BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK HIP FEMORAL STEM CORAIL

    MDR report key: 15053462 · Received July 19, 2022

    Report

    Report Number
    1818910-2022-13409
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    November 3, 2021
    Report Date
    July 19, 2022
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THIS COMPLAINT WAS OPENED TO DOCUMENT COMPLAINTS DERIVED THROUGH A JOURNAL ARTICLE REVIEW. FOLLOW-UPS WERE DONE TO TRY AND OBTAIN ADDITIONAL INFORMATION FROM THE AUTHOR OF THE JOURNAL ARTICLE. NO FURTHER INFORMATION WAS RECEIVED. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION (MRE) WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    "THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GREWAL US, BAWALE R, SINGH B, SANDIFORD A, SAMSANI S. OUTCOMES FOLLOWING NON-OPERATIVELY MANAGED PERIPROSTHETIC FRACTURES SURROUNDING UNCEMENTED FEMORAL STEMS. J CLIN ORTHOP TRAUMA. 2021 NOV 3;24:101688. DOI: 10.1016/J.JCOT.2021.101688. PMID: 34853774; PMCID: PMC8607200. OBJECTIVE AND METHODS: THE PRIMARY AIM OF THIS STUDY WAS TO EXPLORE THE OUTCOMES OF VANCOUVER B PERIPROSTHETIC HIP FRACTURES THAT WERE MANAGED NON-OPERATIVELY WITH A PARTICULAR FOCUS ON 1-YEAR MORTALITY IN 18 PATIENTS IMPLANTED BETWEEN APRIL 2009 AND APRIL 2019. THE DATA WAS COLLECTED FROM THE FRACTURE DATABASE AND VARIOUS STEM MANUFACTURERS WERE UTILIZED. TREATMENT FOR THE FRACTURES WAS TOE TOUCH AND RESTRICTED WEIGHT BEARING. NO STEMS WERE REVISED, AND NO INVASIVE TREATMENT WAS PROVIDED. THIS COMPLAINT WILL CAPTURE THE FRACTURES ASSOCIATED WITH DEPUY STEMS. CASE 5: B1 VANCOUVER PPF AROUND A COLLARED CORAIL STEM. CASE 8: B1 VANCOUVER PPF AROUND A NON-COLLARED CORAIL STEM. CASE 9: B1 VANCOUVER PPF AROUND A COLLARED CORAIL STEM. CASE 12: B1 VANCOUVER PPF AROUND A NON-COLLARED CORAIL STEM. CASE 13: B1 VANCOUVER PPF AROUND A NON-COLLARED CORAIL STEM. CASE 15: B2 VANCOUVER PPF AROUND A COLLARED CORAIL STEM WITH >5MM STEM SUBSIDENCE. CASE 16: B1 VANCOUVER PPF AROUND A NON-COLLARED CORAIL STEM. CASE 18: B1 VANCOUVER PPF AROUND A HEMI CORAIL STEM. RADIOGRAPHIC IMAGES ARE NOT IDENTIFIED BY DEVICE MANUFACTURER: IMAGE 1 & 2 ON PP. 3; IMAGE 3 & 4 PP. 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251550 UNK HIP FEMORAL STEM CORAIL FEMORAL STEM LZO DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown