AML EXCEL
Received Jun 1, 2026 · Event occurred Mar 23, 2026
Report 1818910-2026-09483 · MDR key 25349006
Device
Generic name
Hip Instruments : Cutting Instruments
Manufacturer
Depuy Orthopaedics Inc UsCatalog number
200148000
Lot number
AY1097J
Product problems
- Failure to Cut
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 (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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. 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 SURGEON SAID THAT THE CALCAR PLANAR WAS DULL AND DID NOT CUT BONE. THEY ASKED IT TO BE REMOVED FROM THE HOSPITAL AND REPLACED. THERE WAS NO NEGATIVE OUTCOMES AND NO ISSUES TO PATIENT. THERE WAS NO ISSUES TO SURGEON AND NO DELAY OF SURGERY.