DJO SURGICAL

Additional Manufacturer Narrative

THE AGENT REPORTED, "PATIENT WITH FAILED ANATOMIC. REMOVED STEMLESS ANATOMIC & GLENOID AND REVISED TO A REVERSE. FEMALE 62." THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 1 YEAR, 6 MONTHS, 20 DAYS APART. ITEM NUMBER: 521-07-242, "ITEM DESCRIPTION: ALTIVATE ANATOMIC, ALL-POLY PEGGED GLENOID, SIZE 42, E-PLUS", LOT#: 891U1339, PART REVISION: B, PRODUCT TYPE: SHOULDER, MANUFACTURE DATE: 03-APR-2024, EXPIRATION DATE: 27-MAR-2029. THIS EVALUATION IS LIMITED IN SCOPE AS THE ITEM(S) ASSOCIATED WITH THIS INVESTIGATION WAS NOT RETURNED TO DJO SURGICAL - AUSTIN FOR EXAMINATION. THE SURGERY WAS COMPLETED AS INTENDED. 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 THAT THE REPORTED DEVICE(S) WAS 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 A FAILED ANATOMIC SHOULDER, DURING WHICH THE STEMLESS ANATOMIC IMPLANT AND GLENOID WERE REMOVED AND CONVERTED TO A REVERSE SYSTEM. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN EVENT THAT ARE OUTSIDE OF THE CONTROL OF ENOVIS 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 WAS A NONCONFORMING MATERIAL REPORT (NCMR#72798) ASSOCIATED WITH THE CONCOMITANT PART 520-42-216, WHICH DOCUMENTED THAT OUT OF 166 PARTS IN THE LOT, 5 PARTS WERE REJECTED DUE TO SCRATCHES, DENTS, DINGS, AND OTHER VISUAL NONCONFORMANCE'S. THE REJECTED PARTS WERE SCRAPPED OR REWORKED AS APPROPRIATE, WITH 62 PARTS REWORKED AND ACCEPTED AFTER PROPER JUSTIFICATION, AND NO RTV REQUIRED. ALL OTHER ITEMS IN THE LOT MET FIT, FORM, AND FUNCTION REQUIREMENTS. THE DEVICES WERE VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WERE WITHIN THEIR EXPIRATION DATE AT THE TIME OF THE PREVIOUS SURGERY. COMPLAINT HISTORY: CUSTOMER COMPLAINT HISTORY OF THE REPORTED DEVICE(S) SHOWED NO PRESENT TRENDS OR ONGOING ISSUES THAT NEED REVIEW.

Description of Event or Problem

REVISION SURGERY DUE TO IMPLANT FAILURE.