BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT SZ12 LOW COL

    MDR report key: 11552723 · Received March 23, 2021

    Report

    Report Number
    1818910-2021-05787
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    March 5, 2021
    Report Date
    March 5, 2021
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    LZO
    UDI-DI
    10603295478690
    PMA / PMN Number
    K190344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 NUMBER WAS NOT PROVIDED. 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 : 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). WHERE THE LOT CODE WAS PROVIDED, A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PRIMARY SURGERY WAS PERFORMED WITH THE STEM. ON AN UNKNOWN DATE, THE PATIENT FELL, AND THE FRACTURE AROUND THE STEM OCCURRED. ON AN UNKNOWN DATE, THE REVISION SURGERY WAS PERFORMED DUE TO THE FRACTURE AROUND THE STEM. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454837 CORAIL AMT SZ12 LOW COL OTHER PRODUCTS LZO DEPUY FRANCE SAS - 3003895575 L971312 10603295478690

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORAIL AMT SZ12 LOW COL| UNKNOWN HIP FEMORAL HEAD| CORAIL AMT SZ12 LOW COL| UNKNOWN HIP FEMORAL HEAD