BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX 127 #11

    MDR report key: 3910590 · Received July 2, 2014

    Report

    Report Number
    0002249697-2014-02515
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    October 1, 2013
    Report Date
    June 9, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K051738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN LEFT STRYKER HIP.AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING INCORRECT IMPLANT SELECTION LEADING TO PAIN AND HYPERPLASIA INVOLVING A SECUR-FIT MAX STEM WAS REPORTED. THE EVENT WAS NOT CONFIRMED. A REVIEW OF PROVIDED RECORDS PERFORMED BY A CONSULTING CLINICIAN INDICATED: "ON (B)(6) 2013 A TIBIAL STRUT ALLOGRAFT OF THE LEFT FEMORAL SHAFT WAS PERFORMED FOR A DIAGNOSIS OF STRESS INDUCED HYPERPLASIA OF THE LEFT FEMORAL SHAFT WITH THIGH PAIN. [...] THERE IS NO RADIOGRAPHIC CONFIRMATION OF THE DIAGNOSIS OF STRESS INDUCED HYPERPLASIA OF THE FEMUR SECONDARY TO THE FEMORAL COMPONENTS, BUT THE APPARENT RELIEF OF THIGH PAIN AFTER THE ALLOGRAFT SURGERY WOULD APPEAR TO CONFIRM THE DIAGNOSIS. THERE IS NO REASON TO CONCLUDE THAT ANY UNIQUE FACTORS OF PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS OF THE STRYKER COMPONENTS WERE RESPONSIBLE FOR THIS CLINICAL SITUATION.¿ DEVICE HISTORY REVIEW: THE REPORTED DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE MEDICAL REVIEW INDICATED THAT THE RELIEF OF THIGH PAIN AFTER THE ALLOGRAFT SURGERY INDICATES THERE WAS STRESS INDUCED HYPERPLASIA. HOWEVER, THERE IS NO INDICATION THAT THE STEM WAS TOO LONG CAUSING THE STRESS. WITH THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THE EVENT IS DEVICE RELATED. THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: TRIDENT PSL HA CLUSTER 54MM; CAT# 542-11-54F; LOT# MLEAWH. TRIDENT 10° X3 INSERT 36MM ID; CAT# 623-10-36F; LOT# MKRRHY. DELTA C-TAPER HEAD 36MM +5; CAT# 18-3605; LOT# 39214801. D-M 2.0MM BEADED CABLE SET SS; CAT# 3704-0-050; LOT# 42587002. D-M 2.0MM BEADED CABLE SET SS; CAT# 3704-0-050; LOT# 40069607. 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

    IT WAS REPORTED THAT THE PATIENT IS STILL IN CONSTANT PAIN AFTER REVISION SURGERY. PATIENT IS ON PAIN KILLER AND STILL WALKS ON CRUTCHES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS STILL IN CONSTANT PAIN AFTER REVISION SURGERY. PATIENT IS ON PAIN KILLER AND STILL WALKS ON CRUTCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388199 SECUR-FIT MAX 127 #11 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MKH260

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other