BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM

    MDR report key: 6518504 · Received April 25, 2017

    Report

    Report Number
    0002249697-2017-01361
    Event Type
    Injury
    Date Received
    April 25, 2017
    Date of Event
    March 29, 2017
    Report Date
    August 9, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K143085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 6051-0730S, SECUR-FIT MAX 132 HIP STEM #7, LOT CODE: MJM0V1; CAT. NO.: 2030-6530-1, 6.5 CANCELLOUS BONE SCREW 30MM, LOT CODE: MHT8DX; CAT. NO.: 18-2825, DELTA C-TAPER HEAD 28MM +2.5, LOT CODE: 3297320; CAT. NO.: 623-10-28D, TRIDENT 10° X3 INSERT 28MM ID, LOT CODE: MJMJ2R. AN EVENT REGARDING PAIN INVOLVING A TRIDENT SHELL WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: THE PROVIDED MEDICAL INFORMATION WAS SUBMITTED TO A CONSULTING CLINICIAN WHO INDICATED: " NO PRIMARY HARM WAS EVIDENT IN THIS ASSESSMENT. AT HER LAST REPORTED FOLLOWUP EXAMINATION SHE WAS RECOVERING WELL WITH PAINLESS RANGE OF MOTION ON PHYSICAL EXAMINATION. X-RAYS TAKEN AT THAT TIME SHOWED THE THA IMPLANTS TO BE IN ANATOMIC POSITION WITHOUT EVIDENCE OF LOOSENING OR MECHANICAL COMPLICATION." DEVICE HISTORY REVIEW: DEVICE HISTORY REVIEW INDICATED THE DEVICES ACCEPTED INTO FINAL STOCK FROM THE REPORTED LOT WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAS BEEN NO OTHER EVENT FOR THE LOT REFERENCED. CONCLUSIONS: THE REPORTED EVENT NOR ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. HOWEVER, THE MEDICAL REVIEW CONCLUDED, ¿NO PRIMARY HARM WAS EVIDENT IN THIS ASSESSMENT. AT HER LAST REPORTED FOLLOWUP EXAMINATION SHE WAS RECOVERING WELL WITH PAINLESS RANGE OF MOTION ON PHYSICAL EXAMINATION. XRAYS TAKEN AT THAT TIME SHOWED THE THA IMPLANTS TO BE IN ANATOMIC POSITION WITHOUT EVIDENCE OF LOOSENING OR MECHANICAL COMPLICATION." PRODUCT RECALL VERIFICATION RESPONSE CONFIRMED THAT NONE OF THE REPORTED DEVICES WERE PART OF THE RECALL. 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 FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: DEVICE NAME SECURFIT #7 STEM; CAT# UNKNOWN; LOT# UNKNOWN. DEVICE NAME 6.5X30MM CANCELLOUS BONE SCREW; CAT# UNKNOWN; LOT# UNKNOWN. DEVICE NAME BIOLOX HEAD 28MM+2.5MM; CAT# UNKNOWN; LOT# UNKNOWN. DEVICE NAME X329MM INSERT; CAT# UNKNOWN; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT STATED SHE HAS BEEN SUFFERING FOR 6 YEARS WITH PAIN AFTER RIGHT HIP IMPLANT ON (B)(6) 2011. SHE STATED ISSUES STANDING, WALKING AND SITTING FEELS LIKE IT CATCHES, ALSO A TISSUE TEARING PAIN.

    Description of Event or Problem · 1

    PATIENT STATED SHE HAS BEEN SUFFERING FOR 6 YEARS WITH PAIN AFTER RIGHT HIP IMPLANT ON (B)(6) 2011. SHE STATED ISSUES STANDING, WALKING AND SITTING FEELS LIKE IT CATCHES, ALSO A TISSUE TEARING PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299790 PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 50MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH MJP8HN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other