Arthrex® AR-503-TTTFRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867106734), received between Dec 9, 2016 and Sep 27, 2022 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (5 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Dec 17, 2015Terminated

   Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.

   Z-1195-2016 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2022Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY A PATIENTS LEGAL REPRESENTATIVE BY MAIL, RECEIVED ON 9/6/2022, THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT ON (B)(6) 2013. THE SURGERY WAS PERFORMED UTILIZING ARTHREX¿S IBALANCE TIBIAL TRAY AR-503-TTTF, LOT 108761150. THEREAFTER, THE PATIENT BEGAN TO EXPERIENCE PAIN, SWELLING AND DISCOMFORT IN HIS LEFT KNEE. ON (B)(6) 2020, HE PRESENTED TO A DIFFERENT SURGEON FOR EVALUATION. DURING THIS VISIT THE SURGEON INFORMED THE PATIENT OF THE POSSIBILITY OF PREMATURE MECHANICAL LOOSENING OF THE IBALANCE KNEE PROSTHESIS AND REVISION SURGERY WAS RECOMMENDED. ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION PROCEDURE AT (B)(6). ACCORDING TO THE PATIENT, THE SURGEON NOTED THAT THE TIBIAL COMPONENT WAS GROSSLY LOOSE DURING THE REVISION AND THAT HIS TIBIAL TRAY DEVICE WAS SUBJECT TO A RECALL. ACCORDING TO THE PART/LOT NUMBERS IDENTIFIED IN THE PHOTOGRAPHS THE PATIENT¿S LEGAL REPRESENTATIVE PROVIDED, THE SPECIFIC TIBIAL TRAY IS NOT SUBJECT TO A RECALL.

  Patient problems: Discomfort; Failure of Implant; Pain; Swelling/ Edema

  MAUDE report 15493468 ↗
• InjuryMar 23, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2014. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE; AR-516-7R (LOT: 108761331), AR-503-TTTF (LOT: 108761203), AR-504-PSC9 / (LOT: 113601324), AR-503-BF09 / (LOT: 113601236). IT WAS REPORTED THAT THE TIBIAL BASEPLATE WAS EXTREMELY LOOSE AND THAT THE PATIENT HAS SUBSTANTIAL SYNOVITIS THAT REQUIRED A COMPLETE SYNOVECTOMY ALONG WITH A REVISION TOTAL KNEE ARTHROPLASTY. THE PATIENT UNDERWENT A RIGHT TOTAL KNEE REVISION SURGERY ON (B)(6) 2019. THE REVISION PROCEDURE TOOK PLACE AT THE SAME FACILITY AS THE PRIMARY, AND WAS PERFORMED BY THE SAME SURGEON. AR-503-TTTF (LOT: 108761203) WAS EXPLANTED DURING THE REVISION SURGERY. THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURER'S DEVICES.

  Patient problems: Failure of Implant; Synovitis

  MAUDE report 11552786 ↗
• InjuryMar 22, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2014. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE; AR-504-PSD0 (LOT: 113601415), AR-503-TTTF (LOT: 108761211), FEMORAL COMPONENT (PART/LOT UNKNOWN), TIBIAL BEARING (PART/LOT UNKNOWN). AFTER THE PRIMARY SURGERY, THE PATIENT DEVELOPED PROGRESSIVE PAIN WITH X-RAYS DEMONSTRATING EVIDENCE OF LOOSENING OF THE TIBIAL TRAY AND BONE SCAN REVEALED SOME POSSIBLE LOOSENING OF THE FEMORAL IMPLANT. THE PATIENT'S SYMPTOMS WERE UNRESPONSIVE TO A LENGTHY TRIAL OF CONSERVATIVE TREATMENT, AND THE PATIENT WAS INDICATED FOR A REVISION RIGHT TOTAL KNEE ARTHROPLASTY. THE REVISION PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON ON (B)(6) 2020, AND TOOK PLACE AT A DIFFERENT FACILITY THAN THE PRIMARY. DURING THE REVISION SURGERY, AR-503-TTTF (LOT: 108761211) WAS EXPLANTED. THE PATELLA WAS EXAMINED AND WAS NOTED TO BE 26 MM THICK. THE PATELLA ITSELF HAD NO SIGNIFICANT WEAR AND APPEARED TO BE WELL FIXED. THE SURGEON DECIDED TO SALVAGE THE PATELLA. THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURER'S DEVICES.

  Patient problems: Failure of Implant

  MAUDE report 11547728 ↗
• InjurySep 5, 2019Loose or Intermittent Connection; Nonstandard Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. DURING THE 2014 PROCEDURE THE PATELLA WAS NOT RESURFACED AND THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: TIBIAL TRAY, AR-503-TTTF, (LOT 971202); FEMORAL IMPLANT, AR-503-PSRF, (LOT 108761207); BEARING IMPLANT, AR-503-BF12, (LOT 113601237). ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION RIGHT TKA PROCEDURE. ADDITIONAL INFORMATION PROVIDED (B)(6) 2019: REVISION WAS DUE TO TIBIAL LOOSENING. ALL ORIGINAL 2014 DEVICES WERE EXPLANTED DURING THE REVISION. THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURER'S PRODUCTS. THE DEVICES WILL NOT BE RETURNING FOR EVALUATION AS IT WAS REPORTED BY THE SALES REP THAT RETURNING THE DEVICES IS AGAINST HOSPITAL POLICY.

  Patient problems: No Information

  MAUDE report 8964735 ↗
• InjuryMar 1, 2019Loose or Intermittent Connection; Nonstandard Device

  IT HAS BEEN REPORTED ON OCTOBER 4, 2018 BY THE PATIENT'S LEGAL REPRESENTATIVE THAT PATIENT HAD UNDERGONE A LEFT TKA PROCEDURE ON (B)(6) 2015 AND A RIGHT TKA PROCEDURE ON (B)(6) 2015. SPECIFIC INFORMATION REGARDING THE PATIENT'S ISSUES HAVE NOT BEEN PROVIDED. NO REVISION PROCEDURES HAVE TAKEN PLACE THAT ARTHREX IS AWARE OF. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE LEFT TKA ON (B)(6) 2015: TIBIAL TRAY IMPLANT, AR-503-TTTH, LOT 1358298, FEMORAL IMPLANT, AR-517-7L, LOT 1438515, BEARING IMPLANT, AR-513-RH, LOT 113601428. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED DURING THE RIGHT TKA ON (B)(6) 2015: TIBIAL TRAY IMPLANT, AR-503-TTTF, LOT 1380224, FEMORAL IMPLANT, AR-517-7R, LOT 1738528, BEARING IMPLANT, AR-512-RF08, LOT 113601434, PATELLA IMPLANT, AR-504-PSC9, LOT 113601527. ADDITIONAL INFORMATION PROVIDED 2/4/2019: MEDICAL RECORDS DATED (B)(6) 2017 NOTED THE RIGHT KNEE HAS VARUS MALALIGNMENT WITH SUBSIDENCE AND LOOSENING. IT WAS ALSO RECOMMENDED THAT THE PATIENT LOSE WEIGHT AS HIS BMI WAS CLOSER TO 46. ON (B)(6) 2018 THE PATIENT UNDERWENT A REVISION RIGHT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE RIGHT TIBIAL TRAY, FEMORAL IMPLANT, BEARING IMPLANT A

  Patient problems: No Information

  MAUDE report 8381860 ↗
• InjuryJan 7, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO A LOOSE TIBIAL TRAY AFTER HAVING A TOTAL KNEE REPLACEMENT DONE ON (B)(6) 2015. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE ORIGINAL TOTAL KNEE REPLACEMENT. AR-503-TTTF / LOT: 108761213, AR-516-5L / LOT: 1252985, AR-513-BF14 / LOT: 113601343, AR-504-PSD0 / LOT: 113601430. THE REP CONFIRMED THAT ALL ARTHREX PARTS THAT WERE IMPLANTED DURING THE ORIGINAL SURGERY, WERE EXPLANTED DURING THE (B)(6) 2018 REVISION SURGERY. THE REVISION SURGERY TOOK PLACE AT THE SAME FACILITY AND WAS PERFORMED BY THE SAME SURGEON WHO PERFORMED THE INITIAL PROCEDURE. SALES REP WAS PRESENT DURING THE ORIGINAL AND REVISION SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8221879 ↗
• 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 6157542 ↗