SMARTSET

Description of Event or Problem

ON (B)(6) 2016, THE PATIENT RECEIVED A DEPUY REVISION KNEE SYSTEM IMPLANT IN THE RIGHT KNEE. THE COMPONENTS INCLUDED A SIGMA 5 FEMORAL SIZE 1 AND A METAPHYSEAL SLEEVE SIZE 4, TC3 TYPE. IN (B)(6) 2025, X-RAYS REVEALED LOOSENING OF THE TC3 COMPONENT AND BROKEN SCREWS. ON (B)(6) 2026, THE PATIENT UNDERWENT A KNEE REVISION SURGERY DUE TO THE PREMATURE FAILURE OF THE DEPUY SIGMA TC3 COMPONENT. RELIEF IS SOUGHT FOR PAIN AND SUFFERING RESULTING FROM THE DEVICE FAILURE, THE LATENT DEFECT, AND THE SUBSEQUENT NEED FOR REVISION SURGERY. DOI: (B)(6) 2016. DOR: (B)(6) 2026. AFFECTED SIDE: RIGHT KNEE.

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.