BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL AUGMENT

    MDR report key: 9248276 · Received October 28, 2019

    Report

    Report Number
    1818910-2019-110300
    Event Type
    Injury
    Date Received
    October 28, 2019
    Date of Event
    August 5, 2012
    Report Date
    October 4, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION: PATIENT CODE ((B)(4)) USED TO CAPTURE MEDICAL DEVICE REMOVAL.

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION DEPUY SYNTHES OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON 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. 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, "CEMENTLESS MODULAR TOTAL HIP ARTHROPLASTY IN PATIENTS YOUNGER THAN FIFTY WITH FEMORAL HEAD OSTEONECROSIS: MINIMUM FIFTEEN-YEAR FOLLOW-UP" WRITTEN BY SANG-MIN KIM MD, SEUNG-JAE LIM MD, YOUNG-WAN MOON MD, YANG-TAE KIM MD, KYUNG-RAE KO MD, AND YOUN-SOO PARK MD PUBLISHED BY THE JOURNAL OF ARTHROPLASTY 28 (2013) 504¿509 ACCEPTED BY PUBLISHER 5 AUGUST 2012 WAS REVIEWED. THE ARTICLE'S PURPOSE: "THE PURPOSE OF THIS STUDY WAS TO REPORT THE CLINICAL AND RADIOGRAPHIC RESULTS OF CEMENTLESS PRIMARY THA USING A MODULAR STEM IN A SERIES OF PATIENTS YOUNGER THAN FIFTY YEARS WITH OSTEONECROSIS OF THE FEMORAL HEAD WHO WERE FOLLOWED FOR A MINIMUM OF FIFTEEN YEARS." THE DATA WAS COMPILED FROM 64 HIPS (55 PATIENTS - 40 MALE AND 15 FEMALE WITH AVERAGE AGE OF 40.2 YEARS) WITH AVERAGE FOLLOW UP 15.8 YEARS RECEIVED IMPLANTS FROM DECEMBER 1994 TO SEPTEMBER 1996. DEPUY PRODUCTS WERE UTILIZED: SROM FEMORAL STEM, CEMENTLESS ARTHROPORE I OR II CUP WITH POLY LINER IN 60 HIPS AND THE REMAINING 4 HIPS WERE NON-DEPUY CUPS. BEARING SURFACES WERE COP (45 HIPS) AND MOP (19 HIPS). THE ARTICLE REPORTS UPON GENERALIZED RESULTS BUT ALSO IDENTIFIES 4 INDIVIDUAL PATIENTS WITH ADVERSE EVENTS THAT ARE CAPTURE ON LINKED COMPLAINTS. THE ARTICLE DOES NOT SPECIFY IF PATIENTS RECEIVED INTERVENTIONS BASED UPON RADIOGRAPHIC DETECTIONS. THE ARTICLE REPORTS "NO HIPS SHOWED FEMORAL OSTEOLYSIS WITHOUT GROSS RADIOGRAPHIC EVIDENCE OF POLYETHYLENE WEAR AND RADIOGRAPHIC EVIDENCE OF METALLIC DEBRIS. LOOSENING OF FEMORAL COMPONENTS WAS NOT SEEN IN ANY OF THE CASES IN THIS SERIES. THIS COMPLAINT CAPTURES A (B)(6) YEAR OLD MAN WHO EXPERIENCED A FEMORAL FRACTURE 2 YEARS AFTER SURGERY AND RECEIVED REVISION WITH A LONGER STEM WITH POSITIVE OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039250 UNKNOWN HIP FEMORAL AUGMENT HIP FEMORAL AUGMENT JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention