Arthrex® AR-611-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867240346), received between Feb 11, 2021 and Apr 30, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Break

  ON 14-APR-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-611-7 TIBIAL TRIALING SHIM BROKE OFF ON ONE SIDE DURING A CASE. NOTICED DURING A CASE BUT ABLE TO BE COMPLETED WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25045803 ↗
• MalfunctionFeb 9, 2026Break

  ON 19-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-611-7 IBAL UKA TIBIA TRIALING SHIM BROKE UPON INSERTION. THIS WAS DISCOVERED DURING A UKA, AND THE CASE WAS COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291616 ↗
• MalfunctionSep 25, 2024Break; Break

  ON 09/18/2024, A SALES REPRESENTATIVE REPORTED VIA SEMS-(B)(4) THAT AN AR-611-7 IBALANCE UKA TIBIAL TRIALING SHIM WAS BROKEN WHILE TESTING THE LEG IN FLEXION. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WAS NO CASE DELAY. THE CASE WAS COMPLETED WITH THE SURGEON TENSIONING THE KNEE WITH "FEEL" INSTEAD OF A 2MM STICK. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING A UKA PROCEDURE ON (B)(6) 2024, WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20303539 ↗
• MalfunctionFeb 11, 2021Break

  IT WAS REPORTED THAT THE AR-611-7 TRIALING SHIM IS DAMAGED. ADDITIONAL INFORMATION RECEIVED ON 1/27/2021: THE REP REPORTED THE DEVICE BROKE DURING THE FINAL INSERTION FOR CEMENT HARDENING PHASE. THE DEVICE BROKE ON INSERTION INTO THE KNEE. ALL BROKEN FRAGMENTS WERE FULLY RETRIEVED AND ACCOUNTED FOR. NO UNPLANNED INCISIONS WERE NECESSARY. THE CASE WAS COMPLETED BY USING VALGUS FORCE TO PROVIDE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314109 ↗