UNKNOWN DEPUY ASR FEMORAL HEAD

Additional Manufacturer Narrative

IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: UNAVAILABLE. THIS COMPLAINT IS THE SUBJECT OF LITIGATION OR A LEGAL CLAIM AND CURRENTLY COMPLETE PRODUCT DETAIL IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

SALES REP REPORTED REVISION SURGERY. PATIENT HAS BEEN REVISED AT THEIR REQUEST. NO SYMPTOMS REPORTED. X-RAYS APPEARED TO REPRESENT WELL-FIXATED COMPONENTS. UPDATE REC¿D 08/11/2014 - LEGAL CLAIM WAS RECEIVED, WHICH IDENTIFIED DOB INFORMATION. THERE WAS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. THE COMPLAINT WAS UPDATED ON: 09/09/2014. UPDATE REC'D 11/26/2014- LITIGATION PAPERS RECEIVED. LITIGATION ALLEGES PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, LOSS OF ENERGY, IMMOBILIZATION AND BOTH ACUTE LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUNDING THE ACETABULUM AND SYSTEMIC INJURIES, AND ELEVATED METAL ION LEVELS. THE STEM AND SLEEVE ARE BEING ADDED. THE EXISTING MDR DECISION HAS BEEN REVERSED AND CUP AND HEAD ARE BEING REPORTED. THE COMPLAINT WAS UPDATED ON: 12/18/2014.