Arthrex® AR-611-6Recalls & reported problems
Arthrex, Inc. · iBal UKA, Femoral Impactor · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867223875), received between Feb 1, 2021 and Jan 26, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Break” (12 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.
Reports received per month
Most reported problems
Device problems
- Break12
- Crack2
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information4
- Foreign Body In Patient1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 26, 2026Break
ON 09-JAN-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-611-6 IBAL UKA FEMORAL IMPACTOR TIP BROKE OFF. THIS WAS DISCOVERED DURING THE CASE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24177771 ↗MalfunctionJan 17, 2025Break; Break
ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-611-6 FEMORAL IMPACTORS PLASTIC TIP WAS BROKEN. THIS OCCURRED DURING A CASE WITH ALL FRAGMENTS RETRIEVED. THERE WERE NO ADVERSE EVENTS OR PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21182505 ↗MalfunctionSep 4, 2024Break; Break
ON 08/06/2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS (B)(4) THAT AN AR-611-6 FEMORAL IMPACTOR TIP OF THE DEVICE THAT CONNECTS TO FEMUR BROKE OFF WHILE BEING HAMMERED. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20135177 ↗MalfunctionJun 13, 2024Break; Break
IT WAS REPORTED THAT THE AR-611-6 IMPACTOR IS CRACKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19531410 ↗MalfunctionJun 7, 2024Break; Break
IT WAS REPORTED THAT THE AR-611-6, CRACKED WHILE IMPLANTING FEMORAL COMPONENT WITH MALLET. IMPLANT WAS SUCCESSFULLY IMPLANTED. NO HARM WAS CAUSED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19483968 ↗MalfunctionJun 4, 2024Crack; Crack
IT WAS REPORTED THAT THE FOLLOWING AS CRACKED: AR-611-6. AR-611-SM05. AR-611-SM10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19463615 ↗MalfunctionMay 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 10/27/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-611-6 FEMORAL IMPACTOR SPLIT IN HALF AND AN AR-601-BBS0 TIBIAL TRIALING SHIM ALSO BROKE IN HALF. THIS WAS DISCOVERED DURING A CASE.
Patient problems: Insufficient Information
MAUDE report 19332849 ↗MalfunctionFeb 29, 2024Crack; Crack
ON 02/12/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN IBAL UKA FEMORAL IMPACTOR, AR-611-6, IS CRACKED ON THE END. OCCURRED DURING A CASE, NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18806666 ↗MalfunctionDec 21, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-611-6 IBAL UKA, FEMORAL IMPACTOR PLASTIC TIP WAS BROKEN DURING IMPACTION. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE ON (B)(6) 2023, WITH NO REPORTED PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18378078 ↗MalfunctionJun 21, 2023Break; Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-611-6 FEMORAL IMPACTOR BROKE. THIS OCCURRED DURING A CASE WHILE IMPACTING IT.
Patient problems: Insufficient Information
MAUDE report 17170701 ↗MalfunctionFeb 23, 2023Break
ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-611-6 FEMORAL IMPACTORS TIP BROKE OFF. THIS OCCURRED DURING A UNI KNEE CASE ON (B)(6) 2023 WHILE USING THE IMPACTOR THE GRAY TIP BROKE OFF. ALL PIECES WERE RETRIEVED, AND THE CASE WAS FINISHED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. ADDITIONAL INFORMATION REQUESTED.
Patient problems: Foreign Body In Patient; Insufficient Information
MAUDE report 16427691 ↗MalfunctionAug 18, 2022Break
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-611-6 IBAL UKA, FEMORAL IMPACTOR BROKE DURING THE CASE ON (B)(6) 2022. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15250111 ↗MalfunctionDec 7, 2021Break
ON 11/18/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT AN AR-611-6 AND AR-611-4, BOTH UNI KNEE IMPACTORS BROKE AND SHATTERED DURING THE NORMAL COURSE OF SURGERY. THIS WAS DISCOVERED DURING USE IN A UNI KNEE PROCEDURE ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW IMPACTOR.
Patient problems: Insufficient Information
MAUDE report 12953690 ↗MalfunctionFeb 22, 2021Break
IT WAS REPORTED DURING A UNI KNEE ARTHROPLASTY THE AR-611-6 FEMORAL IMPACTOR BROKE WHILE IMPLANTING THE FEMORAL IMPLANT. THERE WAS NO PATIENT HARM AND ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11357792 ↗MalfunctionFeb 1, 2021Break
IT WAS REPORTED THAT DURING A UNI-KNEE ARTHROPLASTY, THE IMPACTOR BROKE IN HALF WHEN THE SURGEON WAS IMPACTING THE FEMORAL IMPLANT. NONE OF THE BROKEN PIECES WENT INTO THE PATIENT; THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11259318 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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