BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*SIGMA/OV/DOME PAT 3PEG,41

    MDR report key: 9953640 · Received April 13, 2020

    Report

    Report Number
    1818910-2020-10636
    Event Type
    Injury
    Date Received
    April 13, 2020
    Date of Event
    March 4, 2020
    Report Date
    March 27, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    UDI-DI
    10603295232636
    PMA / PMN Number
    K961685
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER RELATED REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT CODE/LOT NUMBER COMBINATION 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. 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 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

    (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR ADHESIONS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE). TREATMENT: MANIPULATION UNDER ANESTHESIA ON (B)(6) 2020. DEPUY COMPONENTS: CATALOG ID: 960103. LOT: 9332409. DESCRIPTION: SIGMA PATELLA OVAL DOME 3 PEGGED 41MM. CATALOG ID: 196192042. LOT: 9356854. DESCRIPTION: AOX CVD RP TIBIAL INSERT SZ 4 12.5MM. CATALOG ID: 129433140. LOT: 9227779. DESCRIPTION: MBT CEMENTED KEEL SZ 4. CATALOG ID: 960004. LOT: D19041827. DESCRIPTION: SIGMA FEM C/RET CEMENTED LT SZ 4. CATALOG ID: 3312040. LOT: 9167582. DESCRIPTION: SMART SET CMW 1 40G. CATALOG ID: 3312040. LOT: 9102840. DESCRIPTION: SMART SET CMW 1 40G.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416309 PFC*SIGMA/OV/DOME PAT 3PEG,41 SIGMA KNEE PRIMARY : KNEE PATELLA JWH DEPUY ORTHOPAEDICS INC US 96-0103 9332409 10603295232636

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention DEPUY CMW 1 40G| DEPUY CMW 1 40G| MBT CEM KEEL TIB TRAY SZ4| PFC*SIGMA C/R NPOR FEM LT SZ 4| PFC*SIGMA/OV/DOME PAT 3PEG,41| SIG RP AOX CRV INS SZ4 12.5