BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP ACETABULAR LINER CERAMIC

    MDR report key: 22829363 · Received August 18, 2025

    Report

    Report Number
    1818910-2025-14375
    Event Type
    Injury
    Date Received
    August 18, 2025
    Date of Event
    September 21, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. ADDITIONAL NARRATIVE: D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. 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. 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KIM YH, PARK JW, JANG YS, KIM EJ. LONG-TERM CLINICAL RESULTS AND PATIENT SATISFACTION OF A METAPHYSEAL-ENGAGING ANATOMIC CEMENTLESS FEMORAL COMPONENT IN TOTAL HIP ARTHROPLASTY. INT ORTHOP. 2024 DEC;48(12):3127-3137. DOI: 10.1007/S00264-024-06322-1. EPUB 2024 SEP 21. PMID: 39305314. OBJECTIVE/METHODS/STUDY DATA: THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE LONG-TERM RESULTS (A MINIMUM OF 21 YEARS) OF A METAPHYSEAL-ENGAGING ANATOMIC CEMENTLESS TOTAL HIP PROSTHESIS IN PATIENTS AGED < 50 YEARS AT THE TIME OF THEIR THA. BETWEEN NOVEMBER 1995 TO FEBRUARY 2001, A TOTAL OF 360 PATIENTS (498 HIPS), SPECIFICALLY 212 MEN AND 148 WOMEN. THE MEAN AGE OF THE PATIENTS AT THE TIME OF THEIR THA WAS 45.8±8.1 YEARS. A CEMENTLESS DURALOC ACETABULAR COMPONENT (DEPUY, WARSAW, IN, USA) WAS USED IN ALL HIPS. AN ALUMINA CERAMIC LINER WITH A 28-MM INTERNAL DIAMETER (BIOLOX-FORTE; CERAMTEC, PLOCHINGEN, GERMANY) WAS USED IN ALL HIPS REGARDLESS OF THE EXTERNAL DIAMETER OF THE ACETABULAR COMPONENT, WHICH RANGED FROM 48 TO 58 MM. THE ACETABULAR COMPONENT WAS INTENDED TO BE FIXED WITH AN INCLINATION ANGLE BETWEEN 40° AND 45° AND ANTEVERSION BETWEEN 25° AND 35°. ALL PATIENTS RECEIVED AN IMMEDIATE POSTOPERATIVE STABILITY (IPS) (DEPUY, LEEDS, UNITED KINGDOM) CEMENTLESS FEMORAL STEM WITH A 28-MM ALUMINA FORTE CERAMIC FEMORAL HEAD (BIOLOX-FORTE; CERAMTEC). THE MEAN FOLLOW-UP WAS 25.2 YEAR (RANGE 21¿28 YEARS). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES DURALOC ACETABULAR COMPONENT AND IMMEDIATE POSTOPERATIVE STABILITY (IPS) FEMORAL STEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR LINER CERAMIC (QTY 68): N=6; DISLOCATION = TWO OF WHICH WAS TREATED SUCCESSFULLY WITH CLOSED REDUCTION AND AN ABDUCTION BRACE FOR THREE MONTHS. THE REMAINING FOUR HIPS (0.8%) REQUIRED REVISION OF THE ACETABULAR COMPONENT. CLICKING SOUND IN 40 HIPS (8%) AND A SQUEAKING SOUND IN 22 HIPS (4%). NO HIP WAS REVISED FOR A SQUEAKING OR CLICKING SOUND. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL HEAD CERAMIC (QTY 68): N=6; DISLOCATION = TWO OF WHICH WAS TREATED SUCCESSFULLY WITH CLOSED REDUCTION AND AN ABDUCTION BRACE FOR THREE MONTHS. THE REMAINING FOUR HIPS (0.8%) REQUIRED REVISION OF THE ACETABULAR COMPONENT. CLICKING SOUND IN 40 HIPS (8%) AND A SQUEAKING SOUND IN 22 HIPS (4%). NO HIP WAS REVISED FOR A SQUEAKING OR CLICKING SOUND. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CUP DURALOC (QTY 1): - MEAN INCLINATION OF ACETABULAR COMPONENT WAS 44.1° (39°-53°); NO INTERVENTION PROVIDED - MEAN ANTEVERSION OF ACETABULAR COMPONENT WAS 22.8° (19°-29°); NO INTERVENTION PROVIDED ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT DURALOC (QTY 504): N=464 GRADE 1 STRESS SHIELDING = NO TREATMENT PROVIDED N=34 GRADE 2 STRESS SHIELDING = NO TREATMENT PROVIDED N=6; DEVELOPED INFECTION = SIX ACETABULAR COMPONENTS WERE REVISED FOR INFECTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT (QTY 506): N=464 GRADE 1 STRESS SHIELDING = NO TREATMENT PROVIDED N=34 GRADE 2 STRESS SHIELDING = NO TREATMENT PROVIDED N=6; DEVELOPED INFECTION = THREE FEMORAL COMPONENTS WERE REVISED FOR INFECTION (N=2) PERIPROSTHETIC FRACTURE AT THE TIP OF THE STEM AND WAS REVISED BY USING AN EXTENSIVELY POROUS COATING LONG FEMORAL STEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL STEM (QTY 25) N=25 STEMS THAT WERE IN VARUS (15 STEMS) AND VALGUS (10 STEMS) WITH PEC IMPLANT MISPOSITIONING = NO TREATMENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680248 UNK HIP ACETABULAR LINER CERAMIC CERAMIC ACETABULAR LINER LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention