BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN CUP IMPACTOR TIP 32MM

    MDR report key: 24221179 · Received January 30, 2026

    Report

    Report Number
    1818910-2026-01989
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 20, 2026
    Report Date
    January 30, 2026
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HWA
    UDI-DI
    10603295098966
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 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 REVIEW: 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.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11: ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

    Description of Event or Problem · 0

    SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED ETC WITH WEAR AND TEAR OVER TIME. THESE INSTRUMENTS DO GET REPLACED EVERY SO OFTEN DUE TO USAGE OVER TIME AS MENTIONED. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENTS DIRECT TO THE ACCOUNT: [REDACTED] [REDACTED] [REDACTED] [REDACTED] N/C PO: [REDACTED] BILL TO: [REDACTED] SHIP TO: [REDACTED] PINN STRAIGHT CUP IMPACTOR - 221750041 (221750041): NOT APPLICABLE DURALOC STR CUP IMPACTOR - 236071000 (236071000): NOT APPLICABLE PINN CUP IMPACTOR TIP 32MM - 221750007 (221750007): NOT APPLICABLE PINN POLY IMPACTOR TIP 36MM - 221750008 (221750008): NOT APPLICABLE QUICKSET EZ CLEAN GRATER HAND. - 979810000 (979810000): NOT APPLICABLE PINNACLE VERSION GUIDE - 221750044 (221750044): NOT APPLICABLE APEX HOLE ELIM TPD HEX DRIVER - 234601000 (234601000): NOT APPLICABLE SUMMIT UNIVERSAL BROACH HANDLE - 257000000 (257000000): NOT APPLICABLE UNIVERSAL STEM INSERT HANDLE - 259807460 (259807460): NOT APPLICABLE CALCAR MILL MEDIUM - 200148000 (200148000): NOT APPLICABLE MODULAR BOX OSTEOTOME - 259807530 (259807530): NOT APPLICABLE ARTICUL TR BALL GRVD 36-2 - 253150000 (253150000): NOT APPLICABLE ARTICUL TR BALL GRVD 36 +1.5 - 253151000 (253151000): NOT APPLICABLE ARTICUL TR BALL GRVD 36 +5 - 253152000 (253152000): NOT APPLICABLE ARTICUL TR BALL GRVD 36 +8.5 - 253153000 (253153000): NOT APPLICABLE ARTICUL TR BALL GRVD 36 +12 - 253154000 (253154000): NOT APPLICABLE QUICKSET DEPTH GAUGE 70MM - 227460000 (227460000): NOT APPLICABLE LIST ANY J&J PRODUCTS THAT WERE UTILIZED DURING THE CASE BUT DID NOT CONTRIBUTE TO THE REPORTED EVENT. WAS THERE ANY REPORTED PATIENT OR USER HARM? NO WAS THERE A SIGNIFICANT DELAY? NO IF AVAILABLE, PROVIDE THE PRODUCT ORDER NUMBER (PO). [REDACTED].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283468 PINN CUP IMPACTOR TIP 32MM HIP INSTRUMENTS: IMPACTOR HWA DEPUY ORTHOPAEDICS INC US 10603295098966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown