BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP ACETABULAR CONSTRUCT PINNACLE

    MDR report key: 22235862 · Received June 17, 2025

    Report

    Report Number
    1818910-2025-09901
    Event Type
    Injury
    Date Received
    June 17, 2025
    Date of Event
    June 28, 2024
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. ADDITIONAL NARRATIVE: 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 REPORT, A FOLLOW-UP REPORT 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: DENG Z, DAI H, SONG C, LUO F, WU Y, ZHANG R, LUO J, XU J. COMPARISON OF POSTOPERATIVE OUTCOMES BETWEEN ENDOSCOPY ASSISTED MINIMAL INVASIVE DIRECT ANTERIOR APPROACH AND BIKINI DIRECT ANTERIOR APPROACH IN TOTAL HIP ARTHROPLASTY. ARCH ORTHOP TRAUMA SURG. 2024 AUG;144(8):3705-3713. DOI: 10.1007/S00402-024-05419-X. EPUB 2024 JUN 28. PMID: 38940984. OBJECTIVE/METHODS/STUDY DATA: THIS RETROSPECTIVE STUDY WAS DESIGNED TO EVALUATE TWO DIFFERENT TYPES OF DAA: (1) THE EFFECT OF ENDO-DAA ON WOUND AESTHETICS COMPARED WITH BIKINI-DAA; (2) RADIOLOGICAL DIFFERENCES IN IMPLANT POSITION WHEN USING ENDO-DAA COMPARED TO BIKINI-DAA; (3) DIFFERENCES IN FUNCTIONAL OUTCOMES AND COMPLICATIONS BETWEEN BIKINI-DAA AND ENDO-DAA. A TOTAL OF 402 PATIENTS WERE INCLUDED IN THE STUDY. THESE PATIENTS WERE DIVIDED INTO TWO GROUPS. ENDO-DAA GROUP CONSIST OF 195 PATIENTS (96 MALE AND 99 FEMALE) WITH A MEAN AGE OF 60.9 ± 10.8 WHILE BIKINI-DAA GROUP CONSIST OF 207 PATIENTS (108 MALE AND 99 FEMALE) WITH A MEAN AGE OF 61.5 ± 13.3. THESE PATIENTS WERE TREATED WITH (IMPLANT: PINNACLE ACETABULAR CUP SYSTEM AND CORAIL/TRI-LOCK HIP SYSTEM BY DEPUY, JOHNSON AND JOHNSON, USA). ALL PATIENTS WERE FOLLOWED UP FOR MORE THAN 1 YEAR. 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/TRI-LOCK HIP SYSTEM. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT CORAIL (QTY 17). ENDO-DAA GROUP 1 HIP WITH FEMORAL NECK FRACTURE AFTER SURGERY. NO INTERVENTION PROVIDED. 1 DEEP VEIN THROMBOSIS AFTER SURGERY AND DISAPPEARED AFTER 4 WEEKS OF ORAL ANTICOAGULANT ACCOMPANIED BY APPROPRIATE ACTIVITIES. 1 SUPERFICIAL WOUND INFECTION WAS TREATED WITH ANTIBIOTICS BASED ON ANTIBIOGRAM. 1 WOUND DEHISCENCE OCCURRED 2 DAYS POSTOPERATIVELY, WHICH HEALED AFTER SURGICAL DEBRIDEMENT AND ANTIBIOTIC TREATMENT. BIKINI-DAA GROUP 1 RECURRENT DISLOCATION WAS RECORDED ONE MONTH POSTOPERATIVELY AND TREATED WITH REOPERATION. 2 DEEP VEIN THROMBOSIS WAS FOUND WITHIN 3 DAYS AFTER SURGERY, WHICH RECOVERED WITH ADHERENCE TO ANTICOAGULANTS. 2 SUPERFICIAL WOUND INFECTION WAS RECORDED 3 DAYS POSTOPERATIVELY AND TREATED WITH ANTIBIOTICS. 1 PATIENT WITH WOUND DEHISCENCE WAS TREATED WITH DISINFECTION DAILY, LASTING FOR 2 WEEKS. 2 CASES OF WOUND DEHISCENCE WERE TREATED WITH DEBRIDEMENT. 1 HEMATOMA RELIVED WITHIN 2 WEEKS. 1 THIGH PAIN RELIEVED WITHIN 2 WEEKS. 2 LATERAL FEMORAL CUTANEOUS NERVE (LFCN) DYSESTHESIA (PRESENTED AT 2 DAYS) RECOVERED 3 WEEKS LATER. 1 REOPERATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP ACETABULAR CONSTRUCT PINNACLE (QTY 17). ENDO-DAA GROUP 1 HIP WITH FEMORAL NECK FRACTURE AFTER SURGERY. NO INTERVENTION PROVIDED. 1 DEEP VEIN THROMBOSIS AFTER SURGERY AND DISAPPEARED AFTER 4 WEEKS OF ORAL ANTICOAGULANT ACCOMPANIED BY APPROPRIATE ACTIVITIES. 1 SUPERFICIAL WOUND INFECTION WAS TREATED WITH ANTIBIOTICS BASED ON ANTIBIOGRAM. 1 WOUND DEHISCENCE OCCURRED 2 DAYS POSTOPERATIVELY, WHICH HEALED AFTER SURGICAL DEBRIDEMENT AND ANTIBIOTIC TREATMENT. BIKINI-DAA GROUP 1 RECURRENT DISLOCATION WAS RECORDED ONE MONTH POSTOPERATIVELY AND TREATED WITH REOPERATION. 2 DEEP VEIN THROMBOSIS WAS FOUND WITHIN 3 DAYS AFTER SURGERY, WHICH RECOVERED WITH ADHERENCE TO ANTICOAGULANTS 2 SUPERFICIAL WOUND INFECTION WAS RECORDED 3 DAYS POSTOPERATIVELY AND TREATED WITH ANTIBIOTICS. 1 PATIENT WITH WOUND DEHISCENCE WAS TREATED WITH DISINFECTION DAILY, LASTING FOR 2 WEEKS. 2 CASES OF WOUND DEHISCENCE WERE TREATED WITH DEBRIDEMENT. 1 HEMATOMA RELIVED WITHIN 2 WEEKS. 1 THIGH PAIN RELIEVED WITHIN 2 WEEKS. 2 LATERAL FEMORAL CUTANEOUS NERVE (LFCN) DYSESTHESIA (PRESENTED AT 2 DAYS) RECOVERED 3 WEEKS LATER. 1 REOPERATION. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK HIP FEMORAL CONSTRUCT TRI-LOCK (QTY 17). ENDO-DAA GROUP 1 HIP WITH FEMORAL NECK FRACTURE AFTER SURGERY. NO INTERVENTION PROVIDED. 1 DEEP VEIN THROMBOSIS AFTER SURGERY AND DISAPPEARED AFTER 4 WEEKS OF ORAL ANTICOAGULANT ACCOMPANIED BY APPROPRIATE ACTIVITIES. 1 SUPERFICIAL WOUND INFECTION WAS TREATED WITH ANTIBIOTICS BASED ON ANTIBIOGRAM. 1 WOUND DEHISCENCE OCCURRED 2 DAYS POSTOPERATIVELY, WHICH HEALED AFTER SURGICAL DEBRIDEMENT AND ANTIBIOTIC TREATMENT. BIKINI-DAA GROUP 1 RECURRENT DISLOCATION WAS RECORDED ONE MONTH POSTOPERATIVELY AND TREATED WITH REOPERATION. 2 DEEP VEIN THROMBOSIS WAS FOUND WITHIN 3 DAYS AFTER SURGERY, WHICH RECOVERED WITH ADHERENCE TO ANTICOAGULANTS. -2 SUPERFICIAL WOUND INFECTION WAS RECORDED 3 DAYS POSTOPERATIVELY AND TREATED WITH ANTIBIOTICS. 1 PATIENT WITH WOUND DEHISCENCE WAS TREATED WITH DISINFECTION DAILY, LASTING FOR 2 WEEKS. 2 CASES OF WOUND DEHISCENCE WERE TREATED WITH DEBRIDEMENT. 1 HEMATOMA RELIVED WITHIN 2 WEEKS. 1 THIGH PAIN RELIEVED WITHIN 2 WEEKS. 2 LATERAL FEMORAL CUTANEOUS NERVE (LFCN) DYSESTHESIA (PRESENTED AT 2 DAYS) RECOVERED 3 WEEKS LATER. 1 REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520747 UNKNOWN HIP ACETABULAR CONSTRUCT PINNACLE PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention