BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL SLEEVE SROM

    MDR report key: 15073931 · Received July 21, 2022

    Report

    Report Number
    1818910-2022-13628
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    June 14, 2022
    Report Date
    July 21, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: HUANG Y, ZHOU Y, SHAO H, CHU Y, GU J, LI H. TOTAL HIP ARTHROPLASTIES FOR HARTOFILAKIDIS TYPE C1 AND C2 HIGH HIP DISLOCATIONS DEMONSTRATE SIMILAR SURVIVORSHIP AND CLINICAL FUNCTION AT MINIMUM 10-YEAR FOLLOW-UP WITH CEMENTLESS IMPLANTS. J ARTHROPLASTY. 2022 JUN 14:S0883-5403(22)00623-4. DOI: 10.1016/J.ARTH.2022.06.005. EPUB AHEAD OF PRINT. PMID: 35709909. OBJECTIVE AND METHODS: THIS STUDY AIMED TO DETERMINE THE DIFFERENCES IN SURVIVORSHIP, CLINICAL FUNCTION, AND COMPLICATIONS AMONG PATIENTS WHO HAVE HARTOFILAKIDIS TYPE C1 OR C2 DEVELOPMENTAL DYSPLASIA OF THE HIPS AND UNDERWENT TOTAL HIP ARTHROPLASTY (THA) WITH CEMENTLESS IMPLANTS PLACED IN 84 HIPS BETWEEN JANUARY 12, 2002 AND SEPTEMBER 30, 2011. IN THIS STUDY, THE AUTHORS UTILIZED 70 S-ROM STEMS AND SLEEVES, 5 SUMMIT STEMS, AND 2 AML STEMS ALL PAIRED WITH AN ASSUMED DEPUY FEMORAL HEAD AS WELL AS 7 COMPETITOR STEM/HEAD PAIRINGS. ON THE ACETABULAR SIDE. THERE WERE 33 DURALOC CUPS/LINERS AND 51 COMPETITOR CUP/LINERS COMBINATIONS USED IN THE STUDY. THIS COMPLAINT WILL CAPTURE THE REPORTED ADVERSE EVENTS/COMPLICATIONS ASSOCIATED WITH THE STEM/HEAD PAIRINGS WITH A QUANTITY OF ONE AS IT IS REASONABLE TO ASSUME DEPUY PRODUCTS COULD BE ASSOCIATED, BUT THE ACTUAL NUMBER IS UNKNOWN. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY FEMORAL STEM, DEPUY FEMORAL HEAD, SROM FEMORAL SLEEVE ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: INTRAOPERATIVE FEMORAL FRACTURE TREATED WITH CERCLAGE 3 FEMORAL STEM REVISIONS FOR LOOSENING: 1 ASSOCIATED WITH POSTOPERATIVE FEMORAL FRACTURE, ONE ASSOCIATED WITH NON-UNION OF THE FEMORAL OSTEOTOMY. 4 POST OPERATIVE PERIPROSTHETIC FEMORAL FRACTURES TREATED WITH ORIF OR REVISION. 7 DISLOCATIONS TREATED WITH CLOSED REDUCTION. 1 INFECTION: TREATMENT UNKNOWN. FIG 3: 31-YEAR-OLD FEMALE PATIENT RECEIVED A FEMORAL CERCLAGE TO TREAT AN INTRAOPERATIVE FEMORAL FRACTURE DURING S-ROM STEM/SLEEVE IMPLANTATION. THE PATIENT WAS LATER REVISED TO TREAT LOOSENING AND MIGRATION OF THE FEMORAL STEM/SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1719829 UNK HIP FEMORAL SLEEVE SROM FEMORAL SLEEVE LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention