BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY GMV BONE CEMENT

    MDR report key: 5682150 · Received May 26, 2016

    Report

    Report Number
    1818910-2016-20091
    Event Type
    Injury
    Date Received
    May 26, 2016
    Date of Event
    May 12, 2016
    Report Date
    May 12, 2016
    Manufacturer
    DEPUY CMW 9610921
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    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 MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEVICE HISTORY LOT: A DEVICE HISTORY RECORD (MRE) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. DEPUY SYNTHES HAS BEEN INFORMED THAT THE CATALOG NUMBER AND LOT NUMBER IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT POSSIBLE FOR THE UNKNOWN LOT CODE(S). 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. (B)(4) HAS BEEN UNDERTAKEN TO INVESTIGATE FURTHER. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4) IS USED TO CAPTURE THE SURGICAL INTERVENTION AND MEDICAL DEVICE REMOVAL). 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

    PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. DEPUY CEMENT WAS USED.

    Description of Event or Problem · 1

    MEDICAL RECORD AD 17 JUNE 2019 WAS REVIEWED ON 5 DECEMBER 2019. (B)(6) 2014: THE PATIENT UNDERWENT A TOTAL LEFT KNEE ARTHROPLASTY SECONDARY TO OSTEOARTHRITIS. ATTUNE IMPLANTS WERE USED AS WELL AS DEPUY CEMENT X2. THE PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. (B)(6) 2016: THE PATIENT UNDERWENT REVISION OF THE LEFT KNEE SECONDARY TO PAIN. THE SURGICAL NOTE REVIEWED INDICATES THE COMPONENTS WERE WELL FIXED; HOWEVER, THE TIBIAL BONE WAS NOT WELL FIXED AS IT WAS FIBROUS BETWEEN THE BONE AND CEMENT WHICH WOULD INDICATE LOOSENING AT THE BONE TO CEMENT INTERFACE; ALTHOUGH IT WAS PREVIOUSLY REPORTED AS IMPLANT TO CEMENT INTERFACE. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. PMH: OSTEOARTHRITIS OF THE LEFT KNEE DOI: (B)(6) 2014; DOR: (B)(6) 2016 (LEFT KNEE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337627 UNKNOWN DEPUY GMV BONE CEMENT CEMENT / CEMENT ACCESSORY LOD DEPUY CMW 9610921 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention ATTUNE MEDIAL ANAT PAT 38MM| ATTUNE PS FEM LT SZ 7 CEM| ATTUNE PS RP INSRT SZ 7 8MM