BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 8952685 · Received August 30, 2019

    Report

    Report Number
    1818910-2019-102797
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    December 22, 2015
    Report Date
    August 13, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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). NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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). 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. INVESTIGATION METHODS: WAS PATIENT AFFECTED: YES. DEVICE HISTORY REVIEWED: NO. LOT TRACE OBTAINED: NO. COMPLAINTS DATABASE SEARCHED: NO. PRODUCT CHECKED: NO. LABEL CHECKED: NO. PRODUCT PULLED FROM STOCK FOR INSPECTION: NO. A REVIEW OF COMPLAINT DATABASES WAS NOT POSSIBLE AS NO PRODUCT DETAILS WERE AVAILABLE. IT SHOULD BE NOTED THAT NO DEVICE WAS RETURNED. WITHOUT THE PHYSICAL COMPLAINT SAMPLE(S) ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE(S) FAILED TO MEET SPECIFICATION(S) AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. THE DEVICE(S) ASSOCIATED WITH THIS EVENT WERE USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. NO INFORMATION RECEIVED WITH THIS INDIVIDUAL COMPLAINT INDICATED THAT A BROADER INVESTIGATION OR CORRECTIVE ACTION WAS NECESSARY. 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. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; ENTERED INTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. POST MARKET SURVEILLANCE IS PER (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITERATURE ARTICLE ENTITLED "INCREASED RISK FOR EXTENDED ACETABULAR RECONSTRUCTION IN FAILED HIP RESURFACING AS COMPARED TO FAILED TOTAL HIP ARTHROPLASTY" BY O. JAKOBS, S. SCHMIDL, B. SCHOOF, J. BECKMANN, T. GEHRKE, M. GEBAUER PUBLISHED ONLINE B YARCH ORTHOP TRAUMA SURG (2016) 136:413¿424 DOI 10.1007/S00402-015-2364-X ON 22 DECEMBER 2015 WAS REVIEWED FOR MDR REPORTABILITY. PURPOSE OF THE STUDY: THIS RETROSPECTIVE STUDY WAS PERFORMED TO ELUCIDATE THE NEED FOR ACETABULAR RECONSTRUCTION IN THE REVISION OF FAILED HR ARTHROPLASTIES. WE ANALYZED DATA FROM A SET OF CONSECUTIVE PATIENTS WHO UNDERWENT CONVERSION OF A HR INTO A THA IN OUR UNIT. THE MAIN GOALS OF THE STUDY WERE TO CHARACTERIZE WHETHER (1) THERE IS AN INCREASED NEED TO RECONSTRUCT EXTENDED BONE DEFECTS DURING HR REVISION PROCEDURES AND WHETHER (2) SURGICAL REVISION OF FAILED HR IS EQUIVALENT TO THE REVISION OF FAILED PRIMARY THA IN TERMS OF THE TECHNIQUES REQUIRED." THE ARTICLE REPORTS ON 39 REVISIONED IMPLANTS FOR 38 PATIENTS WITH ASR (16) AND 23 OTHER NON-DEPUY PRODUCTS. ALTHOUGH THE ARTICLE LISTS EACH PATIENT BY CASE NUMBER IT DOES NOT ASSOCIATE WHICH PRODUCTS BELONG TO EACH PATIENT. SUMMARIZED ADVERSE EVENTS NOTED: PAIN, METALLOSIS WITH METAL DEBRIS CONFIRMED BY REVISION, PSEUDOTUMORS, PRESENCE OF OSTEOLYSIS, LOOSE FEMORAL COMPONENTS, LOOSE ACETABULAR COMPONENTS, ELEVATED ION LEVELS, INFECTION, DISLOCATION, DECREASED HIP ROM DUE TO IMPINGEMENT, SYNOVITIS, CREPITATING NOISES. IMPACTED PRODUCTS: ASR RESURFACING IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746428 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention