BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPS UNIV TIB HIN INS XSM 12MM

    MDR report key: 9908097 · Received March 31, 2020

    Report

    Report Number
    1818910-2020-09815
    Event Type
    Injury
    Date Received
    March 31, 2020
    Date of Event
    February 7, 2020
    Report Date
    February 9, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KRO
    UDI-DI
    10603295079392
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION 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. PRODUCT COMPLAINT # (B)(4) INVESTIGATION SUMMARY - UPDATE 11-JUNE-2020: THE INVESTIGATION WAS RE-OPENED UPON RECEIPT OF THE PRODUCT. EXAMINATION OF THE RETURNED DEVICE COULD NOT CONFIRM THE REPORTED EVENT. THE DEVICE WAS MANUFACTURED ON 12/13/2016. 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 NUMBER: H20956. PRODUCT CODE: 198727112. BFARM REQUEST, PLEASE PROVIDE 1) QUANTITY MANUFACTURED ¿ (B)(4). 2) DATE OF MANUFACTURE- (B)(6) 2016. 3) ANY ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR- NA 4) EXPIRY DATE - 11/30/2021. 5) IFU REFERENCE-090200773 REV J." 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 COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. 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. 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.

    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.

    Description of Event or Problem · 1

    REVISION OF UNKNOWN PARTS OF A LPS KNEE SYSTEM BECAUSE OF INLAY FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365721 LPS UNIV TIB HIN INS XSM 12MM LPS AND S-ROM : KNEE TIBIAL INSERT KRO DEPUY ORTHOPAEDICS INC US 1987-27-112 H20956 10603295079392

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention LPS CEMENTED STEM 16X125MM STR| LPS DISTAL FEM COMP XSM RT| MBT REVISION CEM TIB TRAY SZ| MBT TRAY SLEEVE POR M/L 61MM| UNIVERSAL STEM 115X16MM FLUTED