BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CUP

    MDR report key: 9005857 · Received September 12, 2019

    Report

    Report Number
    1818910-2019-103904
    Event Type
    Injury
    Date Received
    September 12, 2019
    Date of Event
    March 10, 2014
    Report Date
    August 21, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. 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 WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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

    DIRECT ANTERIOR TOTAL HIP ARTHROPLASTY YIELDS MORE RAPID VOLUNTARY CESSATION OF ALL WALKING AIDS: A PROSPECTIVE, RANDOMIZED CLINICAL TRIAL BY MICHAEL J. TAUNTON, MD, J. BOHANNON MASON, MD, SUSAN M. ODUM, PHD, AND BRYAN D. SPRINGER, MD PUBLISHED BY THE JOURNAL OF ARTHROPLASTY 29 SUPPL. 2 (2014) 169-172 HTTP://DX.DOI.ORG/10.1016/J.ARTH.2014.03.051 ON 10 MARCH 2014. ARTICLE PURPOSE: "OUR PURPOSE WILL BE TO DETERMINE IF DIFFERENCES EXIST IN THE ATTAINMENT OF FUNCTIONAL MILESTONES THAT REFLECT ACTIVITIES OF DAILY LIVING BETWEEN MPA-THA AND DA-THA. THE PRIMARY ENDPOINT IS THE DIFFERENCE BETWEEN GROUPS IN THE POSTOPERATIVE TIME THAT PATIENTS REQUIRE ANY ASSISTIVE DEVICES FOR AMBULATION. WE ALSO HOPE TO DETERMINE IF THE GENERAL HEALTH OUTCOME AFTER DA THA WAS BETTER THAN THAT AFTER MPA-THA AS MEASURED WITH SHORT FORM-12 (SF-12) SCORES, AND TO EVALUATE VARIATION OF SURGICAL FACTORS OF THE TWO PROCEDURES ON THE BASIS OF THE OPERATIVE TIME, COMPONENT POSITIONING, AND OCCURRENCE OF EARLY COMPLICATIONS." IT IS NOTED ALL PATIENTS WERE IMPLANTED WITH CORAIL FEMORAL COMPONENTS WITH PINNACLE ACETABULAR COMPONENTS. THE RESULTS: PATIENTS RECOVERED FASTER AFTER DIRECT ANTERIOR TOTAL HIP ARTHROPLASTY THAN MINI-POSTERIOR APPROACH TOTAL HIP ARTHROPLASTY AS MEASURED BY THE PRIMARY OUTCOME VARIABLE, TIME TO AMBULATION WITHOUT ANY ASSISTIVE DEVICE. IMPACTED PRODUCTS: CORAIL STEM, PINNACLE CUP/LINER, UNKNOWN HEAD. ADVERSE EVENTS: INTRAOPERATIVE CRACK OF THE CALCAR (3 - 1 IN POSTERIOR APPROACH GROUP AND 2 IN THE DA-THA GROUP) ALL TREATED WITH INTRAOPERATIVE CERCLAGE WIRING, WOUND COMPLICATION THAT REQUIRED IRRIGATION AND DEEBRIDEMENT IN THE MPA-THA GROUP (1) WHICH THEN HEALED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801474 UNKNOWN HIP ACETABULAR CUP HIP ACETABULAR CUP KWY DEPUY ORTHOPAEDICS INC US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention