DJO SURGICAL

Description of Event or Problem

REVISION SURGERY - DUE TO LOOSE COMPONENT.

Additional Manufacturer Narrative

IT WAS REPORTED AS REVISION SURGERY: "LOOSE COMPONENT. FEMALE 65." THE ACTUAL IN-VIVO LENGTH FOR THE LISTED ITEM IS UNKNOWN, AS THE ORIGINAL SURGERY DATE WAS NOT PROVIDED OR COULD NOT BE ESTABLISHED. NOTE: PATIENT IS BILATERAL, PRIOR SURGERIES PERFORMED SEPARATELY. PRIOR DTICKETS UNMARKED FOR SURGERY SIDE. PROVIDED BOTH DTICKETS (ATTACHED). REP WAS UNSURE WHICH ITEMS WERE REMOVED FROM LEFT SIDE REVISION TO REVERSE. ITEM NUMBER: UNKNOWN. ITEM DESCRIPTION: UNKNOWN. LOT NUMBER: UNKNOWN. PART REVISION: NA. PRODUCT TYPE: SHOULDER. MANUFACTURE 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 WERE 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. NO INFORMATION WAS SUBMITTED WITH THIS COMPLAINT REGARDING 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.