BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 36MM 52OD

    MDR report key: 3052155 · Received April 11, 2013

    Report

    Report Number
    1818910-2013-15210
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 26, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK083642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEPUY CONSIDERS THIS INVESTIGATION CLOSED. 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

    AN S-ROM(A) HIP STEM WAS RETURNED ALONG WITH A MATING 36 MM ULTAMET HEAD AND A 36 MM X 52 MM ULTAMET METAL INSERT FOR EVALUATION. THE DEVICES HAD BEEN EXPLANTED DURING REVISION TOTAL HIP REPLACEMENT SURGERY FOR THE PRESENCE OF A PSEUDO TUMOR. THE COMPLAINT SUMMARY NOTES THAT AN MRI PERFORMED 2 TO 3 YEARS PRIOR TO REVISION SURGERY SHOWED HYDROPS THAT WAS ABOUT THE SIZE OF A FIST. THE ARTICULAR SURFACE OF THE FEMORAL HEAD SHOWED SCRATCHING WITH A WEAR STRIPE NEAR THE POLE THAT SUGGESTS MICROSEPARATION BETWEEN THE HEAD AND LINER IN VIVO. WEAR MARKINGS ON THE ACETABULAR LINER APPEARED UNREMARKABLE. SEVERAL DARKLY STAINED AREAS WERE SEEN ON THE FEMORAL STEM WITHIN THE AREA IN WHICH IT HAD MATED WITH THE FEMORAL SLEEVE. THESE MAY BE THE RESULT OF FRETTING BETWEEN THE STEM AND SLEEVE. THE FEMORAL NECK TAPER SHOWS AREAS OF DISCOLORATION WITH BLACK DEBRIS OR DEPOSITED FILMS SUGGESTIVE OF FRETTING CORROSION DEPOSITS. THE FEMORAL HEAD TAPER ALSO SHOWS BLACK DEPOSITS WITHIN THE TAPER AND AT THE ENTRANCE TO THE MOUTH OF THE TAPER. BOTH WERE ASSIGNED A CORROSION AND FRETTING SCORE OF 4 ACCORDING TO THE GOLBERG CRITERIA. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. 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. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    CONCLUSION AND JUSTIFICATION STATUS: THE ARTICULAR SURFACE OF THE FEMORAL HEAD SHOWED SCRATCHING WITH A WEAR STRIPE NEAR THE POLE THAT SUGGESTS MICROSEPARATION BETWEEN THE HEAD AND LINER IN VIVO. WEAR MARKINGS ON THE ACETABULAR LINER APPEARED UNREMARKABLE. SEVERAL DARKLY STAINED AREAS WERE SEEN ON THE FEMORAL STEM WITHIN THE AREA IN WHICH IT HAD MATED WITH THE FEMORAL SLEEVE. THESE MAY BE THE RESULT OF FRETTING BETWEEN THE STEM AND SLEEVE. THE FEMORAL NECK TAPER SHOWS AREAS OF DISCOLORATION WITH BLACK DEBRIS OR DEPOSITED FILMS SUGGESTIVE OF FRETTING CORROSION DEPOSITS. THE FEMORAL HEAD TAPER ALSO SHOWS BLACK DEPOSITS WITHIN THE TAPER AND AT THE ENTRANCE TO THE MOUTH OF THE TAPER. BOTH WERE ASSIGNED A CORROSION AND FRETTING SCORE OF 4 ACCORDING TO THE GOLBERG CRITERIA. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. ADDENDUM ADDED 24-JANUARY-14. CONCLUSION AND JUSTIFICATION STATUS: FOLLOWING FURTHER INVESTIGATION BY APPLIED RESEARCH AND BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: ROOT CAUSE: UNDETERMINED. IT IS LIKELY IN THIS CASE THAT AN UNKNOWN COMBINATION OF SEVERAL FACTORS OCCURRED ¿ SUCH AS PATIENT FACTORS, SURGICAL PROCEDURE, SURGICAL PROCESS AND IMPLANT DESIGN. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION. IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD FURTHER INFORMATION BE RECEIVED, THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER. 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.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2013, LOT INFORMATION.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO PSEUDOTUMOR .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154850 ULTAMET MTL INS NEUT 36MM 52OD METAL INSERT KWA 8010379 DEPUY INTL., LTD. 2932414

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention