BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CONSTRUCT PINNACLE

    MDR report key: 20673667 · Received November 13, 2024

    Report

    Report Number
    1818910-2024-23620
    Event Type
    Injury
    Date Received
    November 13, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY ORTHOPAEDICS IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY ORTHOPAEDICS HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY ORTHOPAEDICS OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY ORTHOPAEDICS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. B3: UNKNOWN EVENT. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. H3, H6: 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. 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: ROBERTS HJ, HADLEY ML, MALLINGER BD, SIERRA RJ, TROUSDALE RT, PAGNANO MW, TAUNTON MJ. A RANDOMIZED CLINICAL TRIAL OF DIRECT ANTERIOR VERSUS MINI-POSTERIOR TOTAL HIP ARTHROPLASTY: SMALL, EARLY FUNCTIONAL DIFFERENCES DID NOT LEAD TO MEANINGFUL CLINICAL DIFFERENCES AT 7.5 YEARS. J ARTHROPLASTY. 2024 SEP;39(9S1):S97-S100. DOI: 10.1016/J.ARTH.2024.05.016. EPUB 2024 MAY 11. PMID: 38735544. OBJECTIVE/METHODS/STUDY DATA: THE CURRENT STUDY AIMED TO EVALUATE WHETHER THE DIFFERENCES IN EARLY RECOVERY IN THE DAA GROUP LED TO SUSTAINED, MEANINGFUL CLINICAL DIFFERENCES IN PATIENT-REPORTED OUTCOMES BEYOND FIVE YEARS. WE ADDITIONALLY INVESTIGATED THE RATE OF COMPLICATIONS, REOPERATIONS, AND REVISIONS BETWEEN APPROACHES. BETWEEN MARCH 1, 2013 AND MAY 31, 2016, A TOTAL OF 93 PATIENTS WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE DIVIDED INTO TWO GROUPS. DIRECT ANTERIOR APPROACH (DAA) CONSIST OF 49% WOMEN WITH A MEAN AGE OF 65 YEARS OLD WHILE MINI-POSTERIOR APPROACH (MPA) CONSIST OF 49% WOMEN WITH A MEAN AGE OF 64 YEARS OLD. ALL PATIENTS RECEIVED THE SAME HEMISPHERICAL, UNCEMENTED ACETABULAR COMPONENT (PINNACLE®; DEPUY ORTHOPAEDICS, INC., WARSAW, INDIANA, USA) AND THE SAME UNCEMENTED HYDROXYAPATITE-COATED FEMORAL STEM (CORAIL®; DEPUY ORTHOPAEDICS, INC.) WITH A BIOLOX® DELTA CERAMIC FEMORAL HEAD (CERAMTEC GMBH, PLOCHINGEN, GERMANY), AND HIGHLY CROSSLINKED POLYETHYLENE ACETABULAR BEARING SURFACES. PATIENTS WERE FOLLOWED-UP FOR A MINIMUM 2-YEAR FOLLOW-UP AT A MEAN OF 7.5 YEARS POSTOPERATIVELY (RANGE, 2 TO 9 YEARS). LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES CORAIL AND PINNACLE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK - HIP FEMORAL STEM CORAIL (QTY 1): 1 FEMORAL LOOSENING THAT REQUIRED REVISION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL HEAD CERAMIC (QTY 4): 1 DISLOCATION IN DAA GROUP THAT WAS TREATED WITH CLOSED REDUCTION WITH NO FURTHER DISLOCATIONS. 3 DISLOCATIONS IN MPA GROUP, OF WHICH TWO WERE TREATED WITH CLOSED AND ONE REQUIRED REVISION TO A DUAL-MOBILITY LINER. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR LINER POLY PINNACLE (QTY 4): 1 DISLOCATION IN DAA GROUP THAT WAS TREATED WITH CLOSED REDUCTION WITH NO FURTHER DISLOCATIONS. 3 DISLOCATIONS IN MPA GROUP, OF WHICH TWO WERE TREATED WITH CLOSED AND ONE REQUIRED REVISION TO A DUAL-MOBILITY LINER. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT CORAIL AND UNK HIP ACETABULAR CONSTRUCT PINNACLE (QTY 7): 2 WOUND DEHISCENCE (BOTH TREATED WITH OPEN WOUND DEBRIDEMENT AND PRIMARY CLOSURE. 1 HAD SUPERFICIAL WOUND DEHISCENCE TREATED WITH DRESSING CHANGES AND ORAL ANTIBIOTICS THAT DID NOT REQUIRE FURTHER INTERVENTION. 2 INTRAOPERATIVE CALCAR FRACTURES TREATED WITH A CABLE, BOTH OF WHICH HAD HEALED BY 1-YEAR FOLLOW-UP. 1 ADDITIONAL PATIENT SUSTAINED A FALL AT 14 MONTHS, RESULTING IN PUBIC RAMI FRACTURES THAT HEALED WITH PROTECTED WEIGHT BEARING. 1 PATIENT DEVELOPED A DEEP VEIN THROMBOSIS TREATED MEDICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2008892 UNKNOWN HIP ACETABULAR CONSTRUCT PINNACLE PROSTHESIS, HIP, CEMENTED OR NON-POROUS, UNCEMENTED LZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention