANT WITH THIS COMPLAINT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727776 DELTA CER HEAD 12/14 36MM +5 HIP FEMORAL HEAD LZO DEPUY IRELAND 9616671 3169458

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention