BEUDAMED
    FDA Adverse Event Death Summary report: N

    X3 TRIATHLON CS INS SIZE4 16MM

    MDR report key: 5293618 · Received December 14, 2015

    Report

    Report Number
    0002249697-2015-04231
    Event Type
    Death
    Date Received
    December 14, 2015
    Date of Event
    November 25, 2014
    Report Date
    February 3, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MBH
    PMA / PMN Number
    K141056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER DEVICES WERE ALSO LISTED IN THIS REPORT: ANTIBIOTIC SIMPLEX P BONE CEMENT; CAT# UNKNOWN; LOT# UNKNOWN. TRIATHLON UNIVERSAL TIBIAL BASEPLATE; CAT# UNKNOWN; LOT# UNKNOWN. TRIATHLON TIBIAL AUGMENT HALF BLOCK; CAT# UNKNOWN; LOT# UNKNOWN. TRIATHLON OFFSET ADAPTER; CAT# UNKNOWN; LOT# UNKNOWN. TRIATHLON FLUTED STEM; CAT# UNKNOWN; LOT# UNKNOWN. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. THE INFORMATION IN THIS REPORT WAS PROVIDED BY STRYKER ORTHOPAEDICS LEGAL AFFAIRS DEPARTMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE IS NOT AVAILABLE DUE TO THE ONGOING LITIGATION. SHOULD DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    UPDATED DEVICE INFORMATION REPORTED PREVIOUSLY AS UNKNOWN IN THE INITIAL EMDR ASSOCIATED WITH THIS PI. SIMPLEX P WITH TOBRAMYCIN 1 PACK; CAT# 6197-9-001; LOT# MCV022. TRI TS BASEPLATE SIZE 4; CAT# 5521-B-400; LOT# KTZPD. TRI RM/LL TIB AUG SZ4 10MM; CAT# 5546-A-402; LOT# MC7C08. TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 2MM; CAT# 5570-S-020; LOT# M9L44D. TRI PRESS-FIT STEM 12X150MM; CAT# 5566-S-012; LOT# M9C49J. REPORTED EVENT: AN EVENT REGARDING INFECTION INVOLVING AN X3 TRIATHLON CS INS SIZE 4 16MM WAS REPORTED. THE EVENT WAS CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION WERE NOT PERFORMED AS THE ITEM WAS NOT RETURNED. MEDICAL RECORDS RECEIVED AND EVALUATION: ¿NO X-RAYS AVAILABLE FOR REVIEW. THERE IS NO EXAMINATION OF THE EXPLANTED COMPONENTS, WHICH WERE APPARENTLY INTACT AND REMOVED FOR SUBSIDING INTO THE HOST TIBIA, WHICH WAS LIKELY OSTEOPOROTIC IN THIS OBESE WOMAN WITH MULTIPLE MEDICAL CONDITIONS CONTRIBUTING TO OSTEOPOROSIS. THE PRESENCE OF OSTEOPOROSIS WAS FURTHER SUGGESTED BY THE DEVELOPMENT OF AN INTRAOPERATIVE FEMORAL FRACTURE WHILE PREPARING THE FEMUR AT THE PRIMARY SURGERY. IN RETROSPECT IT WOULD HAVE BEEN PRUDENT TO USE A STEMMED TIBIAL COMPONENT AT THE PRIMARY SURGERY DUE TO THE PATIENT'S OBESITY AND BONE STOCK. AS A RESULT OF REVISION SURGERY SEVENTEEN DAYS POST-OP THE RISK OF INFECTION WAS HEIGHTENED AND, IN FACT, OCCURRED. ATTEMPTS TO ADDRESS THE INFECTION WITH LESS THAN A TWO-STAGE APPROACH RESULTED IN PERSISTENT SEPSIS AND PATELLAR TENDON RUPTURE. THE UNFORTUNATE CLINICAL COURSE OF SUBSIDENCE OF THE PRIMARY TIBIAL COMPONENT AND SUBSEQUENT INFECTION WAS NOT RELATED TO FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING OR MATERIALS OF EITHER THE PRIMARY OR REVISION TOTAL KNEE COMPONENTS.¿ DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATES DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THIS LOT. CONCLUSIONS: THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION. THE CLINICIAN CONCLUDED, ¿THE UNFORTUNATE CLINICAL COURSE OF SUBSIDENCE OF THE PRIMARY TIBIAL COMPONENT AND SUBSEQUENT INFECTION WAS NOT RELATED TO FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING OR MATERIALS OF EITHER THE PRIMARY OR REVISION TOTAL KNEE COMPONENTS.¿ NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR "LEFT KNEE REMOVAL OF INFECTED HARDWARE AND IRRIGATION AND DEBRIDEMENT. HOWEVER, SHE HAD A SERIES OF VENTRICULAR TACHYCARDIA EPISODES ON THE OPERATIVE TABLE AND THE PROCEDURE WAS CANCELLED. SHE DIED ON (B)(6) 2014."

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT WAS RETURNED TO THE OR FOR " LEFT KNEE REMOVAL OF INFECTED HARDWARE AND IRRIGATION AND DEBRIDEMENT. HOWEVER, SHE HAD A SERIES OF VENTRICULAR TACHYCARDIA EPISODES ON THE OPERATIVE TABLE AND THE PROCEDURE WAS CANCELLED. SHE DIED ON (B)(6) 2014."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824914 X3 TRIATHLON CS INS SIZE4 16MM PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO MBH STRYKER ORTHOPAEDICS-MAHWAH LDX564

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death