BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CONSTRAINED INSERT 22E

    MDR report key: 4221781 · Received November 3, 2014

    Report

    Report Number
    0002249697-2014-04162
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 13, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A TRIDENT LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: NOT PERFORMED AS THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. 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: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT. IF FURTHER INFORMATION BECOMES AVAILABLE OR THE PRODUCT IS RETURNED, THIS INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICES LISTED IN THIS REPORT: CAT 6276-1-025, 25MM MOD, REV HIP BODY/BOLT STD COMPONENT LEVEL 9006-1-025, LOT CODE 44785306. CAT 6260-9-122, 22.2MM STD, LFIT V40 HEAD LOT CODE 37069302. 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 DEVICES ARE NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT CAME TO ER WITH SWOLLEN LEFT DISTAL INCISION SITE, ER DOCTORS ULTRA SOUNDED AND FOUND A POCKET OF FLUID, ER DOCTORS DECIDED TO DRAIN WOUND BY LANCING THE SURGERY SITE TO RELEASE FLUID, ER DOCTORS INFORMED HER ORTHOPEDIC DOCTOR AND SHE DROVE HERSELF TO (B)(6), PT ADMITTED TO SURGERY TO DO ANOTHER INCISION AND DRAINAGE, PT BROUGHT TO SURGERY, PT OPENED UP, SEVERAL CULTURES TAKEN FROM HIP, BIPOLAR KEY USED TO REMOVE FEMORAL HEAD OUT OF THE CONSTRAINED LINER, METAL DIS IMPACTED FROM RESTORATION STEM, CONSTRAINED LINER REMOVED WITH OSTEOTOME, PT THEN WAS IRRIGATED WITH 12000CC OF SALINE INFUSED WITH BACITRACIN AND IODINE, NEW CONSTRAINED LINER WAS PUT INTO ACTETABULAR SHELL AND IMPACTED, DR NOTICED VERSION ON CONE BODY WAS NOT APPROPRIATE, THE SCREW INSIDE THE CONE WAS NOT TIGHT, DR REMOVED SCREW, USED CONE STEM SEPARATOR TO DISIMPACTE CONE BODY FROM DISTAL STEM, PUT IN NEW CONE BODY WITH BETTER ANIVERSION AND IMPACTED, HAND TIGHTENED SCREW THEN USED TORQUE WRENCH FOR FINAL INSERTION, NEW FEMORAL IMPACTED, FEMORAL HEAD INSERTED INTO CONSTRAINED LINER, PT CLOSED IN NORMAL FASHION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT CAME TO ER WITH SWOLLEN LEFT DISTAL INCISION SITE, ER DOCTORS ULTRA SOUNDED AND FOUND A POCKET OF FLUID, ER DOCTORS DECIDED TO DRAIN WOUND BY LANCING THE SURGERY SITE TO RELEASE FLUID, ER DOCTORS INFORMED HER ORTHOPEDIC DOCTOR AND SHE DROVE HERSELF TO ADVENTIST IN PORTLAND, PT ADMITTED TO SURGERY TO DO ANOTHER INCISION AND DRAINAGE, PT BROUGHT TO SURGERY, PT OPENED UP, SEVERAL CULTURES TAKEN FROM HIP, BIPOLAR KEY USED TO REMOVE FEMORAL HEAD OUT OF THE CONSTRAINED LINER, METAL DIS IMPACTED FROM RESTORATION STEM, CONSTRAINED LINER REMOVED WITH OSTEOTOME, PT THEN WAS IRRIGATED WITH 12000CC OF SALINE INFUSED WITH BACITRACIN AND IODINE, NEW CONSTRAINED LINER WAS PUT INTO ACETABULAR SHELL AND IMPACTED, DR NOTICED VERSION ON CONE BODY WAS NOT APPROPRIATE, THE SCREW INSIDE THE CONE WAS NOT TIGHT, DR REMOVED SCREW, USED CONE STEM SEPARATOR TO DISIMPACTED CONE BODY FROM DISTAL STEM, PUT IN NEW CONE BODY WITH BETTER ANIVERSION AND IMPACTED, HAND TIGHTENED SCREW THEN USED TORQUE WRENCH FOR FINAL INSERTION, NEW FEMORAL IMPACTED, FEMORAL HEAD INSERTED INTO CONSTRAINED LINER, PT CLOSED IN NORMAL FASHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703701 TRIDENT 0 DEG CONSTRAINED INSERT 22E IMPLANT KWZ STRYKER ORTHOPAEDICS-MAHWAH MNKE8N

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention