Arthrex® AR-504-PSC9Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867035560), received between Sep 9, 2016 and Jun 6, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (3 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 11 most recent of 11 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 (B)(6) 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 22161037 ↗
• 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 9272306 ↗
• InjuryOct 18, 2019Appropriate Device Problem Term/Code Not Available

  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 9207325 ↗
• InjuryJun 7, 2018Unstable

  IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION LEFT TKA PROCEDURE DUE TO PATIENT PAIN ((B)(4) MFR REPORT #: 1220246-2016-00295). ON (B)(6) 2017, A DIFFERENT SURGEON PERFORMED A SECOND REVISION DUE TO INSTABILITY. DURING THIS REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-513-T5 (LOT 1003440), FEMORAL IMPLANT AR-516-5L (LOT 1482387), BEARING IMPLANT AR-513-BF-18 (LOT 113601335) AND PATELLA IMPLANT AR-504-PSC9 (LOT 113601511). THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURERS PRODUCT. PATIENT FEMALE, DOB (B)(6).

  Patient problems: Failure of Implant; No Code Available; Pain

  MAUDE report 7580278 ↗
• InjuryOct 27, 2017Loose or Intermittent Connection; Unstable; Improper or Incorrect Procedure or Method

  ON (B)(6) 2017 IT WAS REPORTED VIA THE PATIENT'S ATTORNEY THAT A PATIENT HAD UNDERGONE A REVISION TKA PROCEDURE. IT WAS REPORTED THAT PATIENT'S FIRST ISSUES WITH THE EXPLANTED DEVICE WERE INSTABILITY, PAIN AND MOTION WHICH AROSE IN (B)(6) 2015. AT THE TIME OF INITIAL REPORT THE FOLLOWING ARTHREX PRODUCT WAS INDICATED: AR-503-TTTE, LOT 1206173. NEITHER THE ORIGINAL SURGERY DATE OR REVISION SURGERY DATE WERE PROVIDED DURING INITIAL REPORT. PATIENT DATE OF BIRTH IS (B)(6). ADDITIONAL INFORMATION RECEIVED ON 10/02/2017: ON (B)(6) 2014 PATIENT UNDERWENT A BILATERAL TKA PROCEDURE. PATIENT HAS EXPERIENCED CONSTANT PAIN SINCE ORIGINAL SURGERY. ON (B)(6) 2016 EXAM AND RADIOGRAPHS WERE PERFORMED. ON (B)(6) 2016 SURGEON PERFORMED A REVISION RIGHT TKA DUE TO PAIN AND TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE IBALANCE TKA TIBIAL TRAY, AR-503-TTTE, LOT 1206173 (LINE 206787); IBALANCE PATELLA IMPLANT DOME, AR-504-PSC9, LOT 113601411 (LINE 209438); IBALANCE TKA BEARING, AR-513-BE13, LOT 113601345 (LINE 209440); AND IBALANCE TKA FEMORAL IMPLANT, AR-516-4R, LOT 108761406 (LINE 209441). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT

  Patient problems: Pain; Staphylococcus Aureus

  MAUDE report 6983252 ↗
• InjuryMay 24, 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) 2013 DUE TO RIGHT PATELLAR SUBLUXATION, CHRONIC EFFUSION AND MID-FLEXION LAXITY STATUS THE PATIENT HAD A RIGHT KNEE PROXIMAL REALIGNMENT PATELLA SUBLUXATION PATELLOPLASTY DURING WHICH THE FOLLOWING DEVICES WERE EXPLANTED: BEARING IMPLANT AR-503-BH12, LOT 113601221 AND PATELLA IMPLANT AR-504-PSC9, LOT 113601223. TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PRODUCTS: BEARING IMPLANT AR-503-BH18, LOT 113601222 AND PATELLA IMPLANT AR-504-PSD0, LOT 113601237. PATIENT IS A MALE AND WAS (B)(6)YEARS OF AGE AT TIME OF PROCEDURE. DOB (B)(6) 1953. MEDICAL RECORDS INDICATE PATIENT HAS A BMI OF 35 WHICH IS IN THE OBESE RANGE AND IS CONTRAINDICATED FOR THIS PRODUCT.

  Patient problems: No Code Available

  MAUDE report 6587308 ↗
• InjuryApr 4, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2015 PATIENT UNDERWENT A RIGHT TKA PROCEDURE. PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2016 DURING WHICH THE TIBIAL BEARING WAS EXCHANGED (1220246-2016-00144 / (B)(4)). ON (B)(6) 2017 THE SURGEON PERFORMED A REVISION RIGHT TKA DUE TO PATIENT PAIN. IT WAS REPORTED THAT THE TIBIA WAS NOT LOOSE. DURING THE MARCH 2017 REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTD (LOT 1297049) ((B)(4) (B)(6)), FEMORAL IMPLANT AR-516-4R (LOT 1368092) ((B)(4) (B)(6)), PATELLA IMPLANT AR-504-PSC9 (LOT 113601437) ((B)(4) (B)(6)) AND BEARING IMPLANT AR-513-BD14 (LOT 113601329) ((B)(4) (B)(6)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT IS A FEMALE, DOB (B)(6). THE FOLLOWING WAS OBTAINED FROM THE PATIENT'S MEDICAL RECORDS: RECORDS DATE (B)(6) 2016: PATIENT HAD BEEN DOING WELL UNTIL TRIPPING AND FALLING ONTO A FLEXED KNEE APPROXIMATELY TWO WEEKS PRIOR TO THIS OFFICE VISIT. PATIENT HAS HAD SIGNIFICANT SWELLING SINCE THEN. PATIENT DENIED ANY INSTABILITY. X-RAYS REVIEWED - WELL POSITIONED PROSTHESIS. RECORDS DATED (B)(6) 2016: PATIENT HAS HAD CHRONIC PAIN AND SWELLING SINCE FALLING 7 WEEKS PRIOR WHILE CARRYING A CRATE

  Patient problems: Failure of Implant; Fall; Pain; Swelling

  MAUDE report 6456526 ↗
• InjuryMar 31, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL KNEE PROCEDURE ON (B)(6) 2017 DURING WHICH THE FOLLOWING COMPONENTS WERE IMPLANTED: AR-503-A510 ((B)(4), MEDWATCH 1220246-2017-00103), AR-504-PSC9 ((B)(4) - MEDWATCH 1220246-2017-00104), AR-513-T5 ((B)(4) - MEDWATCH 1220246-2017-00105) AND AR-517-6R ((B)(4) - MEDWATCH 1220246-2017-00106). POST-OP I&D (IRRIGATION AND DEBRIDEMENT) DONE ON (B)(6) 2017, PUS WAS FOUND INSIDE THE KNEE. ALL IMPLANTS WERE EXPLANTED AND REPLACED WITH CEMENT SPACER MIXED WITH ANTIBIOTICS. MALE (B)(6). ADDITIONAL INFORMATION OBTAINED 3/30/17: IT WAS REPORTED THAT ON (B)(6) 2017 PATIENT BEGAN EXPERIENCING MARKED AND SEVERE WELLING AND SPONTANEOUS DRAINING. AT SURGEON OFFICE SAME DAY CULTURES WERE TAKEN AND WERE POSITIVE FOR AN UNSPECIFIED INFECTION DISEASE. ON (B)(6) 2017 PATIENT WENT IN FOR A POST OP I&D AND PUS WAS FOUND INSIDE PATIENT KNEE. DEVICES WERE THEN EXPLANTED. PATIENT WAS KEPT OVERNIGHT AND DISCHARGED (B)(6) 2017. CULTURE/PATHOLOGY WAS PERFORMED DURING REVISION. RESULTS HAVE NOT BEEN PROVIDED. PATIENT IS EXPECTED TO HAVE CEMENT SPACERS LEFT IN 3-6 MONTH, AFTER WHICH SURGEON WILL MOST LIKELY USE ANOTHER MANUFACTURER'S PRODUCT. PATIENT WILL NEED BOTH STEMS

  Patient problems: Purulent Discharge; Swelling; Unspecified Infection

  MAUDE report 6450266 ↗
• InjuryFeb 27, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2015 A PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2017 THE SURGEON PERFORMED A REVISION LEFT TKA DUE TO UNEXPLAINED PAIN AND LOOSE TIBIA. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE (TIBIAL TRAY AR-503-TTTJ, LOT 1251021, ((B)(6) (B)(4)), BEARING IMPLANT AR-513-BJ13, LOT 113601404 ((B)(6) (B)(4)), FEMORAL IMPLANT AR-516-8L, LOT 108761335 ((B)(6) (B)(4)) AND PATELLA IMPLANT AR-504-PSC9, LOT 113601437 ((B)(6) (B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, DOB (B)(6) 1956, WEIGHT (B)(6). PATIENT WAS IN THE OBESE RANGE BY BMI AT THE TIME OF INITIAL WHICH IS CONTRAINDICATED FOR TKA. PATIENT MEDICAL RECORDS DATED 8/9/16 NOTED: LEFT KNEE X-RAY FINDINGS - PROSTHESIS IN PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING OR STRESS SHIELDING. RECORDS NOTED PATIENT WOULD START WEIGHT LOSS PROGRAM TO SEE IF IT WOULD MAKE ANY DIFFERENCE. PATIENT MEDICAL RECORDS DATE (B)(6) 2016 NOTED: PATIENT HAD A I&D OF HEMATOMA (B)(6) 2015. PATIENT HAS HAD EMBOLIZATIONS X3, PATIENT WAS NOTED TO HAVE DECREASED MOBILITY, PAIN WITH SLEEPING, WALKING, STAIRS AND ALL WEIGHT BEARING ACTIVITIES. EX

  Patient problems: Ambulation or Postural Difficulties; Embolism; Hematoma; Limited Mobility Of The Implanted Joint; Pain; Swelling

  MAUDE report 6360437 ↗
• InjuryJan 18, 2017Failure To Adhere Or Bond; Nonstandard Device; Noise, Audible

  IT WAS REPORTED BY A PATIENT THAT SHE HAD UNDERGONE A LEFT TKA PROCEDURE ON (B)(6) 2015. PATIENT STATES THAT ALMOST IMMEDIATELY AFTER THE SURGERY, WITHIN WEEKS, THE PATIENT BEGAN TO HAVE PROBLEMS WITH SWELLING WHICH REQUIRED DRAINING SEVERAL TIMES. PATIENT STATES THERAPY WAS VERY DIFFICULT WITH HER JOINT CONTINUALLY POPPING OUT OF PLACE AND SHE WAS EXPERIENCING A POPPING SOUND. PATIENT SOUGHT A SECOND OPINION AND THE SECOND SURGEON CONCLUDED THAT THE JOINT WAS LOOSE AND WOULD NEED TO BE REPLACED. SURGEON RECOMMENDED WAITING A YEAR FROM ORIGINAL SURGERY TO ALLOW HER BODY TO HEAL. ON (B)(6) 2016 PATIENT UNDERWENT A REVISION LEFT TKA PROCEDURE AT A DIFFERENT FACILITY, PERFORMED BY THE SECOND OPINION SURGEON. DURING THE REVISION SURGERY THE NEW SURGEON EXPLANTED THE FOLLOWING ARTHREX PRODUCTS: TIBIAL TRAY, AR-503-TTTE, LOT 1191338 (CC102620 LINE 178606), FEMORAL IMPLANT, AR-516-4L, LOT 108761334 (CC102620 LINE 178609), BEARING IMPLANT, AR-513-BE12, LOT 113601433 (CC102620 LINE 178610) AND PATELLA IMPLANT, AR-504-PSC9, LOT 113601324 (CC102620 LINE 178611). THE NEW SURGEON COMPLETED THE PROCEDURE USING ANOTHER MANUFACTURER'S PRODUCT. PATIENT HAD CALLED THE FDA AND WAS INSTRUCTED TO CONTA

  Patient problems: Joint Dislocation; Swelling

  MAUDE report 6259673 ↗
• InjurySep 9, 2016Device Slipped; Unstable

  IT WAS REPORTED THAT ON (B)(6) 2013, A 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-503-TTTE (LOT 108761229)((B)(6)), FEMORAL IMPLANT AR-503-PSLF (LOT 108761212) ((B)(6)), BEARING IMPLANT AR-503-BE12 (LOT 113601237) ((B)(6)) AND PATELLA IMPLANT AR-504-PSC9 (LOT 113601237) ((B)(6)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE, DOB (B)(6) 1961. MEDICAL RECORDS DATED (B)(6) 2016 NOTED THE FOLLOWING: PATIENT HAVING PAIN AND A GRINDING SENSATION UNDER KNEECAP WHEN WALKING. PATIENT ALSO NOTED THE KNEE FEELS LOOSE AND UNSTABLE. EXAMINATION OF THE LEFT KNEE WITH PALPATION DEMONSTRATED MEDIAL JOINT LINE AND PATELLOFEMORAL REGION TENDERNESS BUT NO LATERAL JOINT LINE TENDERNESS. TRACE EFFUSION OF THE LEFT KNEE WAS NOTED. RECORDS NOTED PATIENT HAS PAIN THROUGH A LIMITED PASSIVE RANGE OF MOTION WITH CREPITUS AND SWELLING. MEDICAL RECORDS ALSO NOTED X-RAYS SHOWED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING.

  Patient problems: Loss of Range of Motion; Pain; Tissue Damage

  MAUDE report 5940749 ↗