Arthrex® AR-516-4RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867109339), received between Apr 4, 2017 and Jun 6, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (2 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.

• MalfunctionJun 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 5/13/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT A PATIENT WHO UNDERWENT AN IBALANCE PROCEDURE HAS EXPERIENCED LOOSE IMPLANTS POST-SURGERY. DURING THE INITIAL SURGERY, AN AR-516-4R IBALANCE CEMENTED TKA FEMORAL IMPLANT PS, AN AR-503-TTTG IBALANCE CEMENTED TKA TIBIAL TRAY IMPLANT, AN AR-504-PSC9 IBALANCE DOMETKA PATELLA IMPLANT, AND AN AR-513-BG13 IBALANCE PS TKA TIBIAL BEARING IMPLANT WERE USED. ADDITIONAL INFORMATION WAS RECEIVED ON 5/21/2025: THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2015 AND THE PATIENT LOOSE IMPLANTS WERE NOTICED AROUND (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 5/22/2025: A REVISION SURGERY HAS NOT OCCURRED. THE PATIENT IS DOING WELL; HOWEVER, WANTS THE ISSUE RESOLVED.

  Patient problems: Failure of Implant

  MAUDE report 22161390 ↗
• InjuryOct 27, 2017Device Slipped; Unstable

  ON 9/12/2017 IT WAS REPORTED VIA THE PATIENT'S ATTORNEY THAT A PATIENT HAD UNDERGONE A REVISION TKA PROCEDURE. IT WAS REPORTED THAT PATIENT'S FIRST ISSUES WITH THE EXPLANTED DEVICE WERE INSTABILITY, PAIN AND MOTION WHICH AROSE IN (B)(6) 2015. AT THE TIME OF INITIAL REPORT THE FOLLOWING ARTHREX PRODUCT WAS INDICATED: AR-503-TTTE, LOT 1206173. NEITHER THE ORIGINAL SURGERY DATE OR REVISION SURGERY DATE WERE PROVIDED DURING INITIAL REPORT. (B)(6). ADDITIONAL INFORMATION RECEIVED ON 10/02/2017: ON (B)(6) 2014 PATIENT UNDERWENT A BILATERAL TKA PROCEDURE. PATIENT HAS EXPERIENCED CONSTANT PAIN SINCE ORIGINAL SURGERY. ON (B)(6) 2016 EXAM AND RADIOGRAPHS WERE PERFORMED. ON (B)(6) 2016 SURGEON PERFORMED A REVISION RIGHT TKA DUE TO PAIN AND TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE IBALANCE TKA TIBIAL TRAY, AR-503-TTTE, LOT 1206173 ((B)(4)); IBALANCE PATELLA IMPLANT DOME, AR-504-PSC9, LOT 113601411 ((B)(4)); IBALANCE TKA BEARING, AR-513-BE13, LOT 113601345 ((B)(4)); AND IBALANCE TKA FEMORAL IMPLANT, AR-516-4R, LOT 108761406 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE. ADDITIONAL INFORMATION RECEIVED O

  Patient problems: Bacterial Infection; Fall

  MAUDE report 6983250 ↗
• InjuryApr 4, 2017Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2015 PATIENT UNDERWENT A RIGHT TKA PROCEDURE. PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2016 DURING WHICH THE TIBIAL BEARING WAS EXCHANGED (1220246-2016-00144 / (B)(4)). ON (B)(6) 2017 THE SURGEON PERFORMED A REVISION RIGHT TKA DUE TO PATIENT PAIN. IT WAS REPORTED THAT THE TIBIA WAS NOT LOOSE. DURING THE MARCH 2017 REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTD (LOT 1297049) ((B)(4) (B)(6)), FEMORAL IMPLANT AR-516-4R (LOT 1368092) ((B)(4) (B)(6)), PATELLA IMPLANT AR-504-PSC9 (LOT 113601437) ((B)(4) (B)(6)) AND BEARING IMPLANT AR-513-BD14 (LOT 113601329) ((B)(4) (B)(6)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT IS A FEMALE, DOB (B)(6). THE FOLLOWING WAS OBTAINED FROM THE PATIENT'S MEDICAL RECORDS: RECORDS DATE (B)(6) 2016: PATIENT HAD BEEN DOING WELL UNTIL TRIPPING AND FALLING ONTO A FLEXED KNEE APPROXIMATELY TWO WEEKS PRIOR TO THIS OFFICE VISIT. PATIENT HAS HAD SIGNIFICANT SWELLING SINCE THEN. PATIENT DENIED ANY INSTABILITY. X-RAYS REVIEWED - WELL POSITIONED PROSTHESIS. RECORDS DATED (B)(6) 2016: PATIENT HAS HAD CHRONIC PAIN AND SWELLING SINCE FALLING 7 WEEKS PRIOR WHILE CARRYING A CRATE

  Patient problems: Fall; Pain; Swelling

  MAUDE report 6456519 ↗