BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADEPT METAL ON METAL CUP 48MM WITH 42MM BORE

    MDR report key: 9676626 · Received February 6, 2020

    Report

    Report Number
    1818910-2020-04118
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    September 14, 2015
    Report Date
    December 10, 2019
    Manufacturer
    FINSBURY ORTHOPAEDICS LIMITED
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 CODE(S) WAS NOT PROVIDED. 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. UPDATED 02 NOVEMBER 2020 RE-OPEN. THE COMPLAINT WAS RE-OPENED UPON RECEIVING FURTHER CORRESPONDENCE. THE INFORMATION RECEIVED DID NOT CHANGE THE ORIGINAL INVESTIGATION REPORT. UPDATED 04 NOVEMBER 2020 RE-OPEN. THE COMPLAINT WAS RE-OPENED UPON RECEIVING THE PRODUCT DETAILS. A REVIEW OF THE CUP PRODUCT, CODE 172485, LOT 81153 MANUFACTURING RECORDS WAS COMPLETED BY THE MANUFACTURING SITE, WITH NOTIFICATION RECEIVED THAT: PRODUCT CODE 172485, WORK ORDER 81153 WAS MANUFACTURED ON THE 10 DECEMBER 2007. 20 PARTS WERE STARTED AND 1 WAS SCRAP, LEAVING 19 MANUFACTURED PER SPECIFICATION AND ALL RAW MATERIAL MET SPECIFICATION. EXPIRY DATE: NOVEMBER 2012. IFU NUMBER: PI-400-442. THERE WAS 1 PART SCRAPPED WITH WORK ORDER 81153. THERE WERE NO DEVIATIONS FOUND TO BE ASSOCIATED WITH WORK ORDER 81153. H10 ADDITIONAL NARRATIVE: ADDED: D4 (LOT #).

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H6 PATIENT CODE: NO CODE AVAILABLE (3191) USED TO CAPTURE THE DEVICE REVISION OR REPLACEMENT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    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 CODE(S) WAS NOT PROVIDED. 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. INITIAL REPORTER OCCUPATION: LAWYER.

    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: CORRECTED:H6(DEVICE CODES). 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 CODE(S) WAS NOT PROVIDED. 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. 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

    APPENDIX C ALLEGES METAL WEAR. THIS CLAIM IS NOW LITIGATED. DOI: (B)(6) 2008 - DOR: (B)(6) 2015 (RIGHT HIP).

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. 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

    ADEPT CLAIM LETTER RECORD RECEIVED. AWAITING FOR ENGLISH TRANSLATION. ONCE AVAILABLE THIS COMPLAINT WILL BE UPDATED ACCORDINGLY. DOI: (B)(6) 2008; DOR: (B)(6) 2015; RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139278 ADEPT METAL ON METAL CUP 48MM WITH 42MM BORE ADEPT IMPLANT : HIP METAL ACETABULAR CUPS KWA FINSBURY ORTHOPAEDICS LIMITED 81153

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ADEPT® METAL ON METAL RESURFACING HEAD 42MM