EQUINOXE STEMLESS SHOULDER COMPONENTS

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. APPROXIMATELY 25 MONTHS POST-OP, THE PATIENT EXPERIENCED SUB-ACROMIAL IMPINGEMENT WITH PAIN AND RECEIVED A SUBACROMIAL INJECTION. THE ISSUE HAD RESOLVED AT 28 MONTHS POST-OP. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

D10: 300-60-02 - STEMLESS HUMERAL COMP LASER CAGE, SIZE 2: A237330. 310-62-47 - STEMLESS HUMERAL HEAD 47MM X 15MM X BETA: A379306. 314-24-33 - LASER CAGE GLENOID M, 8 POST AUG, RIGHT: A448551. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED UPDATED: H6. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE RESULTED FROM AN UNDERLYING PATIENT CONDITION, INFECTION, COMPONENT LOOSENING, COMPONENT SIZING, POSITIONING, OR IMPINGEMENT ISSUES, OR A COMBINATION OF THE ABOVE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.