DELTA XTEND

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

PATIENT UNDERWENT EXTERNAL SURGERY AT THE BEGINNING OF 2024. THERE WAS A MISALIGNMENT OF THE GLENOSPHERE (SUPERIOR TILT). PATIENT PRESENTED TO DOCTOR BECAUSE OF PAIN. GLENOSPHERIC SCREW WAS PROBABLY BROKEN DISTALLY. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY. PATIENT HAD PREVIOUS GLENOSPHERE PLUS INLAY CHANGE DUE TO INCORRECT POSITION FROM OUTSIDE.