BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DJO SURGICAL

    MDR report key: 21896565 · Received April 23, 2025

    Report

    Report Number
    1644408-2025-00448
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    March 27, 2025
    Report Date
    September 29, 2025
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    LPH
    UDI-DI
    00190446673194
    PMA / PMN Number
    K203557
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A SUPPLEMENTAL REPORT TO THIS DOCUMENT AS SOON AS IT BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    SEE D4 EXPIRATION DATE, H4, H6 AND H11. THE AGENT REPORTED "THE IMPLANT INSIDE THIS PACKAGE WAS A SIZE F AND NOT A SIZE E AS IT SAYS ON THE PACKAGE. FEMALE, 45". THIS EVENT OCCURRED DURING SURGERY, NEAR THE PATIENT. NO RISK OR ADVERSE EVENT WAS REPORTED BY THE SURGEON. THERE WAS A 15-MINUTE DELAY IN SURGERY, BUT THE SURGERY WAS COMPLETED AS INTENDED. THERE WAS ANOTHER SUITABLE DEVICE AVAILABLE. THE DEVICE WAS INSPECTED PRIOR TO USE AND FOUND ACCEPTABLE. RMA EXAMINATION: THE REPORTED DEVICE(S) WAS RETURNED TO SURGICAL FOR EVALUATION. IT IS CONFIRMED A 952-28-42F WAS IN THE PACKAGING OF A 952-28-40E, REFERENCE (B)(4). TWENTY (20) PIECES OF 952-28-40E, EMPOWR ACETABULAR, DUAL MOBILITY, POLY BEARING, ID28, OD40, WERE PROCESSED ON WORK ORDER (B)(4). THESE PARTS WENT THROUGH FINAL PACK ON 12/18/2024. TWENTY (20) PIECES OF 952-28-42F, EMPOWR ACETABULAR, DUAL MOBILITY, POLY BEARING, ID28, OD42, WERE PROCESSED ON WORK ORDER (B)(4). THESE PARTS WENT THROUGH FINAL PACK ON 12/18/2024. UPON FURTHER REVIEW, BOTH WORK ORDERS WERE PROCESSED BY THE SAME OPERATOR AT PART FINAL PACK ON 12/18/24. DUE TO THE FOAM THAT IS PRESENT WITHIN THE TRAY, THE DEVICE CANNOT BE VERIFIED ONCE THE TRAY HAS BEEN SEALED. ON MARCH 4, 2025 ENCORE MEDICAL, L.P. DBA DJO SURGICAL WAS NOTIFIED THAT A 952-28-42F (LOT 2225A1124), EMPOWR ACETABULAR, DUAL MOBILITY, POLY BEARING, ID28, OD42, WAS FOUND WITHIN THE PACKAGING OF A 952-28-40E (LOT 2224A1124A), EMPOWR ACETABULAR, DUAL MOBILITY, POLY BEARING, ID28, OD40. INVESTIGATION SUMMARY: TWENTY (20) PIECES OF 952-28-40E, EMPOWR ACETABULAR, DUAL MOBILITY, POLY BEARING, ID28, OD40, LOT 2224A1124A, WERE PROCESSED ON WORK ORDER (B)(4). THESE PARTS WENT THROUGH AUTOMATED PART VERIFICATION (VEI) THROUGH FINAL PACK: QUALITY CHECK ON DECEMBER 18, 2024. TWENTY (20) PIECES OF 952-28-42F, EMPOWR ACETABULAR, DUAL MOBILITY, POLY BEARING, ID28, OD42, LOT 2225A1124, WERE PROCESSED ON WORK ORDER (B)(4). THESE PARTS WENT THROUGH AUTOMATED PART VERIFICATION (VEI) THROUGH FINAL PACK: QUALITY CHECK ON DECEMBER 18, 2024. BOTH WORK ORDERS WERE CONFIRMED TO HAVE GONE THROUGH THE VEI AND SHOWS PASSING RESULTS. THE VEI DOES A SIZE VERIFICATION TO ENSURE THE CORRECT PART IS PRESENT PRIOR TO TRAY SEALING. THE VIDEO RECORDS WITHIN THE INNER PACK WERE REVIEWED AND SHOWED THE WORK ORDERS WERE PROCESSED AT SEPARATE TIMES AND THERE THAT WAS NO EVIDENCE OF BREAKAGE IN LINE CLEARANCE. BOTH WORK ORDERS CONTAINED EVIDENCE OF POST STERILIZATION SCANNING BEING COMPLETED. THE POST STERILIZATION SCANNING CROSS REFERENCES THE LOT NUMBER WITH THE BARCODE LABEL UNDER THE TRAY, WORK ORDER, AND OUTER PACKAGING LABEL FOR EACH TRAY. THEREFORE, IT CAN BE CONCLUDED THAT THE SWAP DID NOT OCCUR DURING THE POST STERILIZATION OPERATION. THE REPORTED DEVICE WAS RETURNED TO SURGICAL FOR EVALUATION. THE TRAY BARCODE LABEL SHOW 952-28-42F WITH A BARCODE 2225A1124-1221; THE PHYSICAL PART THAT WAS SEALED WITH 952-2-842F. THE CORRECT WAS SEALED INTO THE TRAY. THE TYVEK LID LABEL SHOWS 952-28-40E, THIS LABEL IS PLACED ONTO THE TRAY AFTER STERILIZATION AND POST-STERILIZATION SCANNING. THE TYVEK LABEL MATCHES THE OUTER BOXING LABELS. ROOT CAUSE OF THE PROBLEM:IT IS LIKELY THE SWAP OCCURRED DURING OUTER BOXING.

    Description of Event or Problem · 0

    COMPLAINT - THE 40E DUAL MOBILITY BEARING WITH THE LOT NUMBER 2224A1124A WAS ACTUALLY A 42F DUAL MOBILITY BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680128 DJO SURGICAL EMPOWR ACETABULAR, DUAL MOBILITY, POLY BEARING, ID28, OD40 LPH ENCORE MEDICAL L.P. 2224A1124A 00190446673194

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R