DJO SURGICAL

Additional Manufacturer Narrative

SEE D4 EXPIRATION DATE, H4, H6, AND H11. THE AGENT REPORTED "(INFECTION)". THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 14 DAYS APART. ITEM NUMBER: 520-08-021, ITEM DESCRIPTION: ALTIVATE ANATOMIC CS, HUMERAL STEM AND NECK KIT, SIZE 2, LOT NUMBER: 1924A1547, PART REVISION: B, PRODUCT TYPE: SHOULDER, MANUFACTURE DATE: 10/20/25, EXPIRATION DATE: 10/09/30. THIS EVALUATION IS LIMITED IN SCOPE AS LIMITED INFORMATION WAS PROVIDED TO DJO SURGICAL - AUSTIN FOR REVIEW. IF INFORMATION REGARDING CULTURES IDENTIFIED IN THE INFECTION, THE SEVERITY OF THE INFECTION OR ANY OTHER RELEVANT INFORMATION IS SUBMITTED AT A FUTURE DATE, THIS INVESTIGATION WILL BE RE-EVALUATED. THERE WAS NO INFORMATION SUBMITTED WITH THIS COMPLAINT ABOUT ANY PATIENT ACTIVITIES, ACCIDENTS, OR MEDICAL CONTRAINDICATIONS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO FINDINGS DURING THIS EVALUATION THAT INDICATE THE REPORTED DEVICES WERE THE SOURCE OR HAD A DIRECT CONNECTION WITH THE PATIENT'S INFECTION. ROOT CAUSE: THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO AN INFECTION. NO INFORMATION WAS SUBMITTED WITH THE COMPLAINT REGARDING PRE-EXISTING CONDITIONS OF THE PATIENT OR ANY ACTIVITIES THE PATIENT WAS INVOLVED IN THAT MAY HAVE CONTRIBUTED TO THE POSSIBLE INFECTION OR INHIBITED THE PATIENT'S IMMUNE SYSTEM. DUE TO THE SHORT TIME BETWEEN THE ORIGINAL SURGERY AND THE REVISION, IT IS POSSIBLE THAT THE INFECTION WAS ACQUIRED IN THE HOSPITAL (NOSOCOMIAL). IT IS ALSO POSSIBLE THAT THE PATIENT WAS NOT COMPLIANT WITH POST-SURGICAL INSTRUCTIONS. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE OF THE CONTROL OF DJO SURGICAL. CONTAINMENT: INVENTORY CONTAINMENT IS NOT REQUIRED AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. DEVICE HISTORY RECORDS REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) SHOW THAT THE REPORTED COMPONENTS USED IN THE PREVIOUS SURGERY, WHEN RELEASED FOR USE, MET DESIGN AND MANUFACTURING REQUIREMENTS. THERE WERE NO NON-CONFORMING MATERIAL REPORTS (NCMR) ASSOCIATED WITH THE PRODUCTS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICES WERE VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WERE WITHIN ITS EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. COMPLAINT HISTORY: CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICES SHOWED NO PRESENT TRENDS OR ON-GOING ISSUES THAT ARE NEEDING A REVIEW.

Description of Event or Problem

INFECTION.M/62.

Additional Manufacturer Narrative

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