BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 14931352 · Received July 6, 2022

    Report

    Report Number
    1818910-2022-12378
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    January 11, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 KOBAYASHI K, OSAKI M, KIDERA K, AIT-SI-SELMI T, RAMOS-PASCUAL S, SAFFARINI M, BONNIN MP. STEM-BONE CONTACT PATTERNS OF A LONG STRAIGHT TAPERED UNCEMENTED STEM FOR PRIMARY THA. ARCH ORTHOP TRAUMA SURG. 2022 JAN 11. DOI: 10.1007/S00402-021-04273-5. EPUB AHEAD OF PRINT. PMID: 35013767. OBJECTIVE AND METHODS: THIS STUDY AIMED TO INVESTIGATE STEM-BONE CONTACT PATTERNS OF A LONG STRAIGHT-TAPERED UNCEMENTED STEM FOLLOWING PRIMARY THA, AND TO DETERMINE WHETHER THESE CONTACT PATTERNS ARE RELATED TO PREOPERATIVE FEMORAL MORPHOLOGY AND WHETHER THEY INFLUENCE POSTOPERATIVE OUTCOMES. THE AUTHORS REVIEWED A CONTINUOUS SERIES OF 60 HIPS (55 PATIENTS) THAT UNDERWENT PRIMARY THA USING THE CORAIL/PINNACLE DEVICES (DEPUY, LEEDS, UK). THE ACETABULAR LINER AND FEMORAL HEADS ARE NOT SPECIFIED BUT ASSUMED TO BE DEPUY PRODUCTS. PATIENTS WERE EVALUATED PRE- AND POST-OPERATIVELY USING THE JAPANESE ORTHOPAEDIC ASSOCIATION (JOA) SCORE. THE AUTHORS CONCLUDED THAT THE STEM-BONE CONTACT PATTERNS OF A LONG STRAIGHT-TAPERED UNCEMENTED STEM ARE RELATED TO PREOPERATIVE FEMORAL MORPHOLOGY, BUT DO NOT INFLUENCE SHORT-TERM POSTOPERATIVE OUTCOMES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: PINNACLE CUP, CORAIL STEM, UNKNOWN HEAD AND LINER ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS ASSOCIATED WITH DEPUY DEVICES: 1 REPORT OF RECURRENT DISLOCATION ATTRIBUTED TO A MALPOSITIONED CUP. TREATMENT WAS A CLOSED REDUCTION AND 3 MONTHS IN AN UNSPECIFIED PROTECTIVE HIP BRACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620338 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention UNK HIP ACETABULAR CUP PINNACLE| UNKNOWN HIP ACETABULAR LINERS| UNKNOWN HIP FEMORAL HEAD