| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-11-07 | 0 | 1. H; 2. R |
Patient 1
ZIMMER BIOMET COMPLAINT (B)(4). THE EVENT OCCURRED SOMETIME IN (B)(6) 2019. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS IT IS STILL IMPLANTED. THE INVESTIGATION IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Patient 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SHARP PAIN IN HIS LOWER BACK. THE PAIN INTENSIFIED AND THE PATIENT WAS UNABLE TO MOVE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THREE DAYS. THE DOCTORS AT THE HOSPITAL TOLD THE PATIENT THAT IT WAS A SEVERE MUSCLE SPASM. THE PATIENT WAS GIVEN PAIN MEDICATION. THE PATIENT WAS PRESCRIBED MEDICATIONS UPON RELEASE. THE PATIENT HAS FOLLOWED UP WITH HIS GENERAL PRACTITIONER AND STATES THAT HE IS IN GOOD HEALTH AND HAS NOT HAD ANY PROBLEMS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.