BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP ACETABULAR LINER POLY

    MDR report key: 15594950 · Received October 13, 2022

    Report

    Report Number
    1818910-2022-20348
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    June 19, 2020
    Report Date
    October 13, 2022
    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). THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. 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: KWON YM, MAHAJAN J, TIRUMALA V, OGANESYAN R, YEO I, KLEMT C. SENSITIVITY AND SPECIFICITY OF SERUM AND SYNOVIAL FLUID MARKERS IN DIAGNOSIS OF INFECTION IN HEAD-NECK TAPER CORROSION OF METAL-ON-POLYETHYLENE TOTAL HIP ARTHROPLASTY. J ARTHROPLASTY. 2020 DEC;35(12):3737-3742. DOI: 10.1016/J.ARTH.2020.06.058. EPUB 2020 JUN 23. PMID: 32665158. OBJECTIVE AND METHODS: THE ACCURATE DIAGNOSIS OF PERIPROSTHETIC JOINT INFECTION (PJI) IN THE SETTING OF ADVERSE LOCAL TISSUE REACTIONS IN PATIENTS WITH METAL-ON-POLYETHYLENE (MOP) TOTAL HIP ARTHROPLASTY (THA) SECONDARY TO HEAD-NECK TAPER JUNCTION CORROSION IS CHALLENGING AS IT FREQUENTLY HAS THE APPEARANCE OF PURULENCE. THE AIM OF THIS STUDY IS TO EVALUATE THE UTILITY OF ERYTHROCYTE SEDIMENTATION RATE (ESR), C-REACTIVE PROTEIN (CRP), AND SYNOVIAL FLUID MARKERS IN DIAGNOSING PJI IN FAILED MOP THA DUE TO HEAD-NECK TAPER CORROSION. THE AUTHORS TOOK 89 PATIENTS WHO WERE REVISED FOR SYMPTOMATIC ADVERSE LOCAL TISSUE REACTION (ALTR) AND DIVIDED THEM BY THE 11 WHOSE PRE-OPERATIVE HIP ASPIRATIONS DETERMINED PJI, AND 78 WHO WERE DETERMINED TO ONLY HAVE ALTR. MULTIPLE MANUFACTURERS WERE INCLUDED IN THESE PATIENT SAMPLES, OF WHICH 9 HIPS WITH DEPUY PINNACLE CUPS AND POLYETHYLENE LINERS, PAIRED WITH DEPUY SUMMIT FEMORAL STEMS AND METAL HEADS, WERE REPRESENTED. THE AUTHORS DID NOT BREAKDOWN WHICH MANUFACTURERS WERE INCLUDED IN THE PJI GROUP, AND WHICH ONES HAD ONLY ALTR. ALL INFECTED CASES WERE EXPLANTED AND HAD ANTIBIOTIC SPACERS PLACED. TREATMENT SPECIFICS FOR THE 78 ALTR ONLY CASES WERE NOT PROVIDED. RESULTS: THE RESULTS OF THIS STUDY SUGGEST THAT ESR AND CRP ARE USEFUL IN EXCLUDING PJI, WHEREAS BOTH SYNOVIAL WHITE BLOOD CELL COUNT AND NEUTROPHIL PERCENTAGE IN HIP ASPIRATE ARE USEFUL MARKERS FOR DIAGNOSING INFECTION IN MOP THA PATIENTS WITH HEAD-NECK TAPER CORROSION ASSOCIATED ADVERSE LOCAL TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583114 UNK HIP ACETABULAR LINER POLY ACETABULAR LINER LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention