UNKNOWN STEM

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CLUNKING SENSATION WHILE WALKING FIVE DAYS POSTOPERATIVELY FOLLOWING THE ORIGINAL SURGERY. X-RAYS WERE OBTAINED, AND NO DISLOCATION WAS IDENTIFIED. THE PATIENT LATER REPORTED JOINT PAIN AND PRESENTED TO THE EMERGENCY ROOM (ER). THE ER TREATED THE PATIENT FOR KNEE PAIN AND DID NOT EVALUATE THE HIP. AT THE SIX-WEEK FOLLOW-UP WITH THE SURGEON, THE PATIENT CONTINUED TO COMPLAIN OF CLUNKING AND PAIN. ADDITIONAL X-RAYS DID NOT REVEAL A DISLOCATION. AS THE PATIENT¿S PAIN PERSISTED, THEY WERE REFERRED TO A PAIN SPECIALIST, WHERE A CT SCAN OF THE HIP IDENTIFIED A DISLOCATION. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 3 MONTHS POST-IMPLANTATION TO CORRECT THE DISLOCATION. DURING THE PROCEDURE, THE SURGEON FOUND THAT THE STEM WAS COMPLETELY LOOSE. THE STEM SPUN FREELY AND WAS ABLE TO BE REMOVED BY HAND. THE SURGEON CEMENTED THE SAME STEM BACK INTO THE PATIENT. THE ORIGINAL 46 MM G7 CUP WAS RETAINED, AND A CONSTRAINED LINER WAS IMPLANTED. FOLLOWING THE REVISION SURGERY, THE PATIENT RETURNED TO NORMAL FUNCTION, WAS SATISFIED WITH THE OUTCOME, AND HAS NOT EXPERIENCED ANY ADDITIONAL DISLOCATION EVENTS. FOLLOW-UPS TO GATHER ADDITIONAL INFORMATION ARE CURRENTLY IN PROCESS.

Additional Manufacturer Narrative

(B)(4). D10: UNKNOWN HEAD. UNKNOWN LINER. PROPOSED COMPONENT CODE: MECHANICAL (G04) - STEM. THE CUSTOMER INDICATED THAT THE PRODUCT REMAINS IMPLANTED; THEREFORE, IT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL MDR WILL BE SUBMITTED.