Arthrex® AR-503-TTTHRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867106758), received between Aug 29, 2016 and May 18, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Nonstandard Device” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2021Nonstandard Device; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT¿S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE PROCEDURE ON (B)(6) 2014, AND IS EXPERIENCING UNKNOWN ISSUES WITH THE KNEE REPLACEMENT. THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE PRIMARY PROCEDURE: AR-503-TTTH (LOT: 780842), AR-516-7R (LOT: 108761412) X 2, AR-513-BH10 (LOT: 113601339), AR-504-PSD0 (LOT: 113601323). TO DATE NO REVISION HAS BEEN REPORTED. THE PATIENT ALSO HAD A LEFT TOTAL KNEE PROCEDURE ON (B)(6) 2014 WHICH WAS REVISED ON (B)(6) 2019 (SEE CASE (B)(4)). ADDITIONAL INFORMATION RECEIVED ON 4/26/2021: ARTHREX HAS RECEIVED CONFIRMATION THAT THE PATIENT'S RIGHT KNEE WAS REVISED ON (B)(6) 2021. NO ADDITIONAL DETAILS PERTAINING TO THE REVISION SURGERY HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11841119 ↗
• InjuryMar 23, 2021Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE PROCEDURE ON (B)(6) 2014. THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE PRIMARY PROCEDURE; AR-503-TTTH / (LOT: 108761229), AR-504-PSD0 / (LOT: 113601415), AR-513-BH08 / (LOT: 113601338), AR-516-7L / (LOT: 108761342). THE PATIENT UNDERWENT A LEFT KNEE REVISION WITH REVISION OF BOTH FEMORAL AND TIBIAL COMPONENTS ON (B)(6) 2019. THE REVISION SURGERY WAS PERFORMED BY A DIFFERENT SURGEON, AND TOOK PLACE AT A DIFFERENT FACILITY THAN THE PRIMARY. DURING THE REVISION SURGERY, IT WAS DISCOVERED THAT THE BONE-CEMENT INTERFACE BETWEEN THE FEMUR AND FEMORAL COMPONENT WAS DISENGAGED CIRCUMFERENTIALLY AROUND THE FEMORAL COMPONENT. THE FEMORAL COMPONENT WAS ABLE TO BE REMOVED WITH MINIMAL BONE LOSS. THE TIBIAL COMPONENT WAS NOTED TO BE GROSSLY LOOSE AND WAS ABLE TO BE REMOVED BY HAND WITH NO DIFFICULTY. THE PATELLAR COMPONENT WAS NOTED TO BE INTACT. THE PATIENT WAS REVISED USING ANOTHER MANUFACTURER'S DEVICES. THE PATIENT ALSO HAD A RIGHT TOTAL KNEE PROCEDURE ON (B)(6) 2014. THERE HAS BEEN NO REPORT OF A REVISION SURGERY FOR THE RIGHT KNEE.

  Patient problems: Failure of Implant

  MAUDE report 11553004 ↗
• InjuryDec 12, 2019Nonstandard Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY THE PATIENT THAT HE HAD TOTAL KNEE RECONSTRUCTION ON (B)(6) 2015. ABOUT TWO YEARS AGO THE PATIENT STARTED EXPERIENCING PAIN IN THE KNEE. PER THE PATIENT, X-RAYS WERE TAKEN AND IT WAS DETERMINED THE KNEE IS NOW LOOSE. PATIENT IS SCHEDULED FOR A REVISION LEFT TKA SURGERY ON (B)(6) 2019. ADDITIONAL INFORMATION OBTAINED 10/10/2019: THE PATIENT HAD UNDERGONE A BI-LATERAL TKA PROCEDURE ON (B)(6) 2015. PATIENT REPORTED THAT BONE SCANS WERE TAKEN WHICH CONFIRMED HIS LEFT TIBIAL IMPLANT TO BE LOOSE. PATIENT STATED HE HAS DEALT WITH THE PAIN AND ACCOMPANYING ISSUES FOR OVER TWO YEARS, TAKING 1000 MG OF TYLENOL AND 800 MG OF IBUPROFEN DAILY OVER PAST SEVERAL YEARS, BUT REPORTS HIS LEG IS NOW BOWED AND CAUSING SCIATICA TYPE PAIN IN HIS HIP. DURING THE (B)(6) 2015 ORIGINAL PROCEDURE THE PATIENT HAD THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED IN HIS LEFT KNEE: AR-503-TTTH, TIBIAL TRAY IMPLANT (LOT 1358298), AR-516-7L, FEMORAL IMPLANT (LOT 1373719), AR-513-BH12, BEARING IMPLANT (LOT 113601409), AR-504-PSD0, PATELLA IMPLANT (LOT 113601430). ADDITIONAL INFORMATION OBTAINED 11/19/2019: CONFIRMATION WAS RECEIVED THAT THE PATIENT'S LEFT TKA REVISION PROCEDURE TOOK PLACE AS SCHEDULE

  Patient problems: Pain

  MAUDE report 9457411 ↗
• InjuryOct 18, 2019Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A RIGHT TKA PROCEDURE ON (B)(6) 2015. DURING THE ORIGINAL PROCEDURE THE PATELLA WAS RESURFACED. THE PATIENT WAS EXPERIENCING PAIN AND UNDERWENT A REVISION RIGHT TKA PROCEDURE ON (B)(6) 2019. THE REVISION PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER MANUFACTURER'S PRODUCT. DURING THE REVISION THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: TIBIAL TRAY IMPLANT, AR-503-TTTH, LOT 1337240, FEMORAL IMPLANT, AR-516-7R, LOT 108761331, BEARING IMPLANT, AR-513-BH12, LOT 113601409, PATELLA IMPLANT, AR-504-PSC9, LOT 113601430.

  Patient problems: Pain

  MAUDE report 9207322 ↗
• InjuryFeb 18, 2019Loose or Intermittent Connection; Nonstandard Device

  IT WAS REPORTED VIA THE PATIENT¿S LEGAL REPRESENTATIVE THAT ON (B)(6) 2015 THAT THE PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2018 THE SURGEON PERFORMED A LEFT TIBIAL COMPONENT REVISION ARTHROPLASTY, TIBIAL AUGMENT, STEM EXTENSION PROCEDURE DUE TO MECHANICAL LOOSENING OF THE TIBIAL TRAY. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE ARTHREX TIBIAL TRAY AR-503-TTTH (LOT 1358298) AND ARTHREX BEARING AR-513-BH12 (LOT 113601341). THEREAFTER, THE SURGEON IMPLANTED THE FOLLOWING ARTHREX IBALANCE DEVICES: MODULAR TIBIAL TRAY (LOT 10141889), STEM EXTENSION (LOT 10024349), TIBIAL AUGMENT WITH LOCKING SCREW (LOT 10017209) AND BEARING(LOT 113601336). (THE SPECIFIC CATALOG NUMBERS AND SIZES OF THE NEW IMPLANTS ARE UNKNOWN). ACCORDING TO THE REVISION OPERATIVE REPORT, THE FEMORAL AND PATELLAR COMPONENTS WERE WELL FIXED AND APPEARED IN EXCELLENT CONDITION. THE TIBIAL COMPONENT WAS GROSSLY LOOSE AND WAS EASILY REMOVED FROM THE PATIENT. THE SURGEON NOTED THAT THE CEMENT WAS COMPLETELY DEBONDED FROM THE UNDERSURFACE OF THE COMPONENT. THE CEMENT REMAINED WELL FIXED TO THE TIBIAL BONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8348075 ↗
• InjuryOct 24, 2018Nonstandard Device; Patient-Device Incompatibility; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT HAD UNDERGONE A LEFT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2015. THE PATIENT'S POST OPERATIVE FOLLOW UP RECORDS NOTE THAT THE PATIENT REPORTED A FALL (LANDING ON BOTH KNEES) WITHIN SIX WEEKS FOLLOWING SURGERY. THE RECORDS ALSO INDICATE THAT THE PATIENT HAD MANY FALL AFTER THAT; "TOO MANY TO COUNT" AND THAT THE PATIENT IS MORBIDLY OBESE (BMI 40+ PRE AND POST SURGERY) WHICH IS CONTRAINDICATED FOR THIS DEVICE. DUE TO TIBIAL LOOSENING THE PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION PROCEDURE ON (B)(6) 2017. OP REPORT FOR THE (B)(6) 2017 PROCEDURE NOTED THAT TIBIAL COMPONENT WAS LOOSE. DURING THE REVISION THE FOLLOWING ARTHREX IMPLANTS WERE EXPLANTED: AR-503-TTTH TIBIAL IMPLANT (LOT 1337230), AR-516-7L FEMORAL IMPLANT (LOT 1528146), AR-513-BH11 BEARING IMPLANT (LOT 113601340) AND AR-504-PSD0 PATELLA IMPLANT (LOT 113901439). TO COMPLETE THE REVISION PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT.

  Patient problems: Failure of Implant; Fall

  MAUDE report 8001589 ↗
• InjuryOct 8, 2018Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED THAT ON (B)(6) 2015 A PATIENT UNDERWENT A TOTAL KNEE PROCEDURE. THE TIBIAL TRAY IMPLANTED DURING THIS PROCEDURE WAS AR-503TTTH, LOT 1380710. PATIENT DEVELOPED A SERIOUS INFECTION IN HIS KNEE WHICH REQUIRED HAVING TO HAVE FLUID DRAWN FROM HIS KNEE, THE PARTS THEN HAD TO BE EXPLANTED IN A SECOND SURGERY WHERE A TEMPORARY SPACER WAS PUT IN PLACE, HE THEN UNDERWENT A LENGTHY SERIES OF IV ANTIBIOTICS AND EVENTUALLY HAD ANOTHER SURGERY TO REDO THE KNEE WITH NEW IMPLANTS. PATIENT IS CURRENTLY DOING WELL. PATIENT DID NOT HAVE ALL OF HIS RECORDS AVAILABLE AT THE TIME OF CALL SO ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION OBTAINED 9/21/18: PATIENT UNDERWENT A RIGHT TKA PROCEDURE ON (B)(6) 2015 DURING WHICH THE FOLLOWING DEVICES WERE IMPLANTED: TIBIAL TRAY IMPLANT, AR-503-TTTH, LOT 1380710; FEMORAL IMPLANT, AR-516-7R, LOT 1355182; TIBIAL BEARING IMPLANT, AR-513-BH12, LOT 113601341; AND PATELLA IMPLANT, AR-504-PSD0, LOT 113601439. ALMOST IMMEDIATELY AFTER HAVING THE PROCEDURE THE PATIENT BEGAN TO HAVE INFECTION SYMPTOMS WHICH INCLUDED: SWELLING, REDNESS AND THE INCISION WAS LEAKING FLUID INCLUDING BLOOD. ON (B)(6) 2015 THE PATIENT'S KNEE WAS DRAINED T

  Patient problems: Erythema; Fluid Discharge; Swelling; Unspecified Infection

  MAUDE report 7943071 ↗
• InjuryJul 19, 2018Loose or Intermittent Connection; Unstable; Unintended Movement

  IT WAS INITIALLY REPORTED BY PATIENT THROUGH THE ARTHREX WEBSITE, THAT THE PATIENT HAD TOTAL KNEE REPLACEMENT PROCEDURE ON BOTH KNEES USING ARTHREX PRODUCTS. (REFERENCE (B)(4)) PATIENT PROVIDED THE FOLLOWING INFORMATION 2/13/18: INITIAL SURGERY WAS (B)(6) 2013. TWO YEARS AFTER SURGERY PATIENT STARTED TO HAVE SWELLING AND PAIN IN HIS KNEE. SURGEON HAD DRAINED PATIENT'S KNEE THREE DIFFERENT TIMES (AROUND EVERY 6 MONTHS), WHICH BROUGHT HIM NO RELIEF. SURGEON INFORMED PATIENT THAT THE COMPOUND (CEMENT) USED TO ADHERE THE IMPLANT WAS COMING LOOSE AND HE WAS MOST LIKELY GOING TO REQUIRE A REPLACEMENT. PATIENT STATED HIS LEFT KNEE IS GETTING WORSE AND HIS KNEE "SLIPS OUT OF PLACE". PATIENT REPORTED INSTABILITY AND PAIN IN BOTH KNEES THAT IS SO BAD THAT SOMETIMES HE FALLS. PATIENT SAID HIS RIGHT KNEE IS STARTING TO HAVE THE SAME PROBLEMS. WHEN PATIENT WALKS BOTH KNEES SHIFT. PATIENT STATED HE HAS PICTURES THAT SHOW A "SEPARATION" OF THE IMPLANT. ARTHREX REQUESTED THAT IF A REVISION IS PERFORMED, WOULD HE BE WILLING TO RELEASE THE PRODUCT TO ARTHREX SO THAT THE IMPLANTS COULD BE INSPECTED AND SO ARTHREX COULD REPORT THE FINDINGS BACK TO PATIENT. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 7703770 ↗
• InjuryDec 15, 2017Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROSCOPY ON (B)(6) 2015. THE FOLLOWING WAS IMPLANTED: AR-503-TTTH / LOT 1337234, AR-504-PSC9 / LOT 113601511, AR-516-7L / LOT 1373719, AR-513-BH10 / LOT 113601408. THE PATIENT IS ABOUT 20 MONTHS POST-OP AND IS EXPERIENCING TIBIAL LOOSENING. THE REVISION SURGERY IS CURRENTLY PENDING. PATIENT IS A MALE, (B)(6) WEIGHING (B)(6) POUNDS. (B)(6). FOLLOW-UP INVESTIGATION: REVISION SURGERY TOOK PLACE ON (B)(6) 2017. ALL OF THE ARTHREX KNEE COMPONENTS WERE EXPLANTED AND ANOTHER MANUFACTURER'S PRODUCT WAS USED TO COMPLETE THE REVISION SURGERY. REP HAD REQUESTED THAT THE FACILITY RETAIN THE EXPLANTED DEVICES FOR RETURN HOWEVER THEY WERE ACCIDENTALLY DISCARDED AT THE FACILITY. THE REVISION SURGERY WAS PERFORMED BY A DIFFERENT SURGEON THAN THE ORIGINAL SURGERY. THE TWO SURGERIES WERE PERFORMED AT DIFFERENT FACILITIES. WHILE REVIEWING X-RAYS PRIOR TO THE REVISION THE SURGEON HAD STATED TO THE SALES REP THAT THE TIBIAL IMPLANT LOOKED AS THOUGH IT WAS PLACED IN VARUS, WHICH SURGEON BELIEVED WAS THE REASONING FOR THE IMPLANTS LOOSENING.

  Patient problems: No Code Available

  MAUDE report 7123154 ↗
• InjuryJan 18, 2017Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ON (B)(6) 2013 A PATIENT UNDERWENT A BI-LATERAL TKA PROCEDURE. ON (B)(6) 2016 SURGEON PERFORMED A REVISION LEFT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTH, LOT 108761229 ((B)(4)), FEMORAL IMPLANT AR-503-PSLJ, LOT 108761215 ((B)(4)), BEARING IMPLANT AR-503-BH10, LOT 113601229 ((B)(4)) AND PATELLA IMPLANT AR-504-PSD0, LOT 654468 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, (B)(6). MEDICAL RECORDS DATED (B)(6) 2016: FINDINGS LEFT KNEE X-RAY: NO ACUTE FRACTURE, NO ACUTE DISLOCATION, NO LOOSE BODIES NOTED AND PROSTHESIS IN PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING OR STRESS SHIELDING. MEDICAL RECORDS DATED (B)(6) 2016: RECORDS REVEALED EXAMINATION OF THE LEFT KNEE DEMONSTRATED SWELLING. PALPATION OF THE LEFT KNEE DEMONSTRATES INFERIOR POLE PATELLA TENDERNESS AS WELL AS MEDIAL TIBIAL AND LATERAL TIBIAL PLATEAU TENDERNESS. MODERATE EFFUSION OF THE LEFT KNEE WAS NOTED. PATIENT HAD PAIN WITH FLEXION BUT NO PAIN WITH EXTENSION. SURGEON RECOMMENDED A TOTAL LEFT KNEE REVISION DUE TO PAIN IN THE KNEE THAT IS INCREASED WITH ACTI

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

  MAUDE report 6259663 ↗
• InjuryAug 29, 2016Loose or Intermittent Connection

  IT WAS REPORTED THAT ON (B)(6) 2014 A PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION LEFT TKA REPORTEDLY DUE TO LOOSE FEMUR AND TIBIA. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTH (LOT 984546 ) ((B)(4)), FEMORAL IMPLANT AR-503-PSLH (LOT 108761213) ((B)(4)), AND BEARING IMPLANT AR-503-BH12 (LOT 77941245) ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, DOB (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT CONTINUES TO HAVE INCREASED PAIN. EXAMINATION OF THE LEFT KNEE WITH PALPATION DEMONSTRATES MEDIAL JOINT LINE TENDERNESS AND PATELLOFEMORAL REGION TENDERNESS BUT NO LATERAL JOINT LINE TENDERNESS. MILD EFFUSION OF THE LEFT KNEE NOTED. KNEE DEMONSTRATED MILD RETROPATELLAR CREPITUS WITH MOTION.

  Patient problems: No Code Available; Pain

  MAUDE report 5911765 ↗