BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK SHOULDER GLENOSPHERE DELTA XTEND

    MDR report key: 19644535 · Received July 1, 2024

    Report

    Report Number
    1818910-2024-14366
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    September 15, 2023
    Report Date
    July 1, 2024
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    KWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: THE DEVICE CATALOG NUMBER IS UNKNOWN; THEREFORE, UDI IS UNAVAILABLE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TORRENS C, MARÍ R, PUIG-VERDIER L, SANTANA F, ALIER A, GARCÍA-JARABO E, GÓMEZ-SÁNCHEZ A, CORVEC S. FUNCTIONAL OUTCOMES AND COMPLICATIONS OF PATIENTS CONTAMINATED WITH CUTIBACTERIUM ACNES DURING PRIMARY REVERSE SHOULDER ARTHROPLASTY: STUDY AT TWO- AND FIVE-YEARS OF FOLLOW-UP. INT ORTHOP. 2023 NOV;47(11):2827-2833. DOI: 10.1007/S00264-023-05971-Y. EPUB 2023 SEP 15. PMID: 37710071. 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.

    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. 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 : 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.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: TORRENS C, MARÍ R, PUIG-VERDIER L, SANTANA F, ALIER A, GARCÍA-JARABO E, GÓMEZ-SÁNCHEZ A, CORVEC S. FUNCTIONAL OUTCOMES AND COMPLICATIONS OF PATIENTS CONTAMINATED WITH CUTIBACTERIUM ACNES DURING PRIMARY REVERSE SHOULDER ARTHROPLASTY: STUDY AT TWO- AND FIVE-YEARS OF FOLLOW-UP. INT ORTHOP. 2023 NOV;47(11):2827-2833. DOI: 10.1007/S00264-023-05971-Y. EPUB 2023 SEP 15. PMID: 37710071. OBJECTIVE/METHODS/STUDY DATA: PURPOSE: THE OBJECTIVE OF THE STUDY WAS TO COMPARE THE FUNCTIONAL OUTCOMES AND THE COMPLICATION RATE OF THE PATIENTS WITH C. ACNES CONTAMINATION AT THE END OF THE PRIMARY REVERSE SHOULDER ARTHROPLASTY (RSA) SURGERY TO THOSE PATIENTS WITHOUT C. ACNES CONTAMINATION. METHOD: A TOTAL OF 162 PATIENTS WERE INCLUDED. IN ALL CASES, SKIN AND DEEP TISSUE CULTURES WERE OBTAINED. A MOLECULAR TYPING CHARACTERIZATION OF THE C. ACNES STRAINS WAS PERFORMED. FUNCTIONAL OUTCOMES WERE ASSESSED WITH THE CONSTANT SCORE AT THE TWO- AND FIVE-YEAR FOLLOW-UP AND ALL COMPLICATIONS WERE ALSO RECORDED. RESULTS: A TOTAL OF 1380 CULTURES WERE OBTAINED FROM THE 162 PRIMARY RSA SURGERIES. OF THOSE, 96 TURNED OUT TO BE POSITIVE FOR C. ACNES. THERE WERE 25 PATIENTS WITH POSITIVE CULTURES FOR C. ACNES. THE OVERALL POSTOPERATIVE CONSTANT SCORE WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN THOSE PATIENTS HAVING C. ACNES-POSITIVE CULTURES AND THOSE WITH NEGATIVE CULTURES AT THE TWO- AND FIVE-YEAR FOLLOW-UP (59.2 VS. 59.6 AT TWO YEARS, P 0.870, AND 59.5 VS. 62.4 AT FIVE YEARS, P 0.360). PATIENTS WITH POSITIVE CULTURES PRESENTED A HIGHER COMPLICATION RATE (P 0.001) WITH TWO INFECTIONS, ONE REVISION SURGERY, AND ONE DISLOCATION. CONCLUSION: PATIENTS ENDING UP WITH C. ACNES-POSITIVE CULTURES AFTER PRIMARY SHOULDER ARTHROPLASTY SURGERY DO NOT HAVE WORSE CLINICAL OUTCOMES WHEN COMPARED TO PATIENTS HAVING NEGATIVE CULTURES, BUT A GREATER NUMBER OF COMPLICATIONS WERE FOUND IN THOSE PATIENTS WITH C. ACNES-POSITIVE CULTURES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: UNK SHOULDER HUMERAL STEM DELTA XTEND, UNK SHOULDER HUMERAL CUP DELTA XTEND, UNK SHOULDER GLENOSPHERE DELTA XTEND, UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND, UNK SHOULDER METAGLENE, UNK SHOULDER LOCKING SCREW (MINIMUM OF 2). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL STEM DELTA XTEND: QTY 2 DEFINITE INFECTIONS TREATED WITH REVISION SURGERY QTY 1 UNEXPLAINED PAIN TREATED WITH REVISION SURGERY ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND: QTY 2 DEFINITE INFECTIONS TREATED WITH REVISION SURGERY QTY 1 UNEXPLAINED PAIN TREATED WITH REVISION SURGERY ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER HUMERAL CUP DELTA XTEND: QTY 2 DEFINITE INFECTIONS TREATED WITH REVISION SURGERY QTY 1 UNEXPLAINED PAIN TREATED WITH REVISION SURGERY QTY 1 JOINT DISLOCATION TREATED WITH REVISION SURGERY ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER GLENOSPHERE DELTA XTEND: QTY 2 DEFINITE INFECTIONS TREATED WITH REVISION SURGERY QTY 1 UNEXPLAINED PAIN TREATED WITH REVISION SURGERY QTY 1 JOINT DISLOCATION TREATED WITH REVISION SURGERY ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER METAGLENE: QTY 2 DEFINITE INFECTIONS TREATED WITH REVISION SURGERY QTY 1 UNEXPLAINED PAIN TREATED WITH REVISION SURGERY ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER LOCKING SCREW: QTY 2 DEFINITE INFECTIONS TREATED WITH REVISION SURGERY QTY 1 UNEXPLAINED PAIN TREATED WITH REVISION SURGERY ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER LOCKING SCREW: QTY 2 DEFINITE INFECTIONS TREATED WITH REVISION SURGERY QTY 1 UNEXPLAINED PAIN TREATED WITH REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270973 UNK SHOULDER GLENOSPHERE DELTA XTEND SHOULDER GLENOSPHERE KWS DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention