BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM C-STEM

    MDR report key: 15102460 · Received July 26, 2022

    Report

    Report Number
    1818910-2022-13992
    Event Type
    Injury
    Date Received
    July 26, 2022
    Date of Event
    November 21, 2021
    Report Date
    July 26, 2022
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    Adverse Event
    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. CORRECTED: G1.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TOWNSEND O, JAIN S, LAMB JN, SCOTT CEH, DUNLOP DG, PANDIT HG. PERIPROSTHETIC FEMORAL FRACTURE TYPE AND LOCATION ARE INFLUENCED BY THE PRESENCE OF AN IPSILATERAL KNEE ARTHROPLASTY IMPLANT: A CASE-CONTROL STUDY OF 84 INTERPROSTHETIC FEMORAL FRACTURES. INJURY. 2022 FEB;53(2):645-652. DOI: 10.1016/J.INJURY.2021.11.047. EPUB 2021 NOV 23. PMID: 34893307. OBJECTIVE AND METHODS: AUTHORS PERFORMED MULTICENTER CASE-CONTROLLED STUDY COMPARING CASES OF INTER-PROSTHETIC FEMORAL FRACTURE (IPFF) BETWEEN PRIMARY TOTAL HIP ARTHROPLASTY (THA) AND IPSILATERAL TOTAL KNEE ARTHROPLASTY (TKA) TO CASES OF PERIPROSTHETIC FEMORAL FRACTURE (PFF) WITHOUT IPSILATERAL TKA. EIGHTY-FOUR IPFFS WERE ASSESSED FOR FRACTURE CLASSIFICATION TYPE. EACH IPFF CASE (84 TOTAL) WAS MATCHED TO FIVE PFF CONTROLS (360 TOTAL) BY AGE, GENDER, AND STEM FIXATION. FRACTURE TYPES WERE COMPARED BETWEEN THE IPFF AND PFF GROUPS. THE CASE DETAILS AND PRODUCT MANUFACTURERS WERE NOT PROVIDED FOR THE CONTROL GROUP. WITHIN THE IPFF STUDY GROUP OF 84, DEPUY PRODUCTS ACCOUNTED FOR 37 OF THE TOTAL FEMORAL STEMS UTILIZED. STUDY DID NOT BREAK OUT INDIVIDUAL CASES BY PATIENT CASE NUMBER OR AGE/GENDER DEMOGRAPHICS. NO ADDITIONAL PRODUCT INFORMATION WAS PROVIDED, WITH RESPECT TO THE MANUFACTURER OF ACETABULAR COMPONENTS, NOR WITH REGARD TO THE MANUFACTURERS/PRODUCT DETAILS OF THE ASSOCIATED TOTAL KNEE IMPLANTS PRESENT IN THE 84 PATIENTS. RESULTS: A GREATER PROPORTION OF FRACTURES OCCURRED DISTAL TO THE STEM IN IPFF PATIENTS VERSUS PFF PATIENTS, AND THE TYPES OF FRACTURES WERE DISTINCTLY DIFFERENT BETWEEN THE STUDY AND CONTROL GROUPS. THE PRESENCE OF AN IPSILATERAL TKA AFFECTS THE LOCATION OF PFF WITH MORE FRACTURES OCCURRING DISTAL TO THE STEM. A GREATER PROPORTION OF BENDING TYPE FRACTURES OCCURRED WHEN AN IPSILATERAL TKA WAS PRESENT. THESE UNSTABLE FRACTURES OFTEN REQUIRE MORE COMPLEX SURGERY. INTER-PROSTHETIC FEMORAL FRACTURES (IPFF) BY MODEL: 3: C STEM AMT, 4: C STEM CLASSIC, 26: CHARNLEY, 4: CORAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632684 UNK HIP FEMORAL STEM C-STEM FEMORAL STEM LPH DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention