Arthrex® AR-516-5LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867109346), received between Jul 26, 2016 and Nov 29, 2018 — classified as 4 injuries.

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

• InjuryNov 29, 2018Patient-Device Incompatibility

  IT WAS ORIGINALLY REPORTED (B)(4) BY PATIENT'S ATTORNEY THAT PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2015 DURING WHICH THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-503-TTTE, TIBIAL TRAY, LOT 1315453; AR-516-5L, FEMORAL IMPLANT, LOT 1476178; AR-513-BE12, TIBIAL BEARING, LOT 113601433; AR-504-PSB8, PATELLA IMPLANT, LOT 113601439. SURGEON OFFICE RECORDS (B)(6) 2016: PATIENT STILL HAS SOME RESIDUAL STIFFNESS AND MILD DISCOMFORT. PATIENT REPORTED OLD PAIN IS GONE, PAIN IS BETTER THAN BEFORE SURGERY. PATIENT HAS PAIN ON AND OFF IN TIBIAL REGION AND REPORTED KNEE WILL SWELL ON OCCASION. SURGEON OFFICE RECORDS (B)(6) 2017: PATIENT REPORTED PAIN IN BOTH KNEES AND PAIN WITH WALKING IN BOTH KNEES. PATIENT REPORTED RIGHT KNEE HURTS MORE THAN LEFT KNEE. PATIENT DID NOT IMPROVE WITH STEROID INJECTIONS. ADDITIONAL INFORMATION OBTAINED (B)(6) 2018: PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 DUE TO PAINFUL LEFT TOTAL KNEE ARTHROPLASTY, MORBID OBESITY. OPERATIVE REPORT (B)(6) 2018: ALL ORIGINAL COMPONENTS WERE EXPLANTED. BEARING WAS REMOVED WITH COMPRESSION OF THE TIBIA. THE FEMUR WAS FOUND TO BE WELL FIXED. FEMUR AND PATELLA REQUIRED OSTEOTOMES AND/OR OSCIL

  Patient problems: Discomfort; Pain; Swelling

  MAUDE report 8116992 ↗
• 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, (B)(6).

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

  MAUDE report 7580282 ↗
• InjuryDec 9, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT UNDERWENT A LEFT TKA PROCEDURE DURING WHICH ARTHREX IBALANCE TKA DEVICES WERE IMPLANTED. ON (B)(6) 2015, WHILE AT PHYSICAL THERAPY, THE PATIENT'S THERAPIST NOTICED THAT THE KNEE WAS NOT CORRECTING. ON (B)(6) 2015, THE PATIENT WENT TO SEE THE ORIGINAL SURGEON WHO RECOMMENDED EITHER A LATERAL RELEASE OR A TOTAL REVISION SURGERY TO CORRECT THE KNEE. ON (B)(6) 2016 PATIENT WAS SEEN BY A NEW SURGEON FOR A SECOND OPINION AND A LEFT TKA REVISION SURGERY WAS PERFORMED ON (B)(6) 2016 BY THE NEW SURGEON AT A DIFFERENT FACILITY THAN THE ORIGINAL SURGERY FACILITY. PATIENT REPORTS THAT THE FOLLOWING ARTHREX DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: AR-503-TTTF, IBALANCE SIZE 5 TIBIAL TRAY, LOT: 108761211 ((B)(4) (B)(6)), AR-516-5L, FEMORAL IMPLANT, LOT 1373716 ((B)(4) (B)(6)) AND AR-513-BG10, BEARING IMPLANT, LOT 113601341 ((B)(4) (B)(6)). THE ORIGINAL ARTHREX PATELLA IMPLANT WAS LEFT IN THE PATIENT AND ANOTHER MANUFACTURER'S PRODUCT WAS USED TO COMPLETE THE TKA REVISION. THE PATIENT REQUESTED AND HAS KEPT THE EXPLANTED ARTHREX DEVICES.

  Patient problems: No Code Available

  MAUDE report 6157543 ↗
• InjuryJul 26, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2015, A PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION LEFT TKA PROCEDURE DUE TO PATIENT PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTE (LOT 1379201), FEMORAL IMPLANT AR-516-5L (LOT 1373716), BEARING IMPLANT AR-513-BE12 (LOT 113601433) AND PATELLA IMPLANT AR- 504-PSB8 (LOT 113601439). PATIENT, FEMALE, (B)(6). DURING THE REVISION PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: TIBIAL TRAY AR-513-T5 (LOT 10034400), FEMORAL IMPLANT AR-516-5L (LOT 1482387), BEARING IMPLANT AR-513-BF18 (LOT 113601335) AND PATELLA IMPLANT AR-504-PSC9 (LOT 113601511). PATIENT MEDICAL RECORDS OF (B)(6) 2016 NOTED PATIENT WAS EXPERIENCING RECURRENT SWELLING IN LEFT KNEE, ANY JARRING MOTION OF KNEE RECREATED PAIN IN KNEE AND PATIENT IS ABLE TO DO STAIRS ONE AT A TIME. EXAMINATION OF THE LEFT KNEE DEMONSTRATED SWELLING AND PALPATION OF THE LEFT KNEE DEMONSTRATED MEDIAL TIBIAL PLATEAU TENDERNESS AND LATERAL TIBIAL PLATEAU TENDERNESS. MILD EFFUSION OF THE LEFT KNEE WAS NOTED ALONG WITH PAIN WITH FLEXION. IT WAS NOTED PATIENT MAY HAVE MICROMOTION TIBIAL COMPONENT. PATIENT MEDICAL RECORDS OF (B)

  Patient problems: Arthralgia; Pain; Swelling

  MAUDE report 5822746 ↗