Arthrex® AR-502-4RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867034679), received between Sep 25, 2024 and Sep 25, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  ON 08/26/2024, IT WAS REPORTED BY A PATIENT VIA PHONE THAT THE PATIENT HAD SURGERY ON (B)(6) 2018 FOR A RIGHT KNEE PATELLOFEMORAL JOINT REPLACEMENT. AFTER THE SURGERY, THE PATIENT EXPERIENCED PAIN WHEN LYING DOWN AND LATER ON EXPERIENCED SHARP PAIN IN THE BACK OF THE LEG WHEN GOING UP THE STAIRS WITH THE PATIENT'S LEG GIVING OUT. AN X-RAY WAS PERFORMED AFTERWARD AND SHOWED THAT THE UNKNOWN ARTHREX PART NUMBER THAT WAS IMPLANTED ON (B)(6) 2018 HAD COME APART/BROKEN. PER THE PATIENT, THE SURGEON STATED THIS WAS NOT NORMAL AND PERFORMED AN ARTHROPLASTY TOTAL REVISION SURGERY ON THE RIGHT KNEE ON (B)(6) 2024 TO REMOVE THE BROKEN PART AND PUT A NEW PART IN. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEON AT DIFFERENT FACILITIES. ADDITIONAL INFORMATION RECEIVED ON 9/5/2024: THE MEDICAL RECORDS INDICATE THAT THE PATIENT DID WELL FOLLOWING HIS 2018 SURGERY UNTIL HE FIRST EXPERIENCED RIGHT POSTERIOR KNEE PAIN ABOUT A YEAR AGO. THE PATIENT REPORTED THAT THERE WAS NO PRECEDING INJURY OR TRAUMA. THE PATIENT BELIEVES THE PAIN BEGAN SHORTLY AFTER RECEIVING STEM CELL INJECTIONS ON THE RIGHT FOOT. THE PATIENT'S SYMPTOMS WORSENED ON (B)(6) 2024 THE PATIENT EXPERIENCED SHARP PAIN IN THE BACK OF TH

  Patient problems: Failure of Implant; Implant Pain; Joint effusion; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 20299961 ↗