Arthrex® AR-503-TTTERecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867106727), received between Jul 26, 2016 and Nov 25, 2019 — classified as 14 injuries.

The most frequently reported specific device problem is “Nonstandard Device” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2019Loose or Intermittent Connection; Microbial Contamination of Device; 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: Failure of Implant; Pain; Scar Tissue; Unspecified Infection

  MAUDE report 9369093 ↗
• InjuryAug 16, 2019Loose or Intermittent Connection; Nonstandard Device

  IT WAS REPORTED VIA THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2015. DURING THE 2015 PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: AR-503-TTTE TIBIAL TRAY IMPLANT (LOT 1315454), AR-517-5R FEMORAL IMPLANT (LOT 1438474), AR-503-A409 BEARING IMPLANT (LOT 113601322), AR-504-PSB8 PATELLA IMPLANT (LOT 113601439). IT WAS REPORTED THAT PATIENT FAILED TO RESPOND TO CONSERVATIVE TREATMENT, WAS EXPERIENCING PERSISTENT PAIN AND HAD A BONE SCAN THAT DEMONSTRATED LOOSENING OF THE TIBIAL COMPONENT. AS A RESULT, THE PATIENT UNDERWENT A REVISION RIGHT TOTAL KNEE ARTHROPLASTY WITH A STEMMED TIBIAL COMPONENT ON (B)(6) 2017. THE (B)(6) 2017 OPERATIVE REPORT NOTED THAT THE FEMORAL COMPONENT WAS WELL FIXED AS WAS THE PATELLAR COMPONENT. THE TIBIAL COMPONENT WAS REMOVED WITH THE COMBINATION OF A GIGLI SAW AND AN OSCILLATING MOTORIZED SAW AND WAS NOTED TO BE LOOSE. THE REVISION WAS COMPLETED USING A STEMMED TIBIAL COMPONENT. BOTH PROCEDURES WERE PERFORMED BY THE SAME SURGEON AT THE SAME FACILITY.

  Patient problems: Pain

  MAUDE report 8903017 ↗
• InjuryNov 29, 2018Nonstandard Device; Patient-Device Incompatibility

  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: Pain; Swelling

  MAUDE report 8116971 ↗
• InjurySep 4, 2018Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED VIA THE PATIENT'S ATTORNEY THAT A PATIENT HAD AN ORIGINAL BI-LATERAL TKA PROCEDURE ON (B)(6) 2014. ON (B)(6) 2016 PATIENT UNDERWENT A REVISION RIGHT TKA (ARTHREX REFERENCE # (B)(4) MEDWATCH 1220246-2017-00400). ON (B)(6) 2018 PATIENT UNDERWENT A REVISION LEFT TKA DURING WHICH THE ORIGINAL ARTHREX IMPLANTS BELOW WERE EXPLANTED: AR-503-TTTE, LOT 1206173, TIBIAL TRAY IMPLANT; AR-516-4L, LOT 108761402, FEMORAL IMPLANT; AR-513-BE13, LOT 113601414, TIBIAL BEARING IMPLANT; AR-504-PSC9, LOT 113601411, PATELLA IMPLANT. PER ARTHREX COMPLAINT REFERENCE (B)(4), MEDICAL RECORDS DATED (B)(6) 2015 NOTE "SHE HAD FALLEN WHEN VISITING HER DAUGHTER (B)(6) AND HAD SURGERY THAT NIGHT FOR EXTERNAL ROTATION OF THE RIGHT FIB." MEDICAL RECORDS ALSO NOTED PATIENT HAD A BMI OF APPROX.(B)(6) WHICH IS CONTRAINDICATED FOR THIS DEVICE. INFORMATION OBTAINED FROM (B)(6) 2018 OP REPORT: REVISION PRE AND POST OPERATIVE DIAGNOSIS WAS LOOSENING OF TIBIAL COMPONENT. THE TIBIAL COMPONENT WAS COMPLETELY LOOSE. THERE WAS NO ASPECT OF CEMENT THAT ADHERED TO THE TIBIA COMPONENT. ALTERNATIVELY THE CEMENT WAS FIXATED TO THE TIBIA BONE. REVISION PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S TKA DEVICES.

  Patient problems: Fall; Injury

  MAUDE report 7841425 ↗
• InjuryOct 27, 2017Nonstandard Device; Device Slipped; Unstable

  ON 9/12/2017 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. (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 ((B)(4)); IBALANCE PATELLA IMPLANT DOME, AR-504-PSC9, LOT 113601411 ((B)(4)); IBALANCE TKA BEARING, AR-513-BE13, LOT 113601345 ((B)(4)); AND IBALANCE TKA FEMORAL IMPLANT, AR-516-4R, LOT 108761406 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE. ADDITIONAL INFORMATION RECEIVED O

  Patient problems: Fall; Pain

  MAUDE report 6983248 ↗
• InjuryMay 22, 2017Loose or Intermittent Connection; Nonstandard Device

  IT WAS REPORTED THAT ON (B)(6) 2015 A PATIENT HAD UNDERGONE A TKA PROCEDURE DURING WHICH THE PATELLA WAS NOT RESURFACED. ON (B)(6) 2017 THE SURGEON PERFORMED A REVISION TKA DUE TO TIBIAL LOOSENING AND PAIN. DURING THE REVISION THE FOLLOWING DEVICES WERE EXPLANTED: TIBIAL TRAY, AR-503-TTTE, LOT 1315462, FEMORAL IMPLANT, AR-516-5R, LOT 108761425 AND BEARING IMPLANT, AR-513-BE09, LOT 113601402. THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURER'S PRODUCT. THE OPERATIVE REPORTS AND MEDICAL RECORDS INDICATE PATIENT IS MORBIDLY OBESE (BMI OF (B)(6)) WHICH IS CONTRAINDICATED FOR THIS PRODUCT.

  Patient problems: No Code Available; Pain

  MAUDE report 6581002 ↗
• InjuryFeb 27, 2017Nonstandard Device; Device Slipped

  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)), BEARING IMPLANT AR-513-BJ13, LOT 113601404 ((B)(6)), FEMORAL IMPLANT AR-516-8L, LOT 108761335 ((B)(6)) AND PATELLA IMPLANT AR-504-PSC9, LOT 113601437 ((B)(6)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, DOB (B)(6) 1956. PATIENT WAS IN THE OBESE RANGE BY BMI AT THE TIME OF INITIAL WHICH IS CONTRAINDICATED FOR TKA. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 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 ON (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. EXAMINATION OF THE LEFT KNEE DEMONST

  Patient problems: Pain

  MAUDE report 6360421 ↗
• InjuryFeb 27, 2017Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT A REVISION TKA PROCEDURE ON (B)(6) 2016 WHICH WAS PERFORMED BY A DIFFERENT SURGEON THAN PERFORMED THE ORIGINAL SURGERY. PER PATIENT'S ATTORNEY THE FACILITY HAS BEEN INSTRUCTED TO PRESERVE THE EXPLANTED DEVICES FOLLOWING IT'S REVIEW. PATIENT IS A MALE, (B)(6). THE PATIENT'S ORIGINAL LEFT TKA PROCEDURE WAS PERFORMED ON (B)(6) 2015. DURING THE ORIGINAL LEFT TKA PROCEDURE THE OP REPORT NOTED THAT THE CLOSURE WAS MORE EXTENSILE AND MORE DIFFICULT. THE ANESTHESIA TIME, OPERATIVE TIME AND TO TOURNIQUET TIME WERE PROLONGED. FOR THESE REASONS, THIS CASE WAS 30% MORE DIFFICULT. THE OP REPORT ALSO NOTED PATIENT HAD MORBID OBESITY WITH (B)(6). THE PATIENT WAS OVER 150 POUNDS GREATER THAN THEIR IDEAL WEIGHT. DURING THE ORIGINAL PROCEDURE THE FOLLOWING ARTHREX PARTS WERE IMPLANTED: TIBIAL TRAY AR-503-TTTH, LOT 1380708, FEMORAL IMPLANT AR-516-7L, LOT 1373719, BEARING IMPLANT AR-513-BH10, LOT 113601408 AND PATELLA IMPLANT AR-504-PSC9, LOT 113601437. THE TIBIAL TRAY WAS EXPLANTED ON (B)(6) 2016 BUT IT IS UNKNOWN WHAT ELSE MAY HAVE BEEN EXPLANTED DURING THE REVISION PROCEDURE. PATIENT ORIGINAL SURGEON MEDICAL RECORDS DATED (B)(6) 2015

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Swelling

  MAUDE report 6360418 ↗
• InjuryJan 18, 2017Loose or Intermittent Connection; Nonstandard Device; Device Dislodged or Dislocated

  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: Arthralgia; Failure of Implant

  MAUDE report 6259671 ↗
• InjurySep 21, 2016Failure To Adhere Or Bond

  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 DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTF LOT 108761230 ((B)(4)), BEARING IMPLANT AR-503-BF12 LOT 113601227 ((B)(4)) AND PATELLA IMPLANT AR-504-PSC9 LOT 113601324 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PARTS: TIBIAL TRAY AR-513-T5 LOT 10029414, BEARING IMPLANT AR-513-BF20 LOT 113601335, STEM EXTENSION IMPLANT AR-513-1450 LOT 10036355 AND PATELLA IMPLANT AR-504-PSC9 LOT 113601548. PATIENT WAS A FEMALE, (B)(6). PATIENT MEDICAL RECORDS DATE (B)(6) 2016 NOTED THE FOLLOWING: X-RAY FINDINGS OF THE LEFT KNEE SHOWED PROSTHESIS IN PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING, OR STRESS SHIELDING AND HARDWARE WAS NOTED IN ACCEPTABLE POSITION. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED THE FOLLOWING: APPROXIMATELY 1 YEAR POST OP (B)(6) 2014 LEFT TKA PATIENT BEGAN TO NOTICE PROGRESSING RETURN OF PAIN WITH NO REPORTED INJURY. PATIENT REPORTED SWELLING AS WELL TO THE POINT OF FEELING CLOSE TO PRE-OP (B)(6) 2014 STATUS. EXAMINATION OF TH

  Patient problems: Pain; Swelling

  MAUDE report 5966076 ↗
• InjurySep 9, 2016Loose or Intermittent Connection; 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)(CC95096-LINE 169384), FEMORAL IMPLANT AR-503-PSLF (LOT 108761212) (CC95096-LINE 169385), BEARING IMPLANT AR-503-BE12 (LOT 113601237) (CC95096-LINE 169386) AND PATELLA IMPLANT AR-504-PSC9 (LOT 113601237) (CC95096-LINE 169387). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE, DOB: (B)(6). 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: Pain; Swelling

  MAUDE report 5940724 ↗
• InjurySep 9, 2016Nonstandard Device; Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2015, 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-TTTE, LOT 1297084 ((B)(4)), FEMORAL IMPLANT AR-516-5R, LOT 108761350 ((B)(4)), BEARING IMPLANT AR-513-BE12, LOT 113601403 ((B)(4)) AND PATELLA IMPLANT AR-504-PSB8, LOT 113601439 ((B)(4)). TO COMPLETE THE PROCEDURE, THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE, DOB (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED THAT PATIENT HAS DEVELOPED PAIN AND SWELLING OF THE KNEE WITHOUT INJURY, DAILY MEDIAL PAIN THAT GETS WORSE WITH ACTIVITY. EXAMINATION OF THE RIGHT KNEE DEMONSTRATED SWELLING AND PALPATION OF THE KNEE DEMONSTRATED INFERIOR PATELLAR POLE TENDERNESS, MEDIAL TIBIAL PLATEAU TENDERNESS. MODERATE EFFUSION OF THE RIGHT KNEE WAS NOTED, ALONG WITH PAIN WITH FLEXION AND NO PAIN WITH EXTENSION. RECORDS NOTED X-RAYS OF RIGHT KNEE FOUND THE PROSTHESIS IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING, OR STRESS SHIELDING AND HARDWARE WAS NOTED TO BE IN ACCEPTABLE POSITION.

  Patient problems: Pain; Pleural Effusion; Swelling

  MAUDE report 5940610 ↗
• InjuryAug 5, 2016Break; Nonstandard Device

  IT WAS REPORTED THAT ON (B)(6) 2015, PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016 SURGEON PERFORMED A REVISION LEFT TKA DUE TO PATIENT PAIN. DURING THE REVISION PROCEDURE, THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTE (LOT 1297366 )((B)(6)), AND BEARING IMPLANT AR-513-BE08 (LOT 113601337A)((B)(6)). TO COMPLETE THE PROCEDURE, THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PARTS: TIBIAL TRAY AR-513-T4 (LOT 10038080), BEARING IMPLANT AR-513-BE13 (LOT 113601414) AND STEM EXTENSION IMPLANT AR-513-1450 (LOT 10036355). PATIENT WAS A FEMALE, AGE (B)(6). DURING THE REVISION PROCEDURE WHEN THE AR-613-1 UNIVERSAL HANDLE LOT 1391544 ((B)(6)) WAS BEING USED FOR THE REMOVAL OF THE TIBIAL PUNCH HEAD. THE PUNCH HEAD WAS ABLE TO BE REMOVED BUT THE HANDLE BROKE IN THE PROCESS WHICH DID NOT RESULT IN PATIENT HARM. HANDLE IS BEING RETURNED FOR EVALUATION. PATIENT MEDICAL RECORDS OF (B)(6) 2016 NOTED THAT PATIENT WAS REPORTING CONTINUED KNEE PAIN AND SWELLING. PATIENT WAS INJECTED AND ASPIRATED AT THAT TIME. ON (B)(6) 2016 RECORDS NOTED THAT INJECTION/ASPIRATION HELPED WITH SYMPTOMS FOR ONLY A FEW DAYS. EXAMINATION OF THE LEFT KNEE DEMONSTRATED SWELLING. PALPATION OF THE LEFT KNEE DEMONSTRAT

  Patient problems: Joint Swelling; Pain

  MAUDE report 5851598 ↗
• InjuryJul 26, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2015, A PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2016 THE SURGEON PERFORMED A REVISION LEFT TKA PROCEDURE DUE TO PATIENT PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTE (LOT 1379201), FEMORAL IMPLANT AR-516-5L (LOT 1373716), BEARING IMPLANT AR-513-BE12 (LOT 113601433) AND PATELLA IMPLANT AR- 504-PSB8 (LOT 113601439). PATIENT, FEMALE, (B)(6). DURING THE REVISION PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: TIBIAL TRAY AR-513-T5 (LOT 10034400), FEMORAL IMPLANT AR-516-5L (LOT 1482387), BEARING IMPLANT AR-513-BF18 (LOT 113601335) AND PATELLA IMPLANT AR-504-PSC9 (LOT 113601511). PATIENT MEDICAL RECORDS OF (B)(6) 2016 NOTED PATIENT WAS EXPERIENCING RECURRENT SWELLING IN LEFT KNEE, ANY JARRING MOTION OF KNEE RECREATED PAIN IN KNEE AND PATIENT IS ABLE TO DO STAIRS ONE AT A TIME. EXAMINATION OF THE LEFT KNEE DEMONSTRATED SWELLING AND PALPATION OF THE LEFT KNEE DEMONSTRATED MEDIAL TIBIAL PLATEAU TENDERNESS AND LATERAL TIBIAL PLATEAU TENDERNESS. MILD EFFUSION OF THE LEFT KNEE WAS NOTED ALONG WITH PAIN WITH FLEXION. IT WAS NOTED PATIENT MAY HAVE MICROMOTION TIBIAL COMPONENT. PATIENT MEDICAL RECORDS OF (B)

  Patient problems: Pain; Swelling

  MAUDE report 5822739 ↗