Arthrex® AR-503-TTTJRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867106765), received between Jul 8, 2016 and Jul 1, 2019 — classified as 9 injuries.

The most frequently reported specific device problem is “Unstable” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2019Loose or Intermittent Connection

  IT WAS REPORTED VIA THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT HAD UNDERGONE A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-503-TTTJ, TIBIAL IMPLANT, LOT 108761234. AR-503-PSRJ, FEMORAL IMPLANT, LOT 108761219. AR-503-BJ12, BEARING IMPLANT, LOT 113601230. AR-504-PSD0, PATELLA IMPLANT, LOT 113601225. THE PATIENT UNDERWENT A REVISION RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2018 DUE TO PAINFUL, LOOSE RIGHT TOTAL KNEE ARTHROPLASTY. DURING THE PROCEDURE THE ARTHREX IMPLANTS WERE REMOVED AND ANOTHER MANUFACTURER'S PRODUCTS WERE IMPLANTED. THE REVISION OPERATIVE REPORT FINDINGS NOTED THAT THE TIBIAL AND PATELLAR COMPONENTS WERE GROSSLY LOOSE AND THE FEMORAL COMPONENT WAS POORLY FIXED. THE INDEX AND REVISION SURGERIES WERE PERFORMED BY DIFFERENT SURGEONS AT DIFFERENT LOCATIONS. THE EXPLANTED DEVICES WERE NOT RETURNED FOR INSPECTION AND THE DISPOSITION IS UNKNOWN AT THIS TIME.

  Patient problems: Failure of Implant; Pain

  MAUDE report 8748838 ↗
• InjuryMay 11, 2018Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED AT THE TIME OF PROCEDURE:AR-503-TTTJ TIBIAL TRAY LOT 108761232;AR-513-BJ08 TIBIAL BEARING LOT 113401345;AR-516-8R FEMORAL IMPLANT LOT 108761339;AR-504-PSD0 PATELLA IMPLANT LOT 113601323.ON (B)(6) 2015, THE PATIENT HAD A FOLLOW UP VISIT WITH THE ORIGINAL SURGEON WITH COMPLAINTS OF SWELLING AND PAIN IN THE RIGHT KNEE. RADIOGRAPHS WERE TAKEN THEY SHOWED THE TIBIAL POLY INSERT WAS DISLODGED. THE SURGEON INFORMED THE PATIENT IT COULD TAKE UP TO SIX MONTHS TO HEAL AND REQUESTED HE FOLLOW UP IN THREE MONTHS. THE PATIENT RETURNED TO THE ORIGINAL SURGEON ON (B)(6) 2015. X-RAYS WERE TAKEN AND REVEALED THAT THE POLY-INSERT WAS 50% SUBLUXED ANTERIORLY AND HAD PROGRESSIVELY MIGRATED OVER THE PAST SEVERAL MONTHS. THE SURGEON BELIEVED THAT THE LOCKING MECHANISM OF THE POLYETHYLENE WAS NOT ENGAGED. THE SURGEON RECOMMENDED PERFORMING A POLY-INSERT EXCHANGE. ON (B)(6) 2015, THE PATIENT SOUGHT A SECOND OPINION FROM A DIFFERENT SURGEON. THE NEW SURGEON RECOMMENDED A TOTAL REVISION OF THE RIGHT KNEE DUE TO THE ORIGINAL SURGEON'S IMPROPER SIZIN

  Patient problems: Pain; Swelling

  MAUDE report 7506201 ↗
• InjuryMay 24, 2017Unstable; Malposition of Device

  IT WAS REPORTED THAT ON (B)(6) 2014 A PATIENT HAD A RIGHT TKA PROCEDURE. ON (B)(6) 2017 A DIFFERENT SURGEON PERFORMED A REVISION RIGHT TKA PROCEDURE. DURING THE REVISION THE FOLLOWING DEVICES WERE EXPLANTED: TIBIAL TRAY AR-503-TTTC, LOT 108761313, FEMORAL IMPLANT AR-503-PSRD, LOT 108761217-LINE (B)(6) AND BEARING IMPLANT AR-503-BC10, LOT 113601232- LINE (B)(6). THE PATELLA DOME AR-504-PSB8, LOT 113601322 FROM THE ORIGINAL (B)(6) 2014 SURGERY WAS RETAINED AND NOT EXPLANTED. TO COMPLETE THE PROCEDURE ANOTHER MANUFACTURER'S PRODUCTS WERE IMPLANTED. PATIENT IS A FEMALE, DOB (B)(6), AGE AT TIME OF REVISION WAS (B)(6). MEDICAL RECORDS DATED (B)(6) 2016 NOTE: TOTAL RIGHT KNEE PROSTHESIS POSITION REMAINS SATISFACTORY AND UNCHANGED. NO FINDINGS SUGGESTIVE OF PROSTHESIS LOOSENING ARE SEEN. MEDICAL RECORDS DATED (B)(6) 2017 NOTE: X-RAY OF THE RIGHT KNEE DEMONSTRATES A CEMENTED TIBIAL COMPONENT WITH NO RADIOLUCENT LINE. A CEMENTED FEMORAL COMPONENT WITH NO RADIOLUCENT LINE. NO GROSS EVIDENCE OF POLYETHYLENE WEAR. NO EVIDENCE OF OSTEOLYSIS IN THE FEMORAL BONE STOCK. NO GROSS EVIDENCE OF LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS. OPERATIVE REPORT DATED (B)(6) 2017 NOTE: PREOPERATIVE DIAGNOS

  Patient problems: No Code Available

  MAUDE report 6587277 ↗
• InjuryMay 23, 2017Unstable; Failure to Align; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) 2015 A PATIENT HAD A RIGHT TKA PROCEDURE. A NEW SURGEON PERFORMED A REVISION TKA ON (B)(6) 2016. PRE-OPERATIVE DIAGNOSIS WAS MALALIGNMENT OF THE FEMORAL COMPONENT OF THE RIGHT TOTAL KNEE REPLACEMENT WITH RECURRING INSTABILITY AND DISLOCATION OF THE RIGHT PATELLA AND PATELLAR COMPONENT. REVISION OPERATIVE REPORT NOTED THAT PATELLA WAS CHRONICALLY DISLOCATED ON X-RAY AND THE FEMORAL COMPONENT WAS FIXED IN 10 DEGREES OF VALGUS WHICH ALSO PREDISPOSED PATIENT FOR DISLOCATE ABILITY OF THE PATELLAR BONE AND EXTENSOR MECHANISM. THE TIBIAL COMPONENT WAS NOTED TO BE WELL FIXED AND ALIGNED. DURING THE REVISION PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: TIBIAL TRAY AR-503-TTTH, LOT 1206181, FEMORAL IMPLANT AR-516-7R, LOT 108761338, BEARING IMPLANT AR-513-BH12, LOT 113601409 AND PATELLA IMPLANT AR-504-PSC9, LOT 113601437. MEDICAL RECORDS INDICATE PATIENT HAS A BMI OF (B)(6) WHICH IS IN THE OBESE RANGE AND IS CONTRAINDICATED FOR THIS PRODUCT.

  Patient problems: No Code Available

  MAUDE report 6584636 ↗
• InjuryMar 15, 2017Loose or Intermittent Connection; Unstable

  IT WAS REPORTED THAT ON (B)(6) 2013 A PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2017 THE SURGEON PERFORMED A REVISION LEFT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION SURGERY THE SURGEON EXPLANTED THE FOLLOWING ARTHREX PARTS: TIBIAL TRAY, AR-503-TTTJ, LOT 108761234, FEMORAL IMPLANT, AR-503-PSLJ, LOT 108761211, BEARING IMPLANT, AR-503-BJ18, LOT 113601221 AND PATELLA IMPLANT, AR-504-PSD0, LOT 113601237. THE REVISION PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURERS PRODUCT. THE FOLLOWING HAS BEEN OBTAINED FROM PATIENT MEDICAL RECORDS: RECORDS DATED (B)(6) 2014: AP AND LATERAL X-RAYS OF LEFT KNEE IDENTIFIED A WELL PLACED TOTAL KNEE PROSTHESIS IN GOOD ANATOMIC ALIGNMENT, WITHOUT SIGNS OF LOOSENING, FRACTURE, INFECTION OR OTHER ABNORMALITIES. RECORDS DATED (B)(6) 2014: LARGE EFFUSION OF LEFT KNEE, RANGE OF MOTION EXAMINATION OF LEFT KNEE DEMONSTRATED MINOR CREPITUS WITH MOTION. LEFT KNEE ASPIRATED AND INJECTED. RECORDS DATED (B)(6) 2014: PALPATION OF THE LEFT KNEE DEMONSTRATED PATELLOFEMORAL REGION TENDERNESS, BUT NO MEDIAL OR LATERAL JOINT LINE TENDERNESS. MILD EFFUSION OF LEFT KNEE. PRIOR AUGUST 2014 ASPIRATION RESULTS OF FLUID TESTING WERE NEGATIVE. RECORDS DATED (B)(6

  Patient problems: Failure of Implant; Joint Swelling; Pain

  MAUDE report 6405441 ↗
• InjuryMar 14, 2017Device Slipped

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TKA PROCEDURE ON (B)(6) 2014 DURING WHICH THE PATELLA WAS NOT RESURFACED. THE SURGEON PERFORMED A REVISION RIGHT TKA ON (B)(6) 2017 DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE FOLLOWING ARTHREX PRODUCTS: TIBIAL TRAY, AR-503-TTTJ, LOT 108761232, FEMORAL IMPLANT, AR-503-PSRJ, LOT 108761216, AND BEARING IMPLANT, AR-503-BJ18, LOT 113601221. THE REVISION PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S PRODUCT. IT HAS BEEN REPORTED THAT THE SURGEON CHOSE NOT TO REQUEST PATIENT AUTHORIZATION TO RETURN EXPLANTS FOR EVALUATION AND THE EXPLANTS WERE DISCARDED AT THE TIME OF SURGERY. ADDITIONAL INFORMATION OBTAINED FROM PATIENT MEDICAL RECORDS: RECORDS DATED (B)(6) 2015: RECORDS NOTED PATIENT ALSO HAS A HISTORY OF GASTRIC BYPASS SURGERY FOR MORBID OBESITY. RECORDS DATED (B)(6) 2015: RECORDS NOTED PATIENT WAS OBESE AT (B)(6) LBS (WHICH IS A CONTRAINDICATION FOR TKA - PATIENT'S WEIGHT AT THE TIME OF (B)(6) 2014 SURGERY IS UNKNOWN). RECORDS DATED (B)(6) 2016: X-RAY FINDINGS RIGHT KNEE -PROSTHESIS IN PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING OR STRESS SHIELDING. X-RAYS SHOW PERIARTICULAR OS

  Patient problems: Fall; Joint Swelling; Weight Changes

  MAUDE report 6401992 ↗
• InjuryOct 10, 2016Failure To Adhere Or Bond

  IT WAS REPORTED THAT ON (B)(6) 2013 A PATIENT UNDERWENT A RIGHT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION RIGHT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR- 503-TTTJ LOT 108761234 ((B)(4)), FEMORAL IMPLANT AR-503-PSRJ LOT 108761219 ((B)(4)), BEARING IMPLANT AR-503-BJ15 LOT 113601221 ((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). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED THE FOLLOWING: PATIENT CONTINUED TO HAVE CHRONIC RIGHT KNEE PAIN AND SWELLING. EXAMINATION OF THE RIGHT KNEE DEMONSTRATED WARMTH AND SWELLING. PALPATION OF THE RIGHT KNEE DEMONSTRATED MEDIAL JOINT LINE TENDERNESS BUT NO LATERAL JOINT LINE TENDERNESS. MODERATE EFFUSION OF THE RIGHT KNEE WAS ALSO NOTED. REPORT SUMMARY NOTED THE X-RAYS SHOWED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING.

  Patient problems: Pain; Palpitations; Swelling

  MAUDE report 6015406 ↗
• InjuryAug 5, 2016Break; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2015, PATIENT UNDERWENT A RIGHT TKA PROCEDURE. ON (B)(6) 2016 SURGEON PERFORMED A REVISION RIGHT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTJ (LOT 1191341)((B)(4)), AND BEARING IMPLANT AR-513-BJ14 (LOT 113601408)((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PARTS: TIBIAL TRAY AR-513-T8 (LOT 10019689), BEARING IMPLANT AR-513-BJ20 (LOT 113601407) AND STEM EXTENSION IMPLANT AR-513-1450 (LOT 10024348). PATIENT WAS A MALE, (B)(6), DOB (B)(6). DURING THE REVISION THE SURGEON WAS USING A AR-613-1 ((B)(4)), UNIVERSAL HANDLE, LOT 1391544 FOR THE REMOVAL OF THE TIBIAL PUNCH HEAD. THE PUNCH HEAD WAS ABLE TO BE REMOVED BUT THE HANDLE BROKE IN THE PROCESS. ALSO BEING USED WAS AN AR-623-3 ((B)(4)), IBALANCE TKA T2 TORQUE DRIVER, LOT 221522. THE DEVICE WAS USED TO COMPLETE THE TIGHTENING OF THE STEM EXTENSION LOCKING SCREW BUT IN THE PROCESS THE DEVICE TIP BROKE. ALL BROKEN PIECES FULLY RETRIEVED. BROKEN DEVICES ARE BEING RETURNED FOR EVALUATION. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT HAD BEEN DOING WELL UNTIL 1 1/2 WEEKS PRIOR TO VISIT. AT THAT TIME PA

  Patient problems: Joint Swelling; Loss of Range of Motion; Pain

  MAUDE report 5849925 ↗
• InjuryJul 8, 2016Failure To Adhere Or Bond

  IT WAS REPORTED THAT ON (B)(6) 2013, PATIENT UNDERWENT A LEFT 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-TTTJ (LOT 108761220), FEMORAL IMPLANT AR-503-PSLJ (LOT 108761211), BEARING IMPLANT AR-503-BJ10 (LOT 113601230) AND PATELLA IMPLANT AR-504-PSD0 (LOT 654468). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT, MALE, (B)(6). PATIENT MEDICAL RECORDS OF (B)(6) 2016 NOTED PATIENT WAS COMPLAINING OF PERSISTENT LEFT KNEE PAIN, PRIMARILY WITH WALKING AND DESCENDING STAIRS. EXAMINATION OF LEFT KNEE DEMONSTRATED WARMTH AND SWELLING, PALPATION OF THE LEFT KNEE DEMONSTRATED MEDIAL JOINT LINE TENDERNESS AND MEDIAL TIBIAL PLATEAU TENDERNESS, BUT NO LATERAL JOINT LINE TENDERNESS. RECORDS NOTED NO PAIN WITH FLEXION OR EXTENSION. EXAMINATION TESTS INDICATED UNSTABLE TO VARUS STRESS AT 30 DEGREES FLEXION, BUT A NEGATIVE ANTERIOR DRAWER SIGN, A NEGATIVE POSTERIOR DRAWER SIGN AND STABLE TO VALGUS STRESS AT 30 DEGREES FLEXION. PRIOR TO EXAMINATION ON (B)(6) 2016 PATIENT HAD BEEN SENT FOR A CT SCAN. RECORDS NOTED X-RAYS SHOWED PERIARTICULAR OSTEO

  Patient problems: Pain; Palpitations; Swelling

  MAUDE report 5778268 ↗