BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP HEAD 10/12 TAPER 28+0 M

    MDR report key: 2955204 · Received February 11, 2013

    Report

    Report Number
    1818910-2013-12140
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 8, 2013
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWY
    PMA / PMN Number
    PK893872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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: AS THERE WERE NO PRODUCTS RETURNED AND NO LOT NUMBERS RECEIVED, NO INVESTIGATION COULD TAKE PLACE AND A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED. IN 2007, A DEAR DOCTOR LETTER WAS ISSUED DUE TO A NUMBER OF COMPLAINTS INVOLVING ULTIMA MOM / TPS STEM COMBINATIONS WHERE THE STEM WAS CORRODING, CAUSING PAIN AND EXTENSIVE PERIPROSTHETIC SOFT TISSUE NECROSIS. IN THIS INSTANCE THERE IS NO MENTION OF STEM CORROSION. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER. DEPUY CONSIDERS THIS INVESTIGATION CLOSED. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION THAT CHANGES THIS CONCLUSION BE RECEIVED, THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    ADDENDUM ADDED 11 NOV 2014: PATIENT PRESENTED WITH PAIN. PATIENT HAD ULTIMA METAL ON METAL TPS STEM. MRI SHOWED FLUID ION HIGH REVISED. AT SURGERY STEM EASILY REMOVED EVIDENCE OF METAL DEBRIS ON STEM AND CEMENT ACETABULUM WELL FIXED. DATE OF PRIMARY SURGERY: UNKNOWN. DATE OF REVISION SURGERY: (B)(6) 2013. UPDATE 28 JULY 2014 - FORMAL CLAIM RECEIVED. MEDICAL RECORDS RECEIVED AND PASSED TO LEEDS ANALYSTS. NOTES CONFIRM REVISION DUE TO ALVAL, METALLOSIS AND LOOSE FEMORAL COMPONENT (PATIENT HAMRS UPDATED) NOTES MENTIONED PATIENT SUFFERED A FALL IN (B)(6) 2006 AND (B)(6) 2009. DOI CONFIRMED, SOME METAL ION LEVELS FOUND AND ADDED BELOW. PRODUCT DETAILS STILL NOT RECEIVED. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODES WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. ADDENDUM ADDED 12-JANUARY-16. PATIENT PRESENTED WITH PAIN. PATIENT HAD ULTIMA METAL ON METAL TPS STEM. MRI SHOWED FLUID ION HIGH REVISED. AT SURGERY STEM EASILY REMOVED EVIDENCE OF METAL DEBRIS ON STEM AND CEMENT ACETABULUM WELL FIXED. DATE OF PRIMARY SURGERY: UNKNOWN. DATE OF REVISION SURGERY: (B)(6) 2013. UPDATE 28 JULY 2014 - FORMAL CLAIM RECEIVED. MEDICAL RECORDS RECEIVED AND PASSED TO LEEDS ANALYSTS. NOTES CONFIRM REVISION DUE TO ALVAL, METALLOSIS AND LOOSE FEMORAL COMPONENT (PATIENT HAMRS UPDATED) NOTES MENTIONED PATIENT SUFFERED A FALL IN (B)(6) 2006 AND (B)(6) 2009. DOI CONFIRMED, SOME METAL ION LEVELS FOUND AND ADDED BELOW. PRODUCT DETAILS STILL NOT RECEIVED. NOV 23 2015 - COMPLAINT REOPENED AS CONFIRMATION OF PRODUCT CODES RECEIVED FROM (B)(6) ON 20 NOV - (B)(6). FOLLOWING RECEIPT OF PRODUCT CODE AND LOT INFORMATION THE COMPLAINT WAS RE-OPENED. A COMPLAINTS DATABASE SEARCH MADE ON PRODUCT LOT 1190551, 1187198 AND 1220513 IDENTIFIED NO PREVIOUS COMPLAINTS. A COMPLAINTS DATABASE SEARCH MADE ON PRODUCT LOT 1193207 IDENTIFIED ONE PREVIOUS COMPLAINT (B)(4). A REVIEW OF (B)(4) IDENTIFIED THAT IT WAS CLOSED WITH AN UNDETERMINED CONCLUSION DUE TO RECEIPT OF INSUFFICIENT INFORMATION. IT WAS CONCLUDED THAT FOLLOWING REVIEW OF THE ADDITIONAL INFORMATION, NO CHANGES WERE REQUIRED TO BE MADE TO THE PREVIOUS INVESTIGATION CONCLUSIONS. DEPUY STILL 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

    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

    THE INVESTIGATION HAS BEEN REOPENED DUE TO RECEIVING PART AND LOT NUMBER. DEPUY WILL NOTIFY THE FDA WHEN THE INVESTIGATION IS COMPLETE. UDI: UNAVAILABLE. 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

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODES WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH PAIN.PATIENT HAD ULTIMA METAL ON METAL TPS STEM. MRI SHOWED FLUID ION HIGH REVISED. AT SURGERY STEM EASILY REMOVED EVIDENCE OF METAL DEBRIS ON STEM AND CEMENT ACETABULUM WELL FIXED.

    Description of Event or Problem · 1

    UPDATE (B)(6) 2014 - FORMAL CLAIM RECEIVED. MEDICAL RECORDS RECEIVED AND PASSED TO LEEDS ANALYSTS. NOTES CONFIRM REVISION DUE TO ALVAL, METALLOSIS AND LOOSE FEMORAL COMPONENT (PATIENT HARMS UPDATED) NOTES MENTIONED PATIENT SUFFERED A FALL IN (B)(6) 2006 AND (B)(6) 2009. DOI CONFIRMED SOME METAL ION LEVELS FOUND AND ADDED BELOW. PRODUCT DETAILS STILL NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58136 HIP HEAD 10/12 TAPER 28+0 M FEMORAL HEAD KWY DEPUY INTERNATIONAL LTD. 8010379 1193207

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention