BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9260054 · Received October 31, 2019

    Report

    Report Number
    1818910-2019-110621
    Event Type
    Injury
    Date Received
    October 31, 2019
    Date of Event
    January 18, 2017
    Report Date
    October 10, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS 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. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (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, ""MID-TERM RESULTS OF THE BIOLOX DELTA CERAMIC-ON-CERAMIC TOTAL HIP ARTHROPLASTY"" WRITTEN BY Y. K. LEE, Y. C. HA, J-I. YOO, W. L. JO, K-C. KIM, AND K. H. KOO AND PUBLISHED BY THE BONE AND JOINT JOURNAL VOL. 99-B, NO. 6, JUNE 2017 ACCEPTED BY PUBLISHER 18 JANUARY 2017 WAS REVIEWED. THE ARTICLE'S PURPOSE WAS TO REPORT ON A STUDY OF A DELTA CERAMIC THAS TO DETERMINE THE RATE OF CERAMIC FRACTURE, TO CHARACTERIZE POST-OPERATIVE NOISE, AND TO EVALUATE THE MID-TERM RESULTS AND SURVIVORSHIP. THE DATA WAS COMPILED FROM 252 PATIENTS (286 HIPS) WITH A FOLLOW DURATION MEAN OF 66.5 MONTHS AND AVERAGE AGE OF 49.7 YEARS (144 MEN AND 108 WOMEN). DEPUY PRODUCTS UTILIZED: PINNACLE CUP, CORAIL STEM, AND COC BEARINGS ON ALL HIPS. THE ARTICLE CAPTURES GENERALIZED ADVERSE EVENTS, 2 NARRATIVE DESCRIPTIONS WITH PATIENT IDENTIFIERS AND ADDITIONALLY A TABLE DISPLAYING 32 PATIENTS WHO EXPERIENCED IMPLANT NOISE ALL CAPTURED IN LINKED COMPLAINTS. THIS COMPLAINT CAPTURES A (B)(6) OLD MAN WITH PERIPROSTHETIC INFECTION TREATED WITH ARTICULATING CEMENT SPACER AND ANTIBIOTICS THEN RECEIVED NEW IMPLANTS FOUR MONTHS POST FIRST STAGE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1054507 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD KWY DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention