BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP ACETABULAR CUP ASR

    MDR report key: 17198056 · Received June 26, 2023

    Report

    Report Number
    1818910-2023-12920
    Event Type
    Injury
    Date Received
    June 26, 2023
    Date of Event
    June 6, 2018
    Report Date
    June 26, 2023
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : DEVICE HISTORY REVIEWS FOR ASR PLATFORM HAVE SHOWN NO INDICATION OF DEVIATIONS OR ANOMALIES WITH REGARD TO MATERIAL, MANUFACTURING OR INSPECTION.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THE SIZE OF THE ARTICLE IS TOO LARGE TO ATTACH/SUBMIT WITH THE 3500A SUBMISSION. THE CITATION OF THE ARTICLE HAS BEEN PROVIDED BELOW: HERNÁNDEZ-VAQUERO D, GARCÍA-PASCUAL M, IGLESIAS-FERNÁNDEZ S, ESCANDON-RODRÍGUEZ A. METAL-ON-METAL SURFACE HIP ARTHROPLASTIES. IS ANNUAL MONITORING OF BLOOD METAL LEVELS NECESSARY? REV ESP CIR ORTOP TRAUMATOL (ENGL ED). 2018 NOV-DEC;62(6):436-441. ENGLISH, SPANISH. DOI: 10.1016/J.RECOT.2018.03.001. EPUB 2018 JUN 6. PMID: 29884514. D4-THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT WAS SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. 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. 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 · 0

    ARTICLE ENTITLED "METAL-ON-METAL SURFACE HIP ARTHROPLASTIES. IS ANNUAL MONITORING OF BLOOD METAL LEVELS NECESSARY?" WRITTEN BY HERNÁNDEZ-VAQUERO D, GARCÍA-PASCUAL M, IGLESIAS-FERNÁNDEZ S, AND ESCANDON-RODRÍGUEZ A. PUBLISHED ON JUNE 6, 2018 WAS REVIEWED. THE AIM OF OUR STUDY WAS TO PRESENT SERIAL 7-13 YEAR BLOOD CO AND CR LEVELS IN A COHORT OF MOM TOTAL HIP ARTHROPLASTIES IN ASYMPTOMATIC PATIENTS. 52 HIPS WERE IMPLANTED WITH ASR HEMI IMPLANTS. ADVERSE EVENTS: 8 REVISIONS DUE TO ELEVATED METAL ION LEVELS. 2 REVISIONS DUE TO ALVAL. 2 REVISIONS DUE TO FEMORAL NECK BONE FRACTURE. 1 REVISION DUE TO OSTEOLYSIS. 1 REVISION DUE TO INSTABILITY WITH REPEATED LUXATIONS. 2 REVISIONS DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804513 UNK HIP ACETABULAR CUP ASR HIP ACETABULAR CUP KWA DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention