BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 10° X3 INSERT 32MM ID

    MDR report key: 7267005 · Received February 13, 2018

    Report

    Report Number
    0002249697-2018-00400
    Event Type
    Injury
    Date Received
    February 13, 2018
    Date of Event
    June 14, 2016
    Report Date
    April 3, 2018
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K033716
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: A DEVICE LISTED WAS CORRECTED; MANUFACTURING DATE TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; CAT# 502-11-54E; LOT#17040901. AN EVENT REGARDING PAIN INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS CONFIRMED THROUGH THE MEDICAL RECORDS. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: NOT PERFORMED AS PRODUCT WAS NOT RETURNED, IT REMAINS IMPLANTED MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENT: [...] THE CRF FORMS DOCUMENT INDEED THAT THE PATIENT HAD SLIGHT OCCASIONAL PAIN AT LONG WALKS REQUIRING A CANE UNDER SUCH CONDITIONS. [...] THERE IS NO OBVIOUS EXPLANATION FOR THE CAUSE OF THE PROBLEM. THERE ARE X-RAYS FROM EARLY PRE-OP TO 10-YEARS THAT DOCUMENT A VERY ADEQUATE IMPLANTATION OF COMPONENTS, STEM AND CUP, WITH SATISFACTORY COMPONENT POSITIONS, STABLE BONE INGROWTH CONDITIONS WITH NO CHANGES OVER TIME OTHER THAN THE USUAL BONE REMODELING. NO POLY WEAR, OSTEOLYSIS, ECTOPIC BONE FORMATION OR OTHER ADVERSE SIGNS POTENTIALLY POINTING TO TROUBLE. SO, ALSO FROM THE X-RAY PERSPECTIVE A VERY ADEQUATE RESULT. WE HAVE TO REMEMBER THIS PATIENT WAS 85-YEAR OLD AT TIME OF EVALUATION AT 10-YEARS FOLLOW-UP. HER MEDICAL CONDITION HAD SLIGHTLY DECREASED AND IT WOULD NOT BE IMPOSSIBLE THAT AGE RELATED MUSCULAR ATROPHY WOULD PLAY A ROLE IN THE CURRENT SYMPTOMS. THIS WOULD REPRESENT A SATISFACTORY EXPLANATION ALTHOUGH THERE IS NO SUBSTANTIAL EVIDENCE TO PROVE THIS. AS SUCH REMAINS CAUSE OF THE COMPLAINTS UNCLEAR ALTHOUGH THERE ARE CERTAINLY NO DEVICE-RELATED FACTORS INVOLVED. QUITE LIKELY, BY EXCLUSION OF PROCEDURE-RELATED FACTORS REGARDING DEVICE FUNCTIONALITY, ROOT CAUSE WOULD BE PATIENT-RELATED WITH REGARD TO AGE-RELATED DECREASE IN MUSCLE QUALITY ALTHOUGH FACTUAL EVIDENCE IS MISSING. MORE INFORMATION WOULD BE REQUIRED TO FURTHER DETAIL THIS CASE. PRODUCT HISTORY REVIEW: INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE REPORTED EVENT OF PAIN WAS CONFIRMED BASED ON THE MEDICAL RECORDS PROVIDED. CLINICIAN REVIEW OF THE MEDICAL RECORDS THAT WERE PROVIDED CONCLUDED THAT MORE INFORMATION WOULD BE REQUIRED TO FURTHER DETAIL THIS CASE. ADDITIONAL INFORMATION SUCH AS MORE RECENT MEDICAL RECORDS ARE NEEDED TO FURTHER EVALUATE. PAIN CAN OCCUR POST-OPERATIVELY FOR A NUMBER OF REASONS AND IS A SYMPTOM RATHER THAN THE CAUSE OF THE ISSUE THE PATIENT IS EXPERIENCING. NO FURTHER INVESTIGATION IS POSSIBLE 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 PATIENT IS ENROLLED IN THE TRIDENT X3 CLINICAL STUDY AND DURING THE 10 YEARS POSTOP QUESTIONNAIRE SHE NOTED SHE STILL HAD PAIN AND WHEN ASKED THE QUESTION IF SHE WAS SATISFIED WITH THE SURGERY, SHE SAID SHE WAS NOT.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: SECUR-FIT HA 132 HIP STEM #8; CAT#6051-0830A; LOT#372661203. C-TAPER COCR LFIT HEAD 32MM/+5; CAT#06-3205; LOT#38450304. TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL; CAT3502-11-54E; LOT#17040901. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Description of Event or Problem · 1

    THE PATIENT IS ENROLLED IN THE (B)(6) CLINICAL STUDY AND DURING THE 10 YEARS POSTOP QUESTIONNAIRE SHE NOTED SHE STILL HAD PAIN AND WHEN ASKED THE QUESTION IF SHE WAS SATISFIED WITH THE SURGERY, SHE SAID SHE WAS NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112020 TRIDENT 10° X3 INSERT 32MM ID PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 33066101

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other