BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX 132 HIP STEM #9

    MDR report key: 2925375 · Received January 22, 2013

    Report

    Report Number
    0002249697-2013-00147
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 17, 2012
    Report Date
    January 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K051738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER RIGHT HIP.AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4): NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) INCHES IN HEIGHT. AN EVENT REGARDING AN INFECTION AND ILIOPSOAS TENDINITIS INVOLVING A SECUR-FIT MAX 132 HIP STEM #9 WAS REPORTED. THE INFECTION WAS NOT CONFIRMED. THE ILIOPSOAS TENDINITIS WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED MEDICAL RECORDS CONCLUDED THERE IS NO INDICATION OF FAULTY PROSTHETIC COMPONENTS. DEVICE HISTORY REVIEW: A DEVICE HISTORY REVIEW CONFIRMED ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW CONFIRMED OTHER EVENTS FOR THE REPORTED STERILE LOT. CONCLUSIONS: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT CONCLUDED THAT THERE IS NO INDICATION OF FAULTY PROSTHETIC COMPONENTS. THE REVIEW ALSO CONCLUDED THAT THE ILIOPSOAS TENOTOMY WAS NOT RELATED TO THE DEVICES. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE OF A LACK OF INFORMATION. THERE IS NO DOCUMENTATION OF INFECTION AS NOTED IN THE EVENT DESCRIPTION, NO DOCUMENTATION OF REVISION SURGERY OTHER THAN ILIOPSOAS TENOTOMY NOT INVOLVING THE PROSTHETIC COMPONENTS, AND NO DOCUMENTATION REGARDING THE DISLOCATION AND REDUCTION OF THE RIGHT TOTAL HIP ARTHROPLASTY AS NOTED ON THE X-RAYS. FURTHER INFORMATION REGARDING THESE EVENTS IS NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING THE ROOT CAUSE. THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: TRIDENT PSL HA SOLID BACK 56MM; CAT# 540-11-56F; LOT# 35549001. UNI ADAPTOR SLEEVE C TAPER TI; CAT# 19-0000T; LOT# 35912504. TRIDENT 0 DEG INSERT 40MM; CAT# 623-00-40F; LOT# MHNH29. DELTA UN.FEM HD 40MM R40 16/18; CAT# 6519-1-040; LOT# 35796905. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: THE PATIENT STATES THAT HE HAD BEEN IN CONSTANT PAIN SINCE THE INITIAL IMPLANT SURGERY. PATIENT'S PAIN WAS WORSE AFTER THE IMPLANT THAN WITH HIS ORIGINAL CONDITION. SURGEON DECIDED TO PERFORM A REVISION SURGERY AND IT WAS DISCOVERED DURING THIS SURGERY THAT THE PATIENT HAD AN INFECTION. THE PATIENT HAS SPOKEN WITH AN ATTORNEY.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: THE PATIENT STATES THAT HE HAD BEEN IN CONSTANT PAIN SINCE THE INITIAL IMPLANT SURGERY. PATIENT'S PAIN WAS WORSE AFTER THE IMPLANT THAN WITH HIS ORIGINAL CONDITION. SURGEON DECIDED TO PERFORM A REVISION SURGERY AND IT WAS DISCOVERED DURING THIS SURGERY THAT THE PATIENT HAD AN INFECTION. THE PATIENT HAS SPOKEN WITH AN ATTORNEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30730 SECUR-FIT MAX 132 HIP STEM #9 IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH MHND24

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention