Arthrex® AR-513-T5Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867187887), received between Mar 31, 2017 and May 9, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2024Unintended Movement; Unintended Movement

  ON 09/23/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-513-T5 TIBIAL BEARING POLY WAS FOUND TO BE SOMEWHAT LOOSE UPON IMPLANTATION TO TIBIAL TRAY. THIS WAS DISCOVERED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277004 ↗
• InjuryDec 7, 2020Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE A PATIENT HAD UNDERGONE A TKA PROCEDURE (B)(6) 2019. DURING THE 2019 PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-513-T5, IBALANCE TKA MODULAR TIBIAL TRAY (LOT 10280798), AR-513-BF18, IBALANCE TKA BEARING IMPLANT (LOT 113601824), AR-516-6L, IBALANCE FEMORAL IMPLANT (LOT 10221540), AR-524-PSD0, PATELLA IMPLANT DOME (LOT 132581832). ROUGHLY 6 MONTHS POST OP THE PATIENT BEGAN HAVING ISSUES WITH FULLY EXTENDING THE KNEE. IT WAS REPORTED THERE WAS A POST-OP DISENGAGEMENT OF THE POLY FROM THE TRAY. THE PATIENT UNDERWENT A REVISION SURGERY AT THE SAME FACILITY BY THE SAME SURGEON. DURING THE REVISION ALL OF THE ORIGINAL ARTHREX DEVICES WERE EXPLANTED. TO COMPLETE THE REVISION PROCEDURE ANOTHER MANUFACTURER'S PRODUCT WAS USED. RISK MANAGEMENT DEPARTMENT AT THE FACILITY HAS POSSESSION OF THE EXPLANTED DEVICES. ADDITIONAL INFORMATION PROVIDED 11/23/20: THE REVISION PROCEDURE TOOK PLACE (B)(6) 2020.

  Patient problems: Loss of Range of Motion

  MAUDE report 10962335 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A MEDICAL PROFESSIONAL THAT A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE (B)(6) 2018. THE PATIENT LATER UNDERWENT A REVISION TKA PROCEDURE SOMETIME IN (B)(6) 2020. ADDITIONAL INFORMATION OBTAINED 10/27/2020: AN ARTHREX SALES REP HAS OBTAINED AND PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: PATIENT HAD REPORTED TO A DIFFERENT SURGEON AS HAVING PAIN ON THE OPERATIVE SIDE. THE SECOND SURGEON PERFORMED A REVISION TKA, (B)(6) 2020 AND REVISED THE TIBIAL COMPONENT. THE FEMUR WAS FOUND TO BE WELL FIXATED AT THE TIME OF REVISION. THE FOLLOWING ORIGINAL IMPLANT DEVICES WERE EXPLANTED AT THE TIME OF REVISION: AR-513-T5, IBALANCE TKA TIBIAL TRAY, LOT 10183321, AR-523-B510, IBALANCE TKA TIBIAL BEARING IMPLANT (SIZE 5), LOT 5791643. THE FOLLOWING ORIGINAL IMPLANT DEVICES WERE LEFT IN THE PATIENT AT THE TIME OF REVISION: AR-516-6L, IBALANCE TKA FEMORAL IMPLANT, LOT 10053281, AR-524-PSC9, IBALANCE PATELLA IMPLANT, LOT 132581743. THE FOLLOWING DEVICES WERE IMPLANTED AT THE TIME OF REVISION: AR-513-T4, IBALANCE TKA MODULAR TIBIAL TRAY, LOT 10572760, AR-513-BE-16, IBALANCE TKA BEARING IMPLANT (SIZE 4), LOT 113601819, AR-513-1050. IBALANCE TKA TIBIAL STEM, LOT 10018103.

  Patient problems: Pain

  MAUDE report 10842940 ↗
• InjuryJun 7, 2018Unstable

  IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION LEFT TKA PROCEDURE DUE TO PATIENT PAIN ((B)(4)/MFR REPORT # 1220246-2016-00295). ON (B)(6) 2017, A DIFFERENT SURGEON PERFORMED A SECOND REVISION DUE TO INSTABILITY. DURING THIS REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-513-T5 (LOT 1003440), FEMORAL IMPLANT AR-516-5L (LOT 1482387), BEARING IMPLANT AR-513-BF-18 (LOT 113601335) AND PATELLA IMPLANT AR-504-PSC9 (LOT 113601511). THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURERS PRODUCT. PATIENT FEMALE, DOB (B)(6).

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 7580277 ↗
• InjuryMar 31, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE PROCEDURE ON (B)(6) 2017 DURING WHICH THE FOLLOWING COMPONENTS WERE IMPLANTED: AR-503-A510 ((B)(4), MEDWATCH 1220246-2017-00103), AR-504-PSC9 ((B)(4) - MEDWATCH 1220246-2017-00104), AR-513-T5 ((B)(4) - MEDWATCH 1220246-2017-00105) AND AR-517-6R ((B)(4) - MEDWATCH 1220246-2017-00106). POST-OP I&D (IRRIGATION AND DEBRIDEMENT) DONE ON (B)(6) 2017, PUS WAS FOUND INSIDE THE KNEE. ALL IMPLANTS WERE EXPLANTED AND REPLACED WITH CEMENT SPACER MIXED WITH ANTIBIOTICS. MALE (B)(6). ADDITIONAL INFORMATION OBTAINED 3/30/17: IT WAS REPORTED THAT ON (B)(6) 2017 PATIENT BEGAN EXPERIENCING MARKED AND SEVERE WELLING AND SPONTANEOUS DRAINING. AT SURGEON OFFICE SAME DAY CULTURES WERE TAKEN AND WERE POSITIVE FOR AN UNSPECIFIED INFECTION DISEASE. ON (B)(6) 2017 PATIENT WENT IN FOR A POST OP I&D AND PUS WAS FOUND INSIDE PATIENT KNEE. DEVICES WERE THEN EXPLANTED. PATIENT WAS KEPT OVERNIGHT AND DISCHARGED (B)(6) 2017. CULTURE/PATHOLOGY WAS PERFORMED DURING REVISION. RESULTS HAVE NOT BEEN PROVIDED. PATIENT IS EXPECTED TO HAVE CEMENT SPACERS LEFT IN 3-6 MONTH, AFTER WHICH SURGEON WILL MOST LIKELY USE ANOTHER MANUFACTURER'S PRODUCT. PATIENT WILL NEED BOTH STEMS

  Patient problems: Swelling; Unspecified Infection

  MAUDE report 6450271 ↗