DJO SURGICAL

Description of Event or Problem

REVISION SURGERY - IMPLANTS DID NOT FAIL. PATIENT WAS JUST IN PAIN AND NEEDED TO BE CONVERTED TO REVERSE, DUE TO FAILED CUFF.

Additional Manufacturer Narrative

THE AGENT REPORTED "(IMPLANTS DID NOT FAIL. PATIENT WAS JUST IN PAIN AND NEEDED TO BE CONVERTED TO REVERSE, DUE TO FAILED CUFF)". THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 2 YEARS AND 11 MONTHS APART. ITEM NUMBER: 520-08-021, ITEM DESCRIPTION: ALTIVATE ANATOMIC CS, HUMERAL STEM AND NECK KIT, SIZE 2, LOT NUMBER: 1924A1254, PART REVISION: B, PRODUCT TYPE: SHOULDER, MANUFACTURE DATE: 10/04/2022, EXPIRATION DATE: 09/28/2027. THIS EVALUATION IS LIMITED IN SCOPE AS THE ITEMS ASSOCIATED WITH THIS INVESTIGATION WERE NOT RETURNED TO DJO SURGICAL - AUSTIN FOR REVIEW. THE SURGERY WAS COMPLETED AS INTENDED AND WITHOUT INCIDENT. IF ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT 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 DEFECTIVE. THE SURGEON PERFORMED THIS PROCEDURE TO REMEDY THE PATIENT'S CONDITION. NO FURTHER ACTION IS DEEMED NECESSARY. ROOT CAUSE: THE ROOT CAUSE OF THIS COMPLAINT WAS A REVISION SURGERY DUE TO PAIN AND FAILED CUFF. 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 EVENT. THERE ARE MULTIPLE FACTORS THAT MAY ALSO CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE THE CONTROL OF DJO SURGICAL SUCH AS POOR BONE DENSITY, PATIENT BONE DETERIORATION, PROLONGED OVERHEAD ACTIVITIES, INADEQUATE SOFT TISSUE SUPPORT, PATIENT ACTIVITIES OR TRAUMA. 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.