BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 22492935 · Received July 14, 2025

    Report

    Report Number
    1818910-2025-11942
    Event Type
    Injury
    Date Received
    July 14, 2025
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE.

    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. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF THE POST-MARKET SURVEILLANCE. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT: THE DEVICE LOT NUMBER IS UNKNOWN, THEREFORE A¿DEVICE HISTORY REVIEW COULD NOT BE PERFORMED.¿ IF THE LOT/SERIAL NUMBER BECOMES AVAILABLE, THE RECORD WILL BE RE-ASSESSED.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: HONG JX, DRAVID A, SANKAR WN, SHETH NP. PEDIATRIC PATIENTS UNDERGOING TOTAL HIP ARTHROPLASTY: A SINGLE-CENTER EXPERIENCE AT AVERAGE 5.3-YEAR FOLLOW-UP. J ARTHROPLASTY. 2025 MAR 17:S0883-5403(25)00229-3. DOI: 10.1016/J.ARTH.2025.03.017. EPUB AHEAD OF PRINT. PMID: 40107578. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY IS TO REPORT ON A SINGLE SURGEON'S CONSECUTIVE COHORT OF PEDIATRIC PATIENTS UNDER 21 YEARS OF AGE WHO HAD A MEAN FOLLOW-UP OF 5.3 YEARS AND WHO HAVE UNDERGONE THA. TO DELINEATE THE PREVALENCE OF ETIOLOGIES RESULTING IN THE NEED FOR A THA AND REPORT ON THE RATE OF COMPLICATIONS, REOPERATIONS, AND NEED FOR REVISION. TO ALSO REPORT ON CLINICAL OUTCOMES AND IMPLANT SURVIVORSHIP FOLLOWING THA WITH MODERN ALTERNATIVE BEARINGS. BETWEEN MARCH 12, 2013 AND MARCH 30, 2023, A TOTAL OF 92 HIPS (74 PATIENTS) MET THE INCLUSION CRITERIA. THE MEAN AGE AT SURGERY WAS 16 YEARS (RANGE, 11 TO 21), AND (36 MALE AND 38 FEMALE). ALL PATIENTS RECEIVED A CEMENTLESS STEM, AND IMPLANT CHOICE WAS MADE BASED ON BONE QUALITY AND FEMORAL MORPHOLOGY USING THE DORR CLASSIFICATION. 2 PATIENTS WERE TREATED WITH LIP LINER (DEPUY), 14 PATIENTS TREATED WITH S-ROM (DEPUY), 1 PATIENT TREATED WITH CORAIL (DEPUY) AND THE REST WERE TREATED FROM THE COMPETITOR'S DEVICE. ALL PATIENTS WERE EVALUATED AT 2 WEEKS, 6 WEEKS, 6 MONTHS, AND 12 MONTHS, AND SUBSEQUENTLY ON AN ANNUAL BASIS; NO PATIENTS WERE LOST TO FOLLOW-UP. THE MEAN FOLLOW-UP PERIOD WAS 5.3 YEARS (RANGE,1 TO 11.2). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES S-ROM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM SROM (QTY 1). AN 18-YEAR-OLD MAN WHO HAD MORQUIO SYNDROME ALMOST 2 YEARS FOLLOWING PRIMARY TOTAL HIP ARTHROPLASTY, DEMONSTRATING RADIOLUCENCIES SURROUNDING THE FEMORAL COMPONENT AND VARUS MIGRATION OF THE STEM; THE PATIENT WAS DIAGNOSED WITH ASEPTIC FEMORAL LOOSENING. ANTERO-POSTERIOR RADIOGRAPH AT 3.2 YEARS FOLLOWING AN EXTENDED TROCHANTERIC OSTEOTOMY FOR VARUS FEMORAL REMODELING AND REVISION OF THE FEMORAL COMPONENT TO A NONMODULAR TAPERED STEM. AP, ANTEROPOSTERIOR. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL HEAD (QTY 1). A PATIENT WHO HAD CEREBRAL PALSY (1.1%) HAD TWO EPISODES OF DISLOCATION ON POSTOPERATIVE DAY 3 AND AT 7 WEEKS; THESE WERE TREATED WITH CLOSED REDUCTION AND STABILIZED USING AN ABDUCTION BRACE WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774600 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD LPH DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Required Intervention