BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL STEM CHARNLEY

    MDR report key: 15041905 · Received July 18, 2022

    Report

    Report Number
    1818910-2022-13243
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    January 1, 2022
    Report Date
    July 18, 2022
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). LITERATURE REVIEW CLARIFICATION: OF THE QTY 39 DEPUY PRIMARY STEMS THAT WERE FEMORAL FRACTURES WITH IMPLANT LOOSENING IT IS NOTED THAT QTY 32 WERE CHARNLEY (CAPTURED BY (B)(4)) AND QTY 7 WERE C-STEMS (CAPTURED BY (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. LITERATURE CITATION: DIAZ-DILERNIA F, SLULLITEL PA, OÑATIVIA JI, COMBA FM, PICCALUGA F, BUTTARO MA. IMPACTION BONE GRAFTING OR UNCEMENTED MODULAR STEMS FOR THE TREATMENT OF TYPE B3 PERIPROSTHETIC FEMORAL FRACTURES? A COMPLICATION RATE ANALYSIS. J ARTHROPLASTY. 2019 SEP;34(9):2051-2057. DOI: 10.1016/J.ARTH.2019.04.047. EPUB 2019 MAY 14. PMID: 31160153. OBJECTIVE/METHODS/STUDY DATA: AUTHORS RETROSPECTIVELY STUDIED 54 B3 PFFS OPERATED BETWEEN 2000 AND 2016, COMPARING THE COMPLICATION RATE OF 33 PATIENTS TREATED WITH THE IBG (IMPACTION BONE GRAFTING) TECHNIQUE (GROUP A) WITH 21 PATIENTS TREATED WITH A DFMS (UNCEMENTED DISTALLY FIXED MODULAR STEM) (GROUP B). MEDIAN FOLLOW-UP OF GROUPS A AND B WERE 75 MONTHS (INTERQUARTILE RANGE [IQR], 36-111 MONTHS) AND 55 MONTHS (IQR, 32-73 MONTHS), RESPECTIVELY (P ¼ .008). MEDIAN AGE OF GROUPS A AND B WERE 78 YEARS (IQR, 74-83 YEARS) AND 81 YEARS (IQR, 74-86 YEARS), RESPECTIVELY (P ¼ .30). MEDIAN GRADE OF ENDOKLINK FEMORAL BONE DEFECT WAS 3 (IQR, 3-3) FOR BOTH GROUPS (P ¼ .11). AUTHORS PERFORMED A MULTIPLE REGRESSION ANALYSIS TO DETERMINE RISK FACTORS FOR COMPLICATIONS INCLUDING THE FOLLOWING VARIABLES: AGE, INITIAL DIAGNOSIS, AND SURGICAL TECHNIQUE. THE ARTICLE PROVIDES THAT THE ORIGINAL STEMS CONSISTED OF IDENTIFIED TOTAL QTY 39 DEPUY STEMS WITH THE REMAINING QTY 15 AS NON-DEPUY STEMS ALL REQUIRING REVISION FOR PERIPROSTHETIC FEMORAL FRACTURES WITH IMPLANT LOOSENING. THE QTY 54 REVISIONS ARE THEN SEPARATED IN TWO GROUPS BASED UPON REVISION TECHNIQUE AS GROUP A (IBG GROUP) AND GROUP B (DFMS GROUP). GROUP A CONSISTS OF QTY 21 DEPUY STEMS FIXATED WITH PRIMARY IMPACTION GRAFTING INSTRUMENTS AND CMW BONE CEMENT WITH GENTAMICIN (QTY 1 CHARNLEY AND QTY 20 C-STEM). THE REMAINING 12 CASES IN GROUP A RECEIVED NON-DEPUY RECONSTRUCTIVE SYSTEMS (EXCHANGE REVISION INSTRUMENT SYSTEMS BY STRYKER, EXETER STEM BY STRYKER AND SIMPLEX WITH TOBRAMYCIN CEMENT BY STRYKER). DURING THE RECONSTRUCTIVE SURGERY, CERCLAGE WIRES AND METAL MESHES WERE USED AS NECESSARY, BUT THE ARTICLE DOES NOT IDENTIFY THE MANUFACTURER OF THESE DEVICES. GROUP B ONLY CONTAINS NON-DEPUY DEVICES. THE FEMORAL HEAD ACETABULAR COMPONENTS ARE NOT IDENTIFIED BUT THE ARTICLE REPORTS OF POLYMETHYLMETHACRYLATE DEBRIS BEING REMOVED DURING INITIAL REVISION SURGERIES IMPLYING THE LINER IS A POLY MATERIAL. THIS COMPLAINT CAPTURES THE ADVERSE EVENTS THAT CAN BE ASSOCIATED WITH IDENTIFIED DEPUY PRODUCTS. ANY ADDITIONAL INFORMATION PROVIDED VIA FOLLOW UP ACTIVITY WITH AUTHOR(S) WILL BE REPORTED. THE ARTICLE DOES NOT IDENTIFY THE MANUFACTURER DEVICES FOR EVERY ADVERSE EVENT FOR GROUP A WITH THE EXCEPTION OF A FEW OCCURRENCES. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (IDENTIFIED DEVICE MANUFACTURER DEPUY): PRIMARY GROUP: QTY 39 PERIPROSTHETIC FEMORAL FRACTURE WITH DEPUY PRIMARY STEMS LOOSENING (INTERFACE UNKNOWN AND ORIGINAL CEMENT MANUFACTURER IS NOT IDENTIFIED) TREATED WITH REVISION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (IDENTIFIED DEVICE MANUFACTURER DEPUY IN GROUP A): QTY 1 CHARNLEY STEM FEMORAL LOOSENING (INTERFACE UNKNOWN) AT 47 MONTHS POST REVISION SURGERY TREATED WITH REPEAT REVISION SURGERY. QTY 1 C-STEM WITH ATRAUMATIC VANCOUVER TYPE B1 FEMORAL FRACTURE TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION. QTY 3 C-STEM WITH ATRAUMATIC FEMORAL STEM FRACTURES OCCURRING AT MEDIAN OF 60 MONTHS AND TREATED WITH REVISION TO A MODULAR CEMENTLESS STEM IN 2 CASES AND REPEATED IBG TECHNIQUE IN REMAINING 1. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS (UNIDENTIFIED DEVICE MANUFACTURER IN GROUP A): QTY 4 INFECTIONS AT MEDIAN 17 MONTHS TREATED WITH 2-STAGE PROCEDURE WITH NO RECURRENCES. QTY 2 DISLOCATIONS (1 TREATED WITH CLOSED REDUCTION AND ABDUCTION BRACE FOR 6 WEEKS; THE OTHER TREATED WITH ANOTHER REVISION SURGERY TO A CEMENTED CONSTRAINED LINER AT 10 MONTHS POST-OP). QTY 1 ASYMPTOMATIC GREATER TROCHANTERIC NONUNION TREATED CONSERVATIVELY QTY 6 CASES OF UP TO 2 MM SUBSIDENCE WITH NO TREATMENT. QTY 4 DEEP VEIN THROMBOSIS (TREATMENT NOT SPECIFIED). QTY 2 PNEUMONIA DEVELOPMENT DURING HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960443 UNK HIP FEMORAL STEM CHARNLEY FEMORAL STEM LPH DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention