BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 8961182 · Received September 4, 2019

    Report

    Report Number
    1818910-2019-102694
    Event Type
    Injury
    Date Received
    September 4, 2019
    Report Date
    August 15, 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 Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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. UPDATED INFO IN H7, H8, H9, AND H10.

    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). 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 CODE(S) 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. CORRECTIVE ACTION WAS NOT INDICATED. 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

    (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 ASSESSMENT OF PATIENTS WITH A DEPUY ASR METAL-ON-METAL HIP REPLACEMENT: RESULTS OF APPLYING THE GUIDELINES OF THE SPANISH SOCIETY OF HIP SURGERY IN A TERTIARY REFERRAL HOSPITAL BY JENARO FERNÁNDEZ-VALENCIA, XAVIER GALLART, GUILLEM BORI, SEBASTIÁN GARCIA RAMIRO, ANDRÉS COMBALÍA, AND JOSEP RIBA PUBLISHED BY HINDAWI PUBLISHING CORPORATION. ADVANCES IN ORTHOPEDICS VOLUME 2014, ARTICLE ID 982523, 4 PAGES; HTTP://DX.DOI.ORG/10.1155/2014/982523 ON 9 NOVEMBER 2014 WAS REVIEWED FOR REPORTABILITY. THE PURPOSE: " THIS PAPER REPORTS THE RESULTS OBTAINED IN A SERIES OF PATIENTS WHO WERE EVALUATED WITH THIS ALGORITHM AS A RESPONSE TO THE RECALL." THE ARTICLE REPORTS LETTERS WERE SENT TO 83 PATIENTS WITH 92 CUPS AND A MEAN AGE OF 51 YEARS FOR PARTICIPATION AND AWARENESS. "FIVE PATIENTS DID NOT RESPOND TO THE LETTER, AND THREE HAD DIED FOR REASONS UNRELATED TO THE HIP SURGERY. THIS LEFT A TOTAL OF 83 DEPUY ASR CUPS, 60 OF WHICH CORRESPONDED TO RESURFACING AND 23 TO THE USE OF THE SHORT-STEM PROXIMA IMPLANT. MEAN TIME AT FOLLOW-UP WAS 2.9 YEARS (RANGE 0.9¿5.5, SD 1.05). IN THE ORIGINAL INDICATIONS FOR SURGERY, PATIENTS WITH CHRONIC RENAL INSUFFICIENCY, WOMEN OF A FERTILE AGE, AND PATIENTS WITH A KNOWN ALLERGY TO METALS WERE ALL EXCLUDED." THE ARTICLE REPORTS THERE WERE NO CASE OF LOOSENING OR OSTEOLYSIS. "EIGHT RESURFACING IMPLANTS REQUIRED REVISION DUE TO THE PRESENCE OF PAIN AND/OR ELEVATED SERUM LEVELS OF CHROMIUM/COBALT." "THE INTRAOPERATIVE FINDINGS WERE OF NO RELEVANCE IN SIX CASES; IN ONE CASE A SOLID PSEUDOTUMOUR WAS IDENTIFIED, WHILE ANOTHER PATIENT PRESENTED WITH METALLOSIS AND A FLUID-FILLED PSEUDOTUMOUR (FIGURE 1). THE HISTOLOGY OF THE CASE OF THE PSEUDOTUMOUR SHOWED LYMPHOPLASMA CELLULAR INFILTRATION AND PRESENCE OF MACROPHAGES AND MULTINUCLEATED GIANT CELLS DEPICTING A FOREIGN BODY REACTION." "ADDED TO THESE EIGHT REVISIONS AFTER THE RECALL, TWO PREVIOUS ASR IMPLANTS WERE EXCHANGED PREVIOUSLY TO THE RECALL: AS A RESULT, THE REVISION RATE FOR ASR CUPS IN OUR CENTRE IS 18.2% AT 2.9 YEARS." ALSO NOTED THAT CUP ABDUCTION ANGLES WERE 15-52 INDICATING MALPOSITIONED CUPS. SERUM COBALT LEVELS RANGES 5-56 MCG/L AND CHROMIUM 2.1-40 MCG/L. IMPACTED PRODUCTS: ASR RESURFACING IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754540 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD KWA DEPUY INTERNATIONAL LTD. 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R