BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVERSE LINER 36+0 R

    MDR report key: 19527386 · Received June 13, 2024

    Report

    Report Number
    1818910-2024-12683
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 13, 2024
    Manufacturer
    DEPUY IRELAND - 3015516266
    Product Code
    PHX
    UDI-DI
    10603295546788
    PMA / PMN Number
    K212737
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. QUANTITY OF MANUFACTURED- (B)(4). DATE OF MANUFACTURING- 2022-08-30 (PER THE LABEL CONTROL FORM) ANT ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR- I REVIEWED THE MANUFACTURING DHR¿S AND DID NOT IDENTIFY ANY ANOMALIES OR DEVIATIONS. THERE WERE SOME SCRAPPED PARTS AT THE MACHINE OPERATION DUE TO ENGRAVING NOT BEING DEEP ENOUGH AND AT THE FINISHING OPERATION DUE TO MATERIAL FINISH. THESE ARE NOT OUTSIDE OF NORMAL MANUFACTURING PRACTICE. ALL INSPECTION DOCUMENTS HAVE BEEN REVIEWED AND MEET DEFINED REQUIREMENTS. EXPIRY DATE- 2027-07-31 IFU REFERENCE- NO PHYSICAL IFU REFERENCED ON PACKAGING SPECIFICATION OUTSIDE OF WHAT WAS ON THE LABEL. 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 QUANTITY OF MANUFACTURED- (B)(4) . DATE OF MANUFACTURING- 2022-08-30 (PER THE LABEL CONTROL FORM) ANT ANOMALIES OR DEVIATIONS IDENTIFIED IN DHR- I REVIEWED THE MANUFACTURING DHR¿S AND DID NOT IDENTIFY ANY ANOMALIES OR DEVIATIONS. THERE WERE SOME SCRAPPED PARTS AT THE MACHINE OPERATION DUE TO ENGRAVING NOT BEING DEEP ENOUGH AND AT THE FINISHING OPERATION DUE TO MATERIAL FINISH. THESE ARE NOT OUTSIDE OF NORMAL MANUFACTURING PRACTICE. ALL INSPECTION DOCUMENTS HAVE BEEN REVIEWED AND MEET DEFINED REQUIREMENTS. EXPIRY DATE- 2027-07-31 IFU REFERENCE- NO PHYSICAL IFU REFERENCED ON PACKAGING SPECIFICATION OUTSIDE OF WHAT WAS ON THE LABEL. DEVICE HISTORY REVIEW A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO NON-CONFORMANCE'S / MANUFACTURING IRREGULARITIES WERE IDENTIFIED. H11 ADDITIONAL NARRATIVE: ADDED: B5 CORRECTED: D4 (PRIMARY UDI NUMBER), H8.

    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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING - A. THERE WAS NO DELAY. B. RIGHT SIDE. C. PRIMARY PROCEDURE WAS DONE ON (B)(6) 2024. D. THE FIRST WASH OUT WAS ON (B)(6) 2024-THIS PATIENT DID HAVE A WASHOUT/ REVISION ON (B)(6) 2024 DUE TO AN INFECTION, AND NOTHING TO DO WITH THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS WASHED OUT FOR A 2ND TIME FOR AN INFECTION SHE ACQUIRED AFTER SURGERY. THE SURGEON DECIDED DURING THIS WASH OUT TO EXCHANGE THE GLENOSPHERE FOR A +8 DUE TO INSTABILITY HE NOTICED DURING THIS 2ND WASHOUT, AS WELL AS HE DECIDED TO SWAP OUT THE POLY FOR A THICKER ONE. THIS REVISION WAS DUE TO AN INFECTION, AND NOT DUE TO PRODUCT MALFUNCTION. THERE WAS NO DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185316 REVERSE LINER 36+0 R SHOULDER IMPLANT - HUMERAL CUP PHX DEPUY IRELAND - 3015516266 MI152931 10603295546788

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention GLENOSPHERE 36+4.