DJO SURGICAL

Description of Event or Problem

REVISION SURGERY - DUE TO POLY WEAR.

Additional Manufacturer Narrative

IT WAS REPORTED AS, REVISION SURGERY: "CUFF FAILURE AND POLY WEAR - CONVERTED TO REVERSE" THE ACTUAL LENGTH OF IN-VIVO FOR THE ITEM LISTED IS UNKNOWN AS THE ORIGINAL SURGERY DATE WAS NOT PROVIDED OR COULD BE ESTABLISHED. ITEM NUMBER: UNK-SURG, ITEM DESCRIPTION: UNKNOWN PART FOR SURGICAL, LOT NUMBER: UNKNOWN, PART REVISION: NA, PRODUCT TYPE: SHOULDER, MANUFACTURE DATE: UNKNOWN, EXPIRATION DATE: UNKNOWN. THIS INVESTIGATION IS LIMITED IN SCOPE AS ONLY PARTIAL INFORMATION WAS PROVIDED TO DJO SURGICAL - AUSTIN FOR REVIEW. THE REVISED ITEM WAS NOT RETURNED FOR EXAMINATION AND THE ITEM AND OR LOT NUMBER WAS NOT PROVIDED. TO ADEQUATELY INVESTIGATE THIS EVENT, THE PART AND LOT NUMBERS ARE NECESSARY. IF THIS 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. THE SURGEON PERFORMED THIS REVISION TO REMEDY THE PATIENT'S CONDITION. THIS COMPLAINT WILL BE CLOSED PENDING RECEIPT OF ADDITIONAL INFORMATION. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME.