BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRITANIUM REVISION ACETABULAR

    MDR report key: 4122807 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03619
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K010170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). AN EVENT REGARDING INFECTION AND CUP LOOSENING INVOLVING A TRITANIUM SHELL WAS REPORTED. THE EVENT WAS CONFIRMED. -MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED: " THIS PATIENT¿S CLINICAL PROBLEMS RELATED TO HER LEFT TOTAL HIP ARTHROPLASTY APPEAR TO BE DUE TO A PERIPROSTHETIC INFECTION AND NO RELATED TO FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING OR MATERIALS" -DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT OR STERILE LOT. CONCLUSIONS: A MEDICAL REVIEW WAS PERFORMED AND CONCLUDED THAT THE PATIENTS CLINICAL PROBLEMS WERE RELATED TO AN INFECTION AROUND THE IMPLANT. THERE WAS NO EVIDENCE TO SUGGEST A DEVICE RELATED ISSUE. FURTHER TO THIS CONSULTATION WITH STERILITY ASSURANCE INDICATED THE INTRODUCTION OF THE REPORTED CAUSATIVE AGENT OF THIS POST OPERATIVE INFECTION WAS NOT VIA THE REPORTED DEVICES.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 623-10-32E, TRIDENT 10° X3 INSERT 32MM ID, LOT CODE: KYKMLA , CAT. NO.: 0586-0-032, EXETER. FEMORAL HEAD, LOT CODE: G2073410, CAT. NO.: UNKNOWN, UNKNOWN EXETER STEM, LOT CODE: LOT CODE: UNKNOWN, CAT. NO.: 2080-0030, GAP PLATE SCREWS, LOT CODE: 0LJMLD, CAT. NO.: 2080-0025, GAP PLATE SCREWS, LOT CODE: N0RMNE, CAT. NO.: 080-0020, GAP PLATE SCREWS, LOT CODE: R0AMDE, CAT. NO.: 2080-0015, GAP PLATE SCREWS, LOT CODE: 31111401, AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S EXPERIENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFATURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCING PAIN ON A LEFT HIP. CUP SEEMED LOOSE BUT PATIENT WAS INFECTED AND ALL IMPLANTS WERE REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCING PAIN ON A LEFT HIP. CUP SEEMED LOOSE BUT PATIENT WAS INFECTED AND ALL IMPLANTS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601590 TRITANIUM REVISION ACETABULAR IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH AVEMKE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention