Arthrex® AR-504-PSD0Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867035577), received between Dec 2, 2016 and May 18, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2021Appropriate 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 11841713 ↗
• InjuryDec 12, 2019Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED BY THE PATIENT THAT HE HAD TOTAL KNEE RECONSTRUCTION ON 4-22-15. 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 SCHEDULED ON

  Patient problems: Pain

  MAUDE report 9457417 ↗
• InjurySep 6, 2019Unstable; Appropriate Device Problem Term/Code Not Available; Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2018 IT WAS REPORTED BY THE PATIENT, VIA THE ARTHREX WEBSITE, THAT HE UNDERWENT A BILATERAL TKA PROCEDURE ON (B)(6) 2013. TWO YEARS AFTER THE INITIAL SURGERY THE PATIENT BEGAN HAVING INSTABILITY AND PAIN IN BOTH KNEES (CC138269). ON (B)(6) 2018 A REVISION LEFT TKA PROCEDURE WAS PERFORMED BY THE SAME SURGEON DUE TO TIBIAL LOOSENING. ((B)(4), WHICH WAS REPORTED ON MEDWATCH 1220246-2018-00556). IT HAS NOW BEEN REPORTED THAT THE PATIENT HAD A RIGHT TKA REVISION ON (B)(6) 2019 BY THE SAME SURGEON AT A DIFFERENT FACILITY USING ANOTHER MANUFACTURER¿S PRODUCT. THE REVISION WAS PERFORMED DUE TO TIBIAL LOOSENING AND PAIN. THE ORIGINAL ARTHREX RIGHT TKA DEVICES WERE EXPLANTED AND THE PATIENT REQUESTED THEY BE RETURNED TO ARTHREX FOR EVALUATION. ARTHREX HAS NOT RECEIVED THE IMPLANTS TO DATE. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE (B)(6) 2019 REVISION: AR-503-TTTH, TIBIAL TRAY (LOT 108761238), AR-503-PSRJ FEMORAL IMPLANT (LOT 108761219), AR-503-BH10 BEARING IMPLANT (LOT 113601221), AR-504-PSD0 PATELLA IMPLANT (LOT 654468).

  Patient problems: Failure of Implant; Pain

  MAUDE report 8970733 ↗
• 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 8748848 ↗
• 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 9/21/2018: 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 TO PROV

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

  MAUDE report 7943603 ↗
• InjuryJul 19, 2018Loose or Intermittent Connection; Unstable

  IT WAS INITIALLY REPORTED BY PATIENT THROUGH THE ARTHREX WEBSITE, THAT THE PATIENT HAD TOTAL KNEE REPLACEMENT PROCEDURE ON BOTH KNEES USING ARTHREX PRODUCTS. (INITIAL REPORT REFERENCE (B)(4)) PATIENT PROVIDED THE FOLLOWING INFORMATION (B)(6) 2018: 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 DEVI

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 7703839 ↗
• InjuryDec 2, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2014, A PATIENT UNDERWENT A LEFT TKA PROCEDURE (DURING WHICH TIME THE PATELLA WAS NOT RESURFACED). ON (B)(6) 2015, THE PATIENT UNDERWENT A LEFT BEARING EXCHANGE/PATELLOPLASTY PROCEDURE ((B)(6)). ON (B)(6) 2016 ,THE SURGEON PERFORMED A LEFT TKA REVISION DUE TO TIBIAL LOOSENING AND PATIENT PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE FOLLOWING COMPONENTS: TIBIAL TRAY AR-503-TTTE, LOT 108761203 ((B)(6)), FEMORAL IMPLANT AR-503-PSLF, LOT 108761213 ((B)(6)), BEARING IMPLANT AR-513-BE14, LOT 113601330A ((B)(6)) AND PATELLA IMPLANT AR-504-PSD0, LOT 113601415 ((B)(6)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, DOB (B)(6) 1956. PATIENT MEDICAL RECORDS DATE (B)(6) 2016 NOTED: FINDINGS LEFT KNEE X-RAY SHOWED PROSTHESIS IN PLACE, IN PROPER ANATOMICAL ALIGNMENT, WITHOUT ROTATION, LOOSENING OR STRESS SHIELDING. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED: EXAMINATION OF THE LEFT KNEE DEMONSTRATES MEDIAL JOINT LINE TENDERNESS AND LATERAL JOINT LINE TENDERNESS. MILD EFFUSION OF THE LEFT KNEE WAS NOTED. PATIENT WAS UNSTABLE TO VALGUS STRESS AT 30 DEGREES FLEXION. RECORDS NOTED SURGEON RECOMMENDE

  Patient problems: Increased Sensitivity; Pain; Swelling

  MAUDE report 6142646 ↗