DJO SURGICAL

Additional Manufacturer Narrative

THE AGENT REPORTED "POLY WEAR/INSTABILITY. FEMALE 69." THE PREVIOUS SURGERY AND THE SURGERY DETAILED IN THIS EVENT OCCURRED 5 YEARS, 6 MONTHS, 5 DAYS APART. ITEM NUMBER: 509-02-032, ITEM DESCRIPTION: AR, SMALL SOCKET INSERT, 32MM NEUTRAL EPLUS, LOT#: 951W1526, PART REVISION: B, PRODUCT TYPE: SHOULDER, MANUFACTURE DATE: 08-OCT-2020, EXPIRATION DATE: 28-SEP-2025. 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 POLY WEAR. 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 RECORD(S) SHOWS THAT THE REPORTED COMPONENT(S) USED IN THE PREVIOUS SURGERY MET DESIGN AND MANUFACTURING REQUIREMENTS AT THE TIME OF RELEASE FOR USE. THERE WERE NO NONCONFORMING MATERIAL REPORTS ASSOCIATED WITH THE PRODUCT(S) THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE(S) WAS VERIFIED TO HAVE GONE THROUGH AN ACCEPTABLE STERILIZATION PROCESS AND WAS WITHIN ITS 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 WEAR/INSTABILITY.