Arthrex® AR-503-TTTGRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867106741), received between Aug 16, 2016 and Jun 6, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (3 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.

• 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 6/17/2015 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 22161500 ↗
• InjuryNov 4, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT HAD UNDERGONE A BI-LATERAL TKA PROCEDURE. ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION RIGHT TKA PROCEDURE DUE TO PAIN AND TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE FOLLOWING ORIGINAL ARTHREX IMPLANT DEVICES WERE EXPLANTED: AR-503-TTTG, TIBIAL TRAY IMPLANT (LOT 108761215); AR-516-7R, FEMORAL IMPLANT (LOT 108761338); AR-513-BG11, TIBIAL BEARING IMPLANT (LOT 113601405); AR-504-PSC9, PATELLA IMPLANT (LOT 113601430). THE REVISION PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER MANUFACTURER'S DEVICES.

  Patient problems: Pain

  MAUDE report 9272291 ↗
• InjuryMar 8, 2017Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2013 A PATIENT UNDERWENT A BILATERAL TKA PROCEDURE. ON (B)(6) 2017 THE SURGEON PERFORMED A REVISION LEFT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTG, LOT 108761204 ((B)(4)), AND BEARING IMPLANT, AR-503-BG08, LOT 654433 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX DEVICES: TIBIAL TRAY, AR-513-T7, LOT 10024600, BEARING IMPLANT, AR-513-BH18, LOT 113601405 AND STEM EXTENSION IMPLANT, AR-513-1450, LOT 10024600. PATIENT WAS A MALE, (B)(6). ADDITIONAL INFORMATION FROM PATIENT MEDICAL RECORDS: ON (B)(6) 2014: ASSESSMENT - ANKYLOSIS OF LEFT KNEE, EFFUSION OF LOWER LEG JOINT. PATIENT HAS SOME PLAY IN KNEE BUT NOT ENOUGH FOR SURGERY AT TIME OF NOTATION. ON (B)(6) 2015: PATIENT HAS LAXITY IN LEFT KNEE. EXAMINATION OF THE LEFT KNEE DEMONSTRATED SWELLING. PALPATION OF THE LEFT KNEE DEMONSTRATED INFERIOR POLE PATELLA TENDERNESS, MEDIAL AND LATERAL JOINT LINE TENDERNESS AND PAIN WITH FLEXION. ON (B)(6) 2016: X-RAY FINDINGS LEFT KNEE, PROSTHESIS IN PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING, OR STRESS SHIELDING.

  Patient problems: Failure of Implant; Joint Swelling

  MAUDE report 6386975 ↗
• InjurySep 9, 2016Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT UNDERWENT A BI-LATERAL TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION LEFT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTG (LOT 108761208) ((B)(4)), FEMORAL IMPLANT AR-503-PSLH (LOT 108761213) ((B)(4)), BEARING IMPLANT AR-503-BG12 (LOT 77941245) ((B)(4)) AND PATELLA IMPLANT AR-504-PSC9 (LOT 113601324) ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED UPON EXAMINATION OF THE LEFT KNEE WITH PALPATION THE KNEE DEMONSTRATED MEDIAL AND LATERAL JOINT LINE TENDERNESS (DIFFUSE TENDERNESS THROUGHOUT THE KNEE AND HYPERSENSITIVITY TO LIGHT TOUCH) WITH TRACE EFFUSION OF THE LEFT KNEE. RECORDS NOTED LEFT KNEE X-RAY SHOWED PROSTHESIS IN PLACE WITH MILD LUCENCY AROUND THE TIBIAL COMPONENT.

  Patient problems: Discomfort; Increased Sensitivity

  MAUDE report 5940614 ↗
• InjurySep 6, 2016Device Slipped

  IT WAS REPORTED THAT PATIENT UNDERWENT A BI-LATERAL TKA PROCEDURE ON (B)(6) 2014. DUE TO A LOOSE TIBIA AND FEMUR THE PATIENT UNDERWENT A REVISION RIGHT TKA PROCEDURE ON (B)(6) 2016. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE FOLLOWING ARTHREX PRODUCTS: TIBIAL TRAY AR-503-TTTG (LOT 108761208 ) ((B)(4)), FEMORAL IMPLANT AR-503-PSRH (LOT 108761219) ((B)(4)), BEARING IMPLANT AR-503-BG15 (LOT 113601227 ) ((B)(4)) AND PATELLA IMPLANT AR-504-PSC9 (LOT 108601324) ((B)(4)). THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, DOB (B)(6) 1964. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT HAS HAD CHRONIC KNEE PAIN. EXAMINATION OF THE RIGHT WITH PALPATION DEMONSTRATED MEDIAL JOINT LINE TENDERNESS AND LATERAL JOINT LINE TENDERNESS (DIFFUSE TENDERNESS THROUGHOUT THE KNEE, HYPERSENSITIVITY TO LIGHT TOUCH) WITH TRACE EFFUSION OF THE RIGHT KNEE. RECORDS NOTED THAT RIGHT KNEE X-RAY SHOWED PROSTHESIS IN PLACE WITH MILD LUCENCY AROUND THE TIBIAL COMPONENT.

  Patient problems: Pain

  MAUDE report 5930768 ↗
• InjuryAug 16, 2016Nonstandard Device; Unstable

  IT WAS REPORTED THAT ON (B)(6) 2015 PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION LEFT TKA DUE TO PATIENT PAIN. DURING THE REVISION PROCEDURE, THE SURGEON EXPLANTED THE TIBIAL TRAY AR-TTTG (LOT 1206179) ((B)(4))AND BEARING IMPLANT AR-513-BG09 (LOT 113601349) ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PRODUCTS: TIBIAL TRAY AR-513-T7 (LOT 10013886), BEARING IMPLANT AR-503-BH15 (LOT 113601229) AND STEM EXTENSION IMPLANT AR-513-1450 (LOT 10024348). PATIENT WAS A MALE, AGE (B)(6), DOB (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT CONTINUES TO HAVE RECURRENT SWELLING. ASPIRATIONS/INJECTIONS HAVE PROVIDED ONLY 3 DAYS OF RELIEF. BURNING AND STINGING SENSATION LATERAL WAS NOTED ALONG WITH INSTABILITY WHEN WALKING MOSTLY DECLINES. RECORDS NOTED ANOTHER ASPIRATION AND INJECTION PROCEDURE WAS PERFORMED. MEDICAL RECORDS DATED (B)(6) 2016 NOTED RECURRENT SWELLING, PAIN AND INSTABILITY ALONG WITH BURNING AND STINGING SENSATION LATERAL WITH PAIN GLOBAL. PATIENT REPORTED VERY LIMITED ACTIVITY LEVEL. ANY INCREASED ACTIVITY CAUSES KNEE SWELLING. REPORT NOTES PATIENT STATED HE DOES NOT HAVE PAIN IN TIBIAL

  Patient problems: Burning Sensation; Pain; Swelling

  MAUDE report 5878402 ↗
• InjuryAug 16, 2016Loose or Intermittent Connection; Unstable

  IT WAS REPORTED THAT ON (B)(6) 2015 PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION LEFT TKA DUE TO PATIENT PAIN. DURING THE REVISION PROCEDURE, THE SURGEON EXPLANTED THE TIBIAL TRAY AR-TTTG (LOT 1206179) ((B)(4)) AND BEARING IMPLANT AR-513-BG09 (LOT 113601349) ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PRODUCTS: TIBIAL TRAY AR-513-T7 (LOT 10013886), BEARING IMPLANT AR-503-BH15 (LOT 113601229) AND STEM EXTENSION IMPLANT AR-513-1450 (LOT 10024348). PATIENT WAS A MALE, AGE (B)(6), DOB (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT CONTINUES TO HAVE RECURRENT SWELLING. ASPIRATIONS/INJECTIONS HAVE PROVIDED ONLY 3 DAYS OF RELIEF. BURNING AND STINGING SENSATION LATERAL WAS NOTED ALONG WITH INSTABILITY WHEN WALKING MOSTLY DECLINES. RECORDS NOTED ANOTHER ASPIRATION AND INJECTION PROCEDURE WAS PERFORMED. MEDICAL RECORDS DATED (B)(6) 2016 NOTED RECURRENT SWELLING, PAIN AND INSTABILITY ALONG WITH BURNING AND STINGING SENSATION LATERAL WITH PAIN GLOBAL. PATIENT REPORTED VERY LIMITED ACTIVITY LEVEL. ANY INCREASED ACTIVITY CAUSES KNEE SWELLING. REPORT NOTES PATIENT STATED HE DOES NOT HAVE PAIN IN TIBIAL

  Patient problems: Burning Sensation; Limited Mobility Of The Implanted Joint; Pain; Swelling

  MAUDE report 5878392 ↗