BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 16437454 · Received February 24, 2023

    Report

    Report Number
    1818910-2023-04470
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    July 8, 2022
    Report Date
    February 24, 2023
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4-THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. (B)(4). DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TOTAL HIP ARTHROPLASTY WITH SUBTROCHANTERIC OSTEOTOMY FOR DEVELOPMENTAL HIP DYSPLASIA: A LONG-TERM FOLLOW-UP STUDY. PALUMBO BT, SALOMON K, SULLIVAN A, SIMON P, LYONS S, BERNASEK TL. ARTHROPLASTY TODAY. (B)(6) 2022 ;17:101-106. DOI: 10.1016/J.ARTD.2022.07.004. COLLECTION 2022 OCT. OBJECTIVE AND METHODS: THE AIM OF THIS STUDY IS TO ANALYZE THE LONG-TERM OUTCOMES AND SURVIVORSHIP OF AN SHORTENING DEROTATIONAL OSTEOTOMY (SDO)-THA COHORT. THE AUTHORS RETROSPECTIVELY REVIEWED ALL PATIENTS WHO UNDERWENT CEMENTLESS THA WITH FEMORAL OSTEOTOMY DUE TO CROWE I-IV DDH BETWEEN 1991 AND 2001. REVIEW RESULTED IN 24 SDO-THA CASES IN 20 PATIENTS WITH A MEAN FOLLOW-UP OF 19 YEARS (RANGE, 8-27 YEARS). OVERALL SURVIVORSHIP WAS 67%THE STUDY DID NOT BREAK DOWN CASES BY PATIENT SPECIFIC DEMOGRAPHIC DATA, NOR RELATE SPECIFIC ADVERSE EVENTS TO PRODUCT MANUFACTURERS INVOLVED IN THOSE HIPS. ALL FEMORAL COMPONENTS WERE NOTED TO BE DEPUY. OF THE ACETABULAR COMPONENTS, 9 WERE DEPUY, 15 WERE COMPETITOR PRODUCTS. RESULTS: THA WITH SDO CAN PRODUCE DURABLE LONG-TERM OUTCOMES FOR THE PATIENT WITH DDH. COMPLICATIONS: POLY WEAR/OSTEOLYSIS / ACETABULAR REVISION: 5 ACETABULAR LOOSENING/REVISION: 2 INSTABILITY/ACETABULAR REVISION: 1 INSTABILITY WITHOUT REVISION:3 DISLOCATION TREATED WITH ORIF:1 DISLOCATION TREATED WITH CLOSED REDUCTION: 1 NONDISPLACED FEMORAL FRACTURE TREATED WITH CABLING OF FEMORAL FRACTURE (NO COMPONENT REVISION):1

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022957 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention