Arthrex® AR-513-BE12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867107274), received between Jul 26, 2016 and Jan 18, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 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.

• InjuryJan 18, 2017Loose or Intermittent Connection; Nonstandard Device; Device Dislodged or Dislocated

  IT WAS REPORTED BY A PATIENT THAT SHE HAD UNDERGONE A LEFT TKA PROCEDURE ON (B)(6) 2015. PATIENT STATES THAT ALMOST IMMEDIATELY AFTER THE SURGERY, WITHIN WEEKS, THE PATIENT BEGAN TO HAVE PROBLEMS WITH SWELLING WHICH REQUIRED DRAINING SEVERAL TIMES. PATIENT STATES THERAPY WAS VERY DIFFICULT WITH HER JOINT CONTINUALLY POPPING OUT OF PLACE AND SHE WAS EXPERIENCING A POPPING SOUND. PATIENT SOUGHT A SECOND OPINION AND THE SECOND SURGEON CONCLUDED THAT THE JOINT WAS LOOSE AND WOULD NEED TO BE REPLACED. SURGEON RECOMMENDED WAITING A YEAR FROM ORIGINAL SURGERY TO ALLOW HER BODY TO HEAL. ON (B)(6) 2016 PATIENT UNDERWENT A REVISION LEFT TKA PROCEDURE AT A DIFFERENT FACILITY, PERFORMED BY THE SECOND OPINION SURGEON. DURING THE REVISION SURGERY THE NEW SURGEON EXPLANTED THE FOLLOWING ARTHREX PRODUCTS: TIBIAL TRAY, AR-503-TTTE, LOT 1191338 ((B)(4)), FEMORAL IMPLANT, AR-516-4L, LOT 108761334 ((B)(4)), BEARING IMPLANT, AR-513-BE12, LOT 113601433 ((B)(4)) AND PATELLA IMPLANT, AR-504-PSC9, LOT 113601324 ((B)(4)). THE NEW SURGEON COMPLETED THE PROCEDURE USING ANOTHER MANUFACTURER'S PRODUCT. PATIENT HAD CALLED THE FDA AND WAS INSTRUCTED TO CONTACT ARTHREX TO REPORT THE REVISION SURGERY. MEDICAL RECOR

  Patient problems: Fluid Discharge; Swelling

  MAUDE report 6259670 ↗
• 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, DOB (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

  Patient problems: Pain; Swelling

  MAUDE report 5822761 ↗
• 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, DOB 06/23/59. 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

  Patient problems: Pain; Swelling

  MAUDE report 5822752 ↗