BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG CONSTRAINED INSERT 28G

    MDR report key: 2142418 · Received June 21, 2011

    Report

    Report Number
    2249697-2011-00927
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWZ
    PMA / PMN Number
    K061654
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: C-TAPER COCR LFIT HEAD 28MM/-3, CAT# 06-2898, LOT# MJNL13; TRIDENT PSL HA CLUSTER 58MM, CAT# 542-11-58G, LOT# N34M; ACETABULAR DOME HOLE PLUG, CAT# 2060-0000-1, LOT# MJPYDR; 6.5 CANCELLOUS BONE SCREW 35MM, CAT# 2030-6535-1, LOT# MJT5PK, MJTER2 AND MJT3HV; 6.5 CANCELLOUS BONE SCREW 30MM, CAT# 2030-6530-1, LOT# MJRE50; 6.5 CANCELLOUS BONE SCREW 20MM, CAT# 2030-6520-1, LOT# MJRP2T. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED PRODUCT LUXATION. AN EVAL OF THE DEVICE(S) CANNOT BE PERFORMED AS THE DEVICE(S) WAS NOT RETURNED TO THE MFR. ADD'L INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED VIA SALES REP THAT: SURGERY (B)(6) 2011 (APPROX.): THE REF (B)(4) WERE EXPLANTED AND REPLACED (SEE (B)(4); MFR # 2249697-2011-00926). PT WAS NOT DISCHARGED FROM HOSPITAL (B)(6). THERE WAS A PRODUCT LUXATION. SURGERY (B)(6) 2011: ALL IMPLANTS WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIDENT 0 DEG CONSTRAINED INSERT 28G IMPLANT KWZ STRYKER ORTHOPAEDICS MAHWAH NA MJT3RR

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention