BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIAL ROTATION KNEE® LEFT TIBIAL INSERT SIZE 2, 10.5MM

    MDR report key: 17153207 · Received June 19, 2023

    Report

    Report Number
    1818910-2023-12447
    Event Type
    Malfunction
    Date Received
    June 19, 2023
    Date of Event
    May 30, 2023
    Report Date
    June 19, 2023
    Manufacturer
    FINSBURY ORTHOPAEDICS LIMITED
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. 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. 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 : THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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

    PRIMARY BILATERAL SURGERY WAS PERFORMED BY [SURGEON] AT THE HOSPITAL ON (B)(6) 2009 AND FOLLOWING IMPLANTS WERE IMPLANTED: LEFT KNEE: 158-013 (LOT#: 67063, EXP: 12-2011), 158-352 (LOT#: 81123, EXP: 02-2013), 156-522 (LOT#: 51893, EXP: 06-2010). RIGHT KNEE: 158-023 (LOT#: 67101, EXP: 12-2011), 158-352 (LOT#: 67427, EXP: 02-2012), 156-623 (LOT#: 66220, EXP: 08-2011). LEFT KNEE WAS REVISED ON (B)(6) 2023. POLY (156-522) WAS EXPLANTED, NEW POLY (156-523, LOT #: 239109 EXP: 09-2032) WAS IMPLANTED ALONG WITH SAIPH PATELLA (190-114, LOT #: 227152, EXP: 05-2029) BY SAME SURGEON AT THE SAME FACILITY. IF THIS IS A REVISION PROCEDURE, PLEASE PROVIDE A DESCRIPTION OF THE EXPLANTED DEVICES (GOOD CONDITION, UNEXPECTED WEAR ETC.) WEAR ON THE BEARING SURFACE ¿ POOR CONDITION. WE HAVE ASKED FOR THE EXPLANT TO BE RETURNED FOR FORWARDING TO THE UK FOR ANALYSIS EVENT DATE: (B)(6) 2023. PATIENT WAS EXPERIENCING PERFUSION OF THEIR LEFT KNEE PAIN, INSTABILITY & NEED TO REVIEW WITH SURGEON 14 YEARS AFTER IT WAS IMPLANTED. BLOOD TEST REVEALED NO KNOWN ISSUE PRIOR TO THE REVISION CASE. IN THE CASE SAMPLES WERE TAKEN FROM WITHIN THE JOINT. MAIN FOCUS WAS AN ENLARGED AND MISSHAPED SYNOVITIS THAT WAS REMOVED. THE 10.5MM WAS EXCHANGED FOR A 13MM POLY. WHILST IN THIS REVISION THE LEFT PATELLA WAS RESURFACED. THE PATELLA USED FOR THIS CASE WAS A SAIPH 38MM (190-114, LOT#: 227152).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814894 MEDIAL ROTATION KNEE® LEFT TIBIAL INSERT SIZE 2, 10.5MM MRK KNEE SYSTEM : KNEE TIBIAL INSERT JWH FINSBURY ORTHOPAEDICS LIMITED 51893

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female MEDIAL ROTATION KNEE LEFT TIBIAL INSERT 2, 10.5MM| MRK FEMUR PEGGED CPTI + HAP (DUAL COAT) LEFT F3| MRK TIBIA METAL BACK T2 50MMSTEM CPTI & HAP