Arthrex® AR-504-PSB8Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867035553), received between Aug 29, 2016 and Sep 18, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A PATIENT VIA PHONE THAT THE PATIENT HAD SURGERY ON (B)(6) 2018 FOR A RIGHT KNEE PATELLOFEMORAL JOINT REPLACEMENT. AFTER THE SURGERY, THE PATIENT EXPERIENCED PAIN WHEN LYING DOWN AND LATER ON EXPERIENCED SHARP PAIN IN THE BACK OF THE LEG WHEN GOING UP THE STAIRS WITH THE PATIENT'S LEG GIVING OUT. AN X-RAY WAS PERFORMED AFTERWARD AND SHOWED THAT THE UNKNOWN ARTHREX PART NUMBER THAT WAS IMPLANTED ON (B)(6) 2018 HAD COME APART/BROKEN. PER THE PATIENT, THE SURGEON STATED THIS WAS NOT NORMAL AND PERFORMED AN ARTHROPLASTY TOTAL REVISION SURGERY ON THE RIGHT KNEE ON (B)(6) 2024 TO REMOVE THE BROKEN PART AND PUT A NEW PART IN. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEON AT DIFFERENT FACILITIES. ADDITIONAL INFORMATION RECEIVED ON 9/5/2024: THE MEDICAL RECORDS INDICATE THAT THE PATIENT DID WELL FOLLOWING HIS 2018 SURGERY UNTIL HE FIRST EXPERIENCED RIGHT POSTERIOR KNEE PAIN ABOUT A YEAR AGO. THE PATIENT REPORTED THAT THERE WAS NO PRECEDING INJURY OR TRAUMA. THE PATIENT BELIEVES THE PAIN BEGAN SHORTLY AFTER RECEIVING STEM CELL INJECTIONS ON THE RIGHT FOOT. THE PATIENT'S SYMPTOMS WORSENED ON (B)(6) 2024 THE PATIENT EXPERIENCED SHARP PAIN IN THE BACK OF T

  Patient problems: Failure of Implant; Implant Pain; Joint effusion; Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 20248464 ↗
• InjuryNov 25, 2019Loose or Intermittent Connection; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT TKA PROCEDURE ON (B)(6) 2013. DURING THIS PROCEDURE THE FOLLOWING DEVICES WERE IMPLANTED: AR-503-TTTE (LOT 108761149), AR-503-PSLE, FEMORAL IMPLANT (LOT 108761204), AR-503-BE09, BEARING IMPLANT (LOT 654422), AR-504-PSB8, PATELLA IMPLANT (LOT 654465). ALMOST IMMEDIATELY AFTER THE SURGERY THE PATIENT BEGAN EXPERIENCING PAIN AND A CLICKING/CRUNCHING SOUND IN HER KNEE. THE PATIENT REPORTED SHE FOLLOWED ALL POST-SURGERY ORDERS AND PERFORMED ALL THE PHYSICAL THERAPY AS ORDERED. DURING THE COURSE OF THE FIRST YEAR AFTER THE TKA PROCEDURE, THE SURGEON HAD TO DRAIN FLUID FROM THE PATIENT¿S KNEE THREE OR FOUR TIMES. THE PATIENT CONTINUED TO EXPERIENCE PAIN AND THE CLICKING/CRUNCHING SOUND. ON (B)(6) 2014, THE ORIGINAL TKA SURGEON PERFORMED A PROCEDURE TO CLEAN OUT THE SCAR TISSUE FROM THE PATIENT¿S JOINT. THE PATIENT¿S ISSUES STILL PERSISTED. SINCE THE SCAR TISSUE REMOVAL PROCEDURE, THE PATIENT HAD A BONE SCAN THAT INDICATED THE KNEE JOINT HAD AN INFECTION IN THE JOINT/BONE/TISSUE OR AN IMPLANT WAS LOOSE. ACCORDING TO THE PATIENT THE ORIGINAL TKA SURGEON WAS NOT ALARMED OR CONCERNED BY THE BONE SCAN FINDINGS AND INFORMED HER THAT THE KNEE WAS

  Patient problems: Pain; Unspecified Infection

  MAUDE report 9369117 ↗
• InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS ORIGINALLY REPORTED ((B)(4)) BY PATIENT'S ATTORNEY THAT PATIENT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2015 DURING WHICH THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-503-TTTE, TIBIAL TRAY, LOT 1315453. AR-516-5L, FEMORAL IMPLANT, LOT 1476178. AR-513-BE12, TIBIAL BEARING, LOT 113601433. AR-504-PSB8, PATELLA IMPLANT, LOT 113601439. SURGEON OFFICE RECORDS (B)(6) 2016: PATIENT STILL HAS SOME RESIDUAL STIFFNESS AND MILD DISCOMFORT. PATIENT REPORTED OLD PAIN IS GONE, PAIN IS BETTER THAN BEFORE SURGERY. PATIENT HAS PAIN ON AND OFF IN TIBIAL REGION AND REPORTED KNEE WILL SWELL ON OCCASION. SURGEON OFFICE RECORDS (B)(6) 2017: PATIENT REPORTED PAIN IN BOTH KNEES AND PAIN WITH WALKING IN BOTH KNEES. PATIENT REPORTED RIGHT KNEE HURTS MORE THAN LEFT KNEE. PATIENT DID NOT IMPROVE WITH STEROID INJECTIONS. ADDITIONAL INFORMATION OBTAINED (B)(6) 2018: PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 DUE TO PAINFUL LEFT TOTAL KNEE ARTHROPLASTY, MORBID OBESITY. OPERATIVE REPORT (B)(6) 2018: ALL ORIGINAL COMPONENTS WERE EXPLANTED. BEARING WAS REMOVED WITH COMPRESSION OF THE TIBIA. THE FEMUR WAS FOUND TO BE WELL FIXED. FEMUR AND PATELLA REQUIRED OSTEOTOMES AND/OR OSC

  Patient problems: Discomfort; Pain; Patient Problem/Medical Problem; Swelling

  MAUDE report 8117015 ↗
• InjuryAug 29, 2016Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2014 A PATIENT UNDERWENT A RIGHT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION RIGHT TKA DUE TO PATIENT PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTD (LOT 108761205)((B)(4)), BEARING IMPLANT AR-503-BD12 (LOT 77941235)((B)(4)) AND PATELLA IMPLANT AR-504-PSB8 (LOT 113601322)((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PRODUCTS: TIBIAL TRAY AR-513-T3 (LOT 10029431), BEARING IMPLANT AR-513-BD18 (LOT 113601330) AND PATELLA IMPLANT AR-504-PSD0 (LOT 113601430). PATIENT WAS A FEMALE, DOB (B)(6) 1963. EXPLANTED PARTS WERE DISCARDED BY THE FACILITY. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT HAD A BONE SCAN WHICH SOWS UPTAKE CONSISTENT WITH LOOSENING IN MTP. PAST ASPIRATION AND INJECTION PROVIDED LITTLE RELIEF. FLUID HAD BEEN SENT FOR CULTURES AND WAS NEGATIVE FOR INFECTION. PATIENT HAS PAIN AT NIGHT IN MTP REGION AND PAIN WITH DAILY ACTIVITIES, WALKING, STAIRS. PAIN DAILY. RECORDS NOTED A JOLT WAS FELT IN MTP REGION OF KNEE. PATIENT HAS SOME GIVING WAY OF KNEE AND INSTABILITY. EXAMINATION WITH PALPATION DEMONSTRATED MEDIAL JOINT LINE TENDERNESS AND MEDIAL T

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 5911797 ↗