BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HIP FEMORAL HEAD CERAMIC

    MDR report key: 19568114 · Received June 19, 2024

    Report

    Report Number
    1818910-2024-13315
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    July 20, 2023
    Report Date
    June 19, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT/LOT NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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: MARCOMINI MP, IQBAL J, BENNETT D. RARE PSEUDOTUMOR IN CERAMIC-ON-CERAMIC TOTAL HIP REPLACEMENT WITH CONCOMITANT FUNGAL PERIPROSTHETIC JOINT INFECTION: A CASE REPORT. AM J CASE REP. 2023 SEP 6;24:E941164. DOI: 10.12659/AJCR.941164. PMID: 37670458; PMCID: PMC10495539. OBJECTIVE AND METHODS: AUTHORS PRESENTED A CASE OF A WOMAN WHO SUFFERED 2 SEVERE BUT RARE COMPLICATIONS OF CERAMIC-ON-CERAMIC TOTAL HIP REPLACEMENTS: A PSEUDOTUMOR FORMATION ON A DELTA CERAMIC-ON-CERAMIC BEARING AND A FUNGAL PERIPROSTHETIC JOINT INFECTION (PJI). CASE REPORT IN EARLY 2016, A 63-YEAR-OLD WOMAN UNDERWENT AN ELECTIVE PRIMARY LEFT TOTAL HIP REPLACEMENT WITH CERAMIC-ON-CERAMIC BEARING DUE TO SEVERE OSTEOARTHRITIS. IN 2021, SHE SUFFERED TWO DEEP VEIN THROMBOSIS (DVT). ULTRASOUND (US) DOPPLER IMAGING AND MAGNETIC RESONANCE IMAGING (MRI) EXAMINED THE LEFT LOWER LIMB AND SHOWED A MASS CLOSE TO THE ILIAC VEIN. INITIALLY THOUGHT TO BE A HEMATOMA, IT WAS ULTIMATELY CONFIRMED TO BE A PSEUDOTUMOR DURING THE SECOND DVT EPISODE. REVISION SURGERY WAS PERFORMED (BEARING CHANGED TO CERAMIC-ON-POLYETHYLENE), PSEUDOTUMOR DEBULKED, AND CULTURES SENT. THE PSEUDOTUMOR WAS CONFIRMED TO BE ALVAL BY HISTOLOGY SAMPLES. HER POSITIVE CULTURE SWABS IDENTIFIED FUNGAL INFECTION, BUT THE INFECTION WAS NOT CLINICALLY CORRELATED. HISTORICALLY, THE PATIENT HAD BEEN TREATED IN 2018 FOR A DEEP BUCCAL (ORAL/DENTAL) UNCONFIRMED FUNGAL MOUTH INFECTION (UNRELATED TO HER HIP REPLACEMENT). A FEW WEEKS AFTER HER REVISION, THE PATIENT PRESENTED AGAIN WITH SYMPTOMS OF INFECTION, AND WAS TREATED WITH 2 SURGICAL DEBRIDEMENT PROCEDURES, IV ANTIBIOTICS, AND AN IMPLANT RETENTION (DAIR) PROCEDURE, IN WHICH FURTHER POSITIVE SWABS OF CANDIDA PARAPSILOSIS WERE OBTAINED. CURRENTLY, THE PATIENT IS ON CONSERVATIVE THERAPY WITH LONG-TERM ANTIFUNGAL MEDICATION SINCE SHE REFUSED A STAGED PROCEDURE DUE TO PERSONAL CIRCUMSTANCES. A 63-YEAR-OLD WOMAN EXPERIENCED THE FOLLOWING: LOT AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY TOTAL HIP DEVICES POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS ARE: UNKNOWN HIP FEMORAL STEM, UNKNOWN HIP FEMORAL HEAD CERAMIC, UNKNOWN HIP ACETABULAR LINER CERAMIC, AND UNKNOWN HIP ACETABULAR CUP. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL STEM (QTY 1) PATIENT EXPERIENCED TWO EPISODES OF DEEP VEIN THROMBOSIS, TREATED WITH ORAL MEDICATION FOR FIRST EPISODE AND THEN TREATED WITH SURGICAL IMPLANTATION OF AN EXTERNAL ILIAC VEIN STENT FOLLOWING THE SECOND EPISODE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL HEAD CERAMIC (QTY 1) PATIENT EXPERIENCED TWO EPISODES OF DEEP VEIN THROMBOSIS, TREATED WITH ORAL MEDICATION FOR FIRST EPISODE AND THEN TREATED WITH SURGICAL IMPLANTATION OF AN EXTERNAL ILIAC VEIN STENT FOLLOWING THE SECOND EPISODE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINER CERAMIC (QTY 1) PATIENT EXPERIENCED TWO EPISODES OF DEEP VEIN THROMBOSIS, TREATED WITH ORAL MEDICATION FOR FIRST EPISODE AND THEN TREATED WITH SURGICAL IMPLANTATION OF AN EXTERNAL ILIAC VEIN STENT FOLLOWING THE SECOND EPISODE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR CUP (QTY 1) PATIENT EXPERIENCED TWO EPISODES OF DEEP VEIN THROMBOSIS, TREATED WITH ORAL MEDICATION FOR FIRST EPISODE AND THEN TREATED WITH SURGICAL IMPLANTATION OF AN EXTERNAL ILIAC VEIN STENT FOLLOWING THE SECOND EPISODE. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL STEM (QTY 1) PATIENT SIMULTANEOUSLY EXPERIENCED A PERIPROSTHETIC JOINT INFECTION, AND A PSEUDOTUMOR DETERMINED TO BE ALVAL, TREATED WITH 2 SURGICAL DEBRIDEMENT & WASHOUTS, AND A REVISION OF THE HEAD AND LINER TO A CERAMIC-ON-POLY BEARING. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL HEAD CERAMIC (QTY 1) PATIENT SIMULTANEOUSLY EXPERIENCED A PERIPROSTHETIC JOINT INFECTION, AND A PSEUDOTUMOR DETERMINED TO BE ALVAL, TREATED WITH 2 SURGICAL DEBRIDEMENT & WASHOUTS, AND A REVISION OF THE HEAD AND LINER TO A CERAMIC-ON-POLY BEARING. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINER CERAMIC (QTY 1) PATIENT SIMULTANEOUSLY EXPERIENCED A PERIPROSTHETIC JOINT INFECTION, AND A PSEUDOTUMOR DETERMINED TO BE ALVAL, TREATED WITH 2 SURGICAL DEBRIDEMENT & WASHOUTS, AND A REVISION OF THE HEAD AND LINER TO A CERAMIC-ON-POLY BEARING. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR CUP (QTY 1) PATIENT SIMULTANEOUSLY EXPERIENCED A PERIPROSTHETIC JOINT INFECTION, AND A PSEUDOTUMOR DETERMINED TO BE ALVAL, TREATED WITH 2 SURGICAL DEBRIDEMENT & WASHOUTS, AND A REVISION OF THE HEAD AND LINER TO A CERAMIC-ON-POLY BEARING. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL HEAD CERAMIC (QTY 1) PATIENT EXPERIENCED A POST-OPERATIVE HIP DISLOCATION, TREATED WITH CLOSED REDUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINER CERAMIC (QTY 1) PATIENT EXPERIENCED A POST-OPERATIVE HIP DISLOCATION, TREATED WITH CLOSED REDUCTION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL STEM (QTY 1) PATIENT EXPERIENCED A POST-OPERATIVE CHRONIC WOUND SINUS DRAINAGE, WITH DELAYED WOUND HEALING TREATED WITH SURGICAL DEBRIDEMENT & WASHOUT, WITH RETENTION OF ALL IMPLANTS, AND ONGOING ORAL ANTIBIOTIC SUPPRESSION MEDICATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP FEMORAL HEAD CERAMIC (QTY 1) PATIENT EXPERIENCED A POST-OPERATIVE CHRONIC WOUND SINUS DRAINAGE, WITH DELAYED WOUND HEALING TREATED WITH SURGICAL DEBRIDEMENT & WASHOUT, WITH RETENTION OF ALL IMPLANTS, AND ONGOING ORAL ANTIBIOTIC SUPPRESSION MEDICATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR LINER CERAMIC (QTY 1) PATIENT EXPERIENCED A POST-OPERATIVE CHRONIC WOUND SINUS DRAINAGE, WITH DELAYED WOUND HEALING TREATED WITH SURGICAL DEBRIDEMENT & WASHOUT, WITH RETENTION OF ALL IMPLANTS, AND ONGOING ORAL ANTIBIOTIC SUPPRESSION MEDICATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNKNOWN HIP ACETABULAR CUP (QTY 1) PATIENT EXPERIENCED A POST-OPERATIVE CHRONIC WOUND SINUS DRAINAGE, WITH DELAYED WOUND HEALING TREATED WITH SURGICAL DEBRIDEMENT & WASHOUT, WITH RETENTION OF ALL IMPLANTS, AND ONGOING ORAL ANTIBIOTIC SUPPRESSION MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672690 UNK HIP FEMORAL HEAD CERAMIC CERAMIC FEMORAL HEAD LPH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention