EDGE AES-50SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20653405988332), received between May 18, 2023 and Apr 15, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE AES-50SP, AES-50SP EDGE HIP PROBE 50 DEGREE WAS BEING USED DURING A HIP ARTHROSCOPY PROCEDURE ON (B)(6) 2024 DATE WHEN IT WAS REPORTED ¿THE HEAD OF THE PROBE FELL OFF AFTER JUST USING THE PROBE". THE FRAGMENT WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19103954 ↗
• MalfunctionMay 25, 2023Material Fragmentation; Material Fragmentation

  THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF A MEDWATCH REPORT (MW5117479) RECEIVED ON (B)(6) 2023. A SEARCH OF THE COMPLAINT SYSTEM HAS NOT FOUND A COMPLAINT REPORTED FOR THIS DEVICE/LOT NUMBER DURING THIS TIMEFRAME. THE REPORT WAS FOUND TO BE WRITTEN AGAINST THE AES-50SP PARADIGM EDGE HIP PROBE. THE REPORT STATES THAT ON (B)(6) 2023 ¿WHILE USING PARADIGM HIP PROBE, A PIECE BECAME DISLODGED FROM PROBE AND HAD TO BE REMOVED. RETRIEVAL OF THE FOREIGN BODY CAUSED A 1 HOUR DELAY.¿. THERE WAS INJURY OR IMPACT TO THE PATIENT OR USER. FURTHER ASSESSMENT COULD NOT BE SENT AS THE REPORTER DID NOT IDENTIFY HIMSELF/HERSELF, OR THE FACILITY WHERE THE EVENT OCCURRED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001589 ↗
• InjuryMay 18, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE WAS BEING USED ON (B)(6) 2023 DURING A HIP ARTHROSCOPY PROCEDURE AND ¿CIRCULAR METAL FACE OF THE PROBE FELL OFF FROM THE HANDPIECE AND INTO THE JOINT. IT TOOK 2 HOURS TO TRY AND GET IT OUT OF THE JOINT. CAUSED A MAJOR DELAY IN SURGERY BUT NO PATIENT HARM. PATIENT INJURY? NO, BIGGER INCISION THOUGH.¿. THE PROCEDURE WAS COMPLETED. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THE FRAGMENT WAS RETRIEVED. THERE WAS NO EXTENDED STAY AT THE HOSPITAL FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF A LARGER INCISION WAS NEEDED TO RETRIEVE THE FRAGMENTS FROM THE PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952700 ↗