BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PAR, RIGHT, W/TRIDENT SIZE F ID

    MDR report key: 8065195 · Received November 13, 2018

    Report

    Report Number
    0002249697-2018-03706
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    August 9, 2018
    Report Date
    November 13, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING DISASSOCIATION INVOLVING A CUSTOM ACETABULAR COMPONENT WAS REPORTED. A MEDICAL REVIEW CONFIRMED DISASSOCIATION OF THE TRIDENT LINER FROM THE CUSTOM ACETABULAR COMPONENT. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: MEDICAL REVIEW OF THE PROVIDED INFORMATION BY A CLINICIAN NOTED THE FOLLOWING: IT WAS REPORTED THAT THE BIPOLAR PORTION OF A CUSTOM SADDLE TYPE PELVIS AND HIP RECONSTRUCTION DEVICE DISSOCIATED REQUIRING REVISION SURGERY. UNDATED X-RAYS DEMONSTRATE THE BIPOLAR LINER DISPLACED FROM THE LOCKING MECHANISM OF A CUSTOM SADDLE PROSTHESIS. PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE MANUFACTURING RECORDS INDICATE THAT ALL DEVICES ACCEPTED INTO FINAL STOCK WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE WERE NO OTHER SIMILAR EVENTS FOR THE LOT PROVIDED. CONCLUSIONS: THE MEDICAL REVIEW CONCLUDED THE FOLLOWING: REVIEW OF THESE RECORDS CONFIRMS THAT DISSOCIATION OF THE BIPOLAR PORTION OF A CUSTOM SADDLE TYPE PELVIS AND HIP RECONSTRUCTION DEVICE OCCURRED, HOWEVER, THE ROOT CAUSE CANNOT BE DETERMINED AS INSUFFICIENT INFORMATION WAS AVAILABLE. DOCUMENTATION WHICH WOULD AID IN THE FURTHER COMPLETION OF THIS ASSESSMENT WOULD INCLUDE: OPERATIVE REPORTS; SURGICAL IMPLANT RECORDS FROM THE SURGERIES. DATED PRE AND POST OP X-RAYS/ IMAGING FROM THE INDEX AND REVISION SURGERIES; OUTPATIENT OFFICE/CLINIC NOTES; IMPLANT RETRIEVAL WITH MATERIAL ANALYSIS. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO DISASSOCIATION. PATIENT REPORTED HE SAT IN A LOW CHAIR AND STRAINED TO GET UP. SURGEON REPORTED THAT THE BIPOLAR HEAD OF THE CONSTRAINED LINER DISASSOCIATED AS A RESULT. CONTRIBUTING FACTOR REPORTED WAS THE 40MM EXTENSION PIECE HAD BEEN IMPINGING ON THE CONSTRAINED LINER AND CONTRIBUTED TO LEVERING THE BIPOLAR HEAD OUT OF THE ASSEMBLY. A CERAMIC HEAD, CONSTRAINED LINER, AND 40MM EXTENSION PIECE WERE REVISED TO A METAL HEAD, CONSTRAINED LINER (SAME CATALOG NUMBER), AND A 40MM EXTENSION PIECE FROM A DIFFERENT CUSTOM SADDLE KIT WHICH HADN'T BEEN USED PREVIOUSLY (CUSTOM SADDLE KITS COME WITH SEVERAL EXTENSION PIECES - 40, 50, AND 60 MM. NOT ALL MAY BE USED IN SURGERY. UNUSED EXTENSION PIECES ARE RETAINED BY THE HOSPITAL FOR POSSIBLE FUTURE USE IF THE IMPLANTS HAVE NOT EXPIRED. SURGEON WAS MADE AWARE THE USE OF AN EXTENSION PIECE FROM ANOTHER CUSTOM SADDLE KIT WAS OFF-LABEL AND ELECTED TO CONTINUE). UPDATE 16 OCTOBER, 2018: MEDICAL REVIEW BY A CLINICIAN CONFIRMED "DISSOCIATION OF THE BIPOLAR PORTION OF A CUSTOM SADDLE TYPE PELVIS AND HIP RECONSTRUCTION DEVICE OCCURRED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904550 PAR, RIGHT, W/TRIDENT SIZE F ID CUSTOM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 292NRH

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R