UNKNOWN SHOULDER CONSTRUCT GLOBAL APG+

Description of Event or Problem

THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: RANGAN A, FLETCHER W, BICKNELL R, SMITH T; GLOBAL ICON STEMLESS SHOULDER SYSTEM MEDIUM TERM OUTCOMES: A PROSPECTIVE MULTICENTRE CLINICAL FOLLOW-UP STUDY (PUBMED CITE NOT AVAILABLE) OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFICACY AND SAFETY OF A NOVEL STEMLESS IMPLANT AT 24 MONTHS. A PROSPECTIVE MULTINATIONAL, MULTICENTER OUTCOME STUDY WAS CONDUCTED, WITH ENROLLMENT COMMENCING IN DECEMBER 2017 AND ENDING IN JULY 2019. PATIENTS BETWEEN THE AGES OF 21 AND 80 YEARS WITH SEVERELY PAINFUL AND/OR DISABLING NONINFLAMMATORY JOINT DISEASE SUITABLE FOR TOTAL SHOULDER ARTHROPLASTY WERE CONSIDERED FOR PARTICIPATION IN THE STUDY. A TOTAL OF 172 PATIENTS WERE CONSENTED FOR THE STUDY, OF WHICH 157 WENT ON TO RECEIVE THE GLOBAL ICON STEMLESS SHOULDER ARTHROPLASTY. OF THE 15 PATIENTS WHO DID NOT RECEIVE THE IMPLANT, 8 DID NOT HAVE ANY SURGERY, AND IN THE REMAINING 7, NO ATTEMPT WAS MADE TO IMPLANT THE GLOBAL ICON DEVICE. THE ¿SAFETY¿ STUDY POPULATION FOR ANALYSIS THEREFORE COMPRISED 157 PATIENTS. THE MEAN AGE OF THIS POPULATION WAS 66.0 YEARS, OF WHOM ROUGHLY HALF WERE MALE AND HALF FEMALE. FOLLOWING ROUTINE GLENOID PREPARATION, A CEMENTED GLOBAL ANCHOR PEG GLENOID COMPONENT (DEPUY SYNTHES, WARSAW, IN, USA) WAS USED IN ALL PATIENTS. MEAN FOLLOW-UP IS 24 MONTHS. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES DEVICE(S) POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: DEPUY SYNTHES GLOBAL ANCHOR PEG GLENOID COMPONENT. OTHER DEVICES THAT WERE USED ON THE PATIENT AT THE TIME OF THE EVENT: CEMENT (UNKNOWN MANUFACTURER). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS POSSIBLY ASSOCIATED WITH UNK SHOULDER CONSTRUCT GLOBAL APG+ (QTY 7): (N=1) INTRAOPERATIVE HUMERAL FRACTURE WAS NOTED INVOLVING THE METAPHYSEAL ANTERIOR WALL; NO TREATMENT REPORTED. (N=2) GLENOID FRACTURES; NO TREATMENT REPORTED. (N=1) PROXIMAL HUMERUS FRACTURE FOLLOWING TRAUMA; REVISED TO A REVERSE POLARITY .ARTHROPLASTY AT 6 MONTHS . (N=1) BURSITIS; RESPONDED TO PHYSICAL THERAPY. (N=1) SUBSCAPULARIS TEAR IN A RHEUMATOID PATIENT; RESULTED IN AN IMPLANT EXCHANGE AND REPAIR AT 8 MONTHS. (N=1) FURTHER REVISION FOR CUFF FAILURE TO REVERSE POLARITY ARTHROPLASTY OCCURRED AT 3.5 YEARS.

Additional Manufacturer Narrative

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 CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE.