BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL AUGMENT

    MDR report key: 9315601 · Received November 13, 2019

    Report

    Report Number
    1818910-2019-112701
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    April 28, 2014
    Report Date
    October 17, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: PRODUCT COMPLAINT(B)(4). INVESTIGATION SUMMARY :NO DEVICE WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "A NEW TECHNIQUE OF SUBTROCHANTERIC SHORTENING IN TOTAL HIP ARTHROPLASTY" WRITTEN BY SIMON PEARCE, AMIR-REZA JENABZADEH, WILLIAM L WALTER, AND RONALD MARK GILLIES PUBLISHED BY BMJ CASE REP. 2014 MAY 20;2014. PII: BCR2013202813. DOI: 10.1136/BCR-2013-202813 ACCEPTED BY PUBLISHER 28 APRIL 2014 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO PRESENT TWO CASES OF PATIENTS WITH SROM MODULAR HIP SYSTEM THAT EXPERIENCED FRACTURE OF THE FEMORAL PROSTHESIS. EACH CASE IS CAPTURED INDIVIDUALLY IN LINKED COMPLAINTS. THIS COMPLAINT CAPTURES CASE 2 OF A (B)(6) WOMAN WHO HAD A ONSET OF LEFT SIDED THIGH AND KNEE PAIN WHEN BEARING WEIGHT WITHOUT ANY EPISODES OF TRAUMA 4 YEARS POST IMPLANTATION. IT WAS DISCOVERED THAT A PROSTHESIS FRACTURE OCCURRED ON THE POSTERIOR TINE OF THE SLOTTED SECTION OF THE STEM. SHE WAS MANAGED CONSERVATIVELY WITH ANALGESICS AND PROTECTIVE WEIGHT BEARING WITH PAIN RESOLVING AND DISAPPEARING WITHIN 8 WEEKS OF ONSET. ALSO NOTED THAT THE SROM STEM WAS PREVIOUSLY REVISED FOR INFECTION WHERE THE SROM STEM AND BEARING SURFACES WERE REPLACED FOLLOWED BY A NEW SROM PROSTHESIS (THE DEVICE THAT EXPERIENCED A PROSTHESIS FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1110138 UNKNOWN HIP FEMORAL AUGMENT HIP FEMORAL AUGMENT KXA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention