SIGMA LCS
Received Jul 13, 2026 · Event occurred Jun 4, 2026
Report 1818910-2026-11832 · MDR key 25794682
Device
Generic name
Knee Instrument : Alignment Devices
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
950501203
Product problems
- Break
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE INSTRUMENT NO LONGER WORKED PROPERLY. ACCORDING TO THE REPORT, THERE SEEMED TO HAVE BEEN A LOCK FRACTURE. THE NUMBER OF DEGREES COULD BE SET BUT KEPT SHIFTING, AND NO LONGER REMAINED. IT WAS CONFIRMED THAT THE DEVICE DID NOT BREAK INTO TWO OR MORE PIECES. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.