BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_TIBIAL BASEPLATE

    MDR report key: 16534993 · Received March 13, 2023

    Report

    Report Number
    0002249697-2023-00247
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    January 3, 2023
    Report Date
    April 20, 2023
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    UDI-DI
    07613327050431
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING MALPOSITION INVOLVING AN UNKNOWN BASEPLATE WAS REPORTED. THE EVENT WAS CONFIRMED AS THE REVIEW OF THE MEDICAL RECORDS CONCLUDED: 'THERE WAS AN X-RAY THAT DID SHOW TIBIAL MALPOSITION WITH MARKED POSTERIOR SLOPE AND APPARENT SUBLUXATION.' METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: MATERIAL ANALYSIS, VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED. CLINICIAN REVIEW:A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT INDICATED: NARRATIVE: THERE WAS A REPORTED REVISION SURGERY OF INSTABILITY OF A TKA. THERE WERE NO MEDICAL RECORDS DOCUMENTING THE PATIENT¿S CONDITION PRE OR POSTOPERATIVE COURSE OR EXAM. THERE WERE RECORDS SHOWING THAT A PRIMARY KNEE WAS PERFORMED. X-RAYS PRIOR TO THE IMPLANT SHOWED MEDIAL COMPARTMENTAL OA. A TKA WAS PERFORMED WITH TRIATHLON UNCEMENTED IMPLANTS. THERE WERE XRAYS APPROXIMATELY 5 YEARS LATER SHOWING THE UNCEMENTED COMPONENTS WITHOUT APPARENT LOOSENING BUT MARKED TIBIAL POSTERIOR SLOPE ON THE LATERAL AND POSSIBLY SUBLUXATION ON THE AP. A CHANGE IN POSITION CANNOT BE DETERMINED WITHOUT INTERVAL X-RAYS. AN OPERATIVE NOTE WAS PROVIDED DOCUMENTING REVISION SURGERY FOR INSTABILITY BUT NO ADDITIONAL DETAILS AS TO THE PATIENT CONDITION OR EXAM. A TRIATHLON STEMMED TS COMPONENT WAS PLACE WITH CEMENT. NO POSTOPERATIVE COURSE WAS PROVIDED FOR REVIEW. CONCLUSION/ASSESSMENT: REVISION KNEE PERFORMED FOR REPORTED INSTABILITY IN AN UNCEMENTED TRIATHLON KNEE WITH MALPOSITION. EVENT CONFIRMATION: A REVISION SURGERY CAN BE CONFIRMED. ROOT CAUSE: THE ROOT CAUSE OF THE REVISION WAS REPORTED TO BE INSTABILITY. THERE WAS AN X-RAY THAT DID SHOW TIBIAL MALPOSITION WITH MARKED POSTERIOR SLOPE AND APPARENT SUBLUXATION. PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS THE DEVICE LOT DETAILS WERE NOT PROVIDED. CONCLUSIONS: THE EVENT WAS CONFIRMED AS THE REVIEW OF THE MEDICAL RECORDS CONCLUDED: 'THERE WAS AN X-RAY THAT DID SHOW TIBIAL MALPOSITION WITH MARKED POSTERIOR SLOPE AND APPARENT SUBLUXATION.' NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED. H3 OTHER TEXT : DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 0

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED: KNEE REVISION DUE TO INSTABILITY. UPDATE 23 MAR 2023 - BASED ON THE CONCLUSION OF THE MEDICAL REVIEW, THE CLINICIAN STATED: 'THE ROOT CAUSE OF THE REVISION WAS REPORTED TO BE INSTABILITY. THERE WAS AN X-RAY THAT DID SHOW TIBIAL MALPOSITION WITH MARKED POSTERIOR SLOPE AND APPARENT SUBLUXATION.'

    Description of Event or Problem · 0

    THE FOLLOWING WAS REPORTED: KNEE REVISION DUE TO INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015238 UNKNOWN_TIBIAL BASEPLATE PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH 5530-G-309 UNKNOWN 07613327050431

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization| R