BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5

    MDR report key: 5542036 · Received April 1, 2016

    Report

    Report Number
    0002249697-2016-01038
    Event Type
    Injury
    Date Received
    April 1, 2016
    Date of Event
    March 9, 2016
    Report Date
    June 6, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K121308
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DATE OF IMPLANT UPDATED, CONCOMITANT MEDICAL PRODUCTS,AND DEVICE EVALUATED BY MFR, DEVICE WAS RETURNED FOR EVALUATION. AN EVENT REGARDING DISASSOCIATION INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS CONFIRMED AS A RESULT OF A MAR. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: A VISUAL INSPECTION WAS PERFORMED BY A MATERIAL ANALYSIS ENGINEER WHICH NOTED DAMAGES OBSERVED WERE CONSISTENT WITH THE WEAR MECHANISMS OCCURRING BETWEEN THE FEMORAL HEAD AND THE STEM.[...] DIMENSIONAL INSPECTION: NOT PERFORMED AS DUE TO DAMAGE NOTED IN VISUAL INSPECTION. FUNCTIONAL INSPECTION: NOT PERFORMED AS DUE TO DAMAGE NOTED IN VISUAL INSPECTION. MATERIAL ANALYSIS: A MATERIAL ANALYSIS CONCLUDED [...] THE WEAR MECHANISMS OBSERVED ON THE RETURNED DEVICES IS CONSISTENT WITH LOSS OF TAPER LOCK BETWEEN THE FEMORAL HEAD AND THE HIP STEM TRUNNION. THE ROOT CAUSE OF THE LOSS OF TAPER LOCK WAS NOT ABLE TO BE DETERMINED.[...] -MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE NO INFORMATION WAS PROVIDED. -DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES -COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED CONCLUSION: A MAR CONCLUDED [...] THE WEAR MECHANISMS OBSERVED ON THE RETURNED DEVICES IS CONSISTENT WITH LOSS OF TAPER LOCK BETWEEN THE FEMORAL HEAD AND THE HIP STEM TRUNNION. THE ROOT CAUSE OF THE LOSS OF TAPER LOCK WAS NOT ABLE TO BE DETERMINED [...] NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    THE DR. REVISED AN ACCOLADE I STEM. THE FEMORAL DISENGAGED FROM THE STEM. THE STEMS HAS TRUNION WARE. THE REVISION WAS COMPLETED SUCCESSFULLY WITH A RESMOD STEM AND MDM ON THE CUP SIDE. UPDATE: IT WAS REPORTED THAT PATIENT CALLED LEGAL STATING THAT THE PIN IN HIS LEG THAT CONNECTS TO THE BALL DETERIORATED. ALL METAL PARTS WERE GOING INTO MUSCLE AND HE HAD TO HAVE ANOTHER SURGERY TO HAVE ALL THE DEVICES REMOVED AND REPLACED. THE SURGEON HAD TO CUT INTO HIS BONE AND REMOVE THE HIP.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISASSOCIATION INVOLVING AN ACCOLADE STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE NO INFORMATION WAS PROVIDED. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, OPERATIVE REPORTS, X-RAYS, PATIENT HISTORY & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    THE DR. REVISED AN ACCOLADE I STEM. THE FEMORAL DISENGAGED FROM THE STEM. THE STEMS HAS TRUNION WARE. THE REVISION WAS COMPLETED SUCCESSFULLY WITH A RESMOD STEM AND MDM ON THE CUP SIDE.

    Description of Event or Problem · 1

    THE DR. REVISED AN ACCOLADE I STEM. THE FEMORAL DISENGAGED FROM THE STEM. THE STEMS HAS TRUNION WARE. THE REVISION WAS COMPLETED SUCCESSFULLY WITH A RESMOD STEM AND MDM ON THE CUP SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198144 ACCOLADE (127 DEG) SIZE 3.5 ACCOLADE (127 DEG) SIZE 3.5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 22866301

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R