Arthrex® AR-503-TTTDRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867106710), received between Aug 29, 2016 and Mar 2, 2021 — 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 18, 2026.

Recalls naming this device

1. Dec 17, 2015Class IITerminated

   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.

• InjuryMar 2, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE SALES REP THAT A REVISION TOTAL KNEE PROCEDURE TOOK PLACE ON (B)(6) 2021. THE REASON FOR THE REVISION WAS DUE TO TIBIAL LOOSENING. THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED DURING THIS SURGERY AR-5030PSLF, LOT: 108761213; AR-503-TTTD, LOT: 108761149; AR-503-BD08, LOT: 113601218. ONCE THE DEVICES WERE EXPLANTED, THE SURGEON PERFORMED A METACTA HINGED TOTAL KNEE PROCEDURE. THE SALES REP REPORTED THAT THEY CANNOT CONFIRM THE PART AND LOT NUMBERS OF THE ARTHREX PRODUCT IMPLANTED DURING THE REVISION SURGERY. THE SALES REP STATED THAT THE PROCEDURE WAS SUCCESSFUL WITHOUT ANY PRODUCT MALFUNCTIONS. THE PRIMARY PROCEDURE TOOK PLACE ON (B)(6) 2013. THE SALES REP REPORTED THAT IT CANNOT BE CONFIRMED THE PLACE WHERE THE PRIMARY PROCEDURE WAS PERFORMED. THE PRIMARY PROCEDURE WAS PERFORMED BY A DIFFERENT SURGEON. THE EXPLANTED ARTHREX DEVICES WILL BE RETURNED FOR EVALUATION.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 11398479 ↗
• InjuryOct 1, 2019Loose or Intermittent Connection; Nonstandard Device

  IT WAS REPORTED THAT THE PATIENT HAD A BI-LATERAL TKA PROCEDURE (B)(6) 2014 DURING WHICH TIME THE PATELLA WAS NOT RESURFACED. ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION LEFT TKA BY THE SAME SURGEON. THE REVISION WAS DONE BECAUSE THE PATIENT X-RAYS WERE REPORTED TO SHOW TIBIAL SUBSIDENCE CAUSING CHRONIC PAIN. THE REVISION WAS COMPLETED BY USING ANOTHER MANUFACTURER'S PRODUCT. THE FOLLOWING ARE THE ARTHREX PRODUCTS WHICH WERE ORIGINALLY IMPLANTED DURING THE 2014 PROCEDURE. EACH OF THESE PRODUCTS WERE EXPLANTED ON (B)(6) 2019: AR-503-TTTD TIBIAL TRAY IMPLANT (LOT 1191337), AR-503-PSLE FEMORAL IMPLANT (LOT 108761324), AR-503-BD12 BEARING IMPLANT (LOT 113601234).

  Patient problems: Pain

  MAUDE report 9141203 ↗
• 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. (CASE (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 8970700 ↗
• InjuryJun 19, 2019Loose or Intermittent Connection; Nonstandard Device

  IT WAS REPORTED VIA PATIENT LEGAL REPRESENTATIVE THAT A PATIENT HAD UNDERGONE A LEFT TOTAL KNEE REPLACEMENT PROCEDURE ON (B)(6) 2014. DURING THE 2014 PROCEDURE THE FOLLOWING DEVICES WERE IMPLANTED: AR-503-TTTD (LOT 780838) TIBIAL TRAY IMPLANT; AR-516-5L (LOT 1279940) FEMORAL IMPLANT; AR-513-BD12 (LOT 113601329) TIBIAL BEARING IMPLANT; AR-504-PSC9 (LOT 113601411) PATELLA IMPLANT. ON (B)(6) 2016 THE PATIENT UNDERWENT A REVISION LEFT TKA PROCEDURE DUE TO LOOSENING OF THE LEFT TOTAL KNEE. DURING THE REVISION PROCEDURE ALL ARTHREX IMPLANTS FROM THE (B)(6) 2014 PROCEDURE WERE EXPLANTED. THE SURGERY WAS COMPLETED BY IMPLANTING ANOTHER MANUFACTURER'S PRODUCT. ADDITIONAL INFORMATION RECEIVED ON 5/29/2019: IT WAS REPORTED IN THE PATIENT'S MEDICAL RECORDS DATED (B)(6) 2014 THAT THE PATIENT FELL DIRECTLY ON HER KNEE TWO WEEKS PRIOR TO THE FOLLOW UP APPOINTMENT. MEDICAL RECORDS DATED (B)(6) 2015 NOTE THAT THE PATIENT WAS DOING FAIR AND FUNCTIONALLY THE LEFT KNEE IS DOING WELL BUT SHE HAS HAD MULTIPLE FALLS FOR UNKNOWN CAUSES. SURGEON DISCUSSED THAT HER FALLS PLAY A SIGNIFICANT ROLE IN HER RECOVERY. ADDITIONAL MEDICAL RECORDS DATED (B)(6) 2015 NOTE THAT THE PATIENT'S BONE SCAN WAS POSITIVE FOR L

  Patient problems: Fall

  MAUDE report 8711104 ↗
• InjuryNov 20, 2018Loose or Intermittent Connection

  IT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATIVE THAT THE PATIENT HAD UNDERGONE A LEFT KNEE MENISECTOMY AND "CHRONDROPLASTY" ON (B)(6) 2015. THEREAFTER, ON (B)(6) 2015 THE PATIENT HAD A HEMI-ARTHROPLASTY ON HER LEFT KNEE. THE RECORDS PROVIDED LIST THAT THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE (B)(6) 2015 PROCEDURE: AR-501-TTLB IBALANCE UNI-TIBIAL TRAY (LOT 108761228), AR-501-UFLC IBALANCE UNI-FEMORAL IMPLANT (LOT 1470559) AND AR-501-TBB0 IBALANCE UKA TIBIAL BEARING (LOT 77941142). ON (B)(6) 2015 THE PATIENT UNDERWENT ANOTHER SURGERY CONVERTING THE UNI-KNEE TO A TOTAL KNEE REPLACEMENT. ACCORDING TO THE MEDICAL RECORDS THE PRE-OP DIAGNOSIS, AND X-RAY FINDINGS PRIOR TO THE (B)(6) 2015 PROCEDURE NOTE A LOOSE FEMORAL COMPONENT. HOWEVER, THE OPERATIVE REPORT NOTES THAT THE TIBIAL BASEPLATE WAS LOOSE, NOT THE FEMORAL COMPONENT. DURING THE PROCEDURE THE HEMI-ARTHROPLASTY IMPLANTS WERE REMOVED AND THE FOLLOWING LEFT TKA IBALANCE SYSTEM COMPONENTS WERE IMPLANTED: AR-503-TTTD TIBIAL BASEPLATE (LOT 1297044), AR-517-4L FEMORAL IMPLANT (LOT 1438430), AR-503-A313 TIBIAL BEARING IMPLANT (13MM) (LOT 113601414) AND AR-504-PSA8 PATELLA IMPLANT (LOT 113601322). ANOTHER MANUFACTURE

  Patient problems: Failure of Implant

  MAUDE report 8089145 ↗
• InjuryApr 10, 2017Failure To Adhere Or Bond; Nonstandard Device

  IT WAS REPORTED THAT ON (B)(6) 2015 PATIENT UNDERWENT BILATERAL TKA PROCEDURE. PATIENT HAD A REVISION LEFT TKA ON (B)(6) 2017 DUE TO TIBIAL LOOSENING AND PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTE (LOT 1297366), AND BEARING IMPLANT AR-513-BE09 (LOT 113601338A). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PRODUCTS: TIBIAL TRAY, AR-513-T4 (LOT 10060962) AND BEARING IMPLANT, AR-513-BE16 (LOT 113601340). THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM PATIENT MEDICAL RECORDS: RECORDS DATED (B)(6) 2016: PATIENT BIKES, KAYAKS AND DOES WATER AEROBICS AND THINKS SHE MAY HAVE OVERDONE IT. X-RAY FINDINGS LEFT KNEE: PROSTHESIS IN PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING OR STRESS SHIELDING. RECORDS DATED (B)(6) 2017: PATIENT HAS BEEN HAVING INCREASED LEFT KNEE PAIN. ASPIRATION FLUID TWO MONTHS PRIOR WAS NEGATIVE FOR INFECTION. PATIENT REPORTED IT FELT LIKE A TIGHT BAND ACROSS HER KNEE WITH THROBBING AND BURNING PAIN IN THE ANTERIOR TIBIA. EXAMINATION OF THE LEFT KNEE DEMONSTRATED NO SWELLING OR ECCHYMOSIS. PALPATION OF THE LEFT KNEE DEMONSTRATED MEDICAL JOINT LINE AND MEDIAL TIBIAL PLATEAU TEND

  Patient problems: Pain

  MAUDE report 6476676 ↗
• InjuryApr 4, 2017Nonstandard Device; Patient-Device Incompatibility

  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 (B)(6) 2017 REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTD (LOT 1297049) ((B)(4)), FEMORAL IMPLANT AR-516-4R (LOT 1368092) ((B)(4)), PATELLA IMPLANT AR-504-PSC9 (LOT 113601437) ((B)(4)) AND BEARING IMPLANT AR-513-BD14 (LOT 113601329) ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT IS A FEMALE, (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. EXAMINATION OF RIGHT KNEE DEM

  Patient problems: Failure of Implant; Pain

  MAUDE report 6456514 ↗
• InjuryFeb 10, 2017Failure To Adhere Or Bond; Unstable

  IT WAS REPORTED THAT ON (B)(6) 2015 A PATIENT UNDERWENT A RIGHT TKA PROCEDURE. ON (B)(6) 2017 PATIENT HAD A RIGHT TKA REVISION DUE TO TIBIAL LOOSENING. DURING THE REVISION SURGERY THE FOLLOWING ARTHREX PRODUCTS WERE EXPLANTED: TIBIAL TRAY, AR-503-TTTF, LOT 108761211 ((B)(4)) AND THE BEARING IMPLANT AR-513-BF10, LOT 113601414 ((B)(4)). TO COMPLETE THE PROCEDURE AN ARTHREX TIBIAL TRAY SIZE 6 AND AN ARTHREX BEARING IMPLANT 16 MM WERE IMPLANTED. PATIENT IS A FEMALE, DOB: (B)(6). PATIENT HAD A HISTORY OF MORBID OBESITY WITH A GASTRIC BYPASS SURGERY. PATIENT WAS IN THE OBESE RANGE BY BMI ((B)(6)) AT THE TIME OF REVISION WHICH IS CONTRAINDICATED FOR TKA. SURGEON REPORTED THAT PATIENT FELL POST OPERATIVELY. BONE SCAN RESULTS (B)(6) 2016: INITIAL PERFUSION IMAGES WERE UNREMARKABLE. THE BLOOD POOL AND DELAYED IMAGES DEMONSTRATED INCREASE ACTIVITY IN THE REGION OF THE RIGHT PROXIMAL TIBIA MEDIALLY GREATER THAN LATERALLY. IT WAS NOTED THAT THIS IS LIKELY RELATED TO POSTSURGICAL CHANGE. RESULTS MENTIONED THAT INFECTION/LOOSENING IS LESS LIKELY BUT CANNOT BE EXCLUDED. DIAGNOSIS INDICATED PROBABLE POST-SURGICAL CHANGES OF THE RIGHT KNEE. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED: PATIENT RE

  Patient problems: Fall; Pain; Swelling

  MAUDE report 6321859 ↗
• InjuryFeb 10, 2017Failure To Adhere Or Bond; Nonstandard Device

  IT WAS REPORTED BY A PATIENT THROUGH THE ARTHREX WEBSITE THAT THE PATIENT HAD UNDERGONE A LEFT TKA PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE THE FOLLOWING ARTHREX PARTS WERE IMPLANTED: TIBIAL TRAY-SIZE 4, AR-503-TTTE, LOT 1297084 ((B)(4)), FEMORAL IMPLANT, AR-516-4L, LOT 1361640, BEARING IMPLANT, AR-513-BE16, LOT 113601331A ((B)(4)) AND PATELLA IMPLANT, AR-504-PSC9, LOT 113601437. PATIENT UNDERWENT A REVISION SURGERY DUE TO TIBIAL LOOSENING ON (B)(6) 2016. PER (B)(6) 2016 REVISION OPERATIVE REPORT: THE POLY BEARING IMPLANT WAS REMOVED. THE PATIENT'S FEMORAL COMPONENT WAS EVALUATED AND FOUND TO BE SECURE. THE INTERFACE BETWEEN THE TIBIAL COMPONENT WAS DISRUPTED WITH A OSTEOTOME AND THE TIBIAL COMPONENT WAS REMOVED WITHOUT DIFFICULTY. OPERATIVE REPORT NOTED THAT THE COMPONENT WAS LOOSE. TO COMPLETE THE PROCEDURE A TIBIAL TRAY - SIZE 3 AND AN 18 MM POLY BEARING IMPLANT WERE IMPLANTED. CULTURES WERE TAKEN DURING THE REVISION PROCEDURE: GRAM STAIN REVEALED: WHITE BLOOD CELLS - FEW, EPITHELIAL CELLS - NONE OBSERVED AND BACTERIA - NON OBSERVED. WOUND CULTURE REVEALED: NO GROWTH. ANAEROBIC CULTURE REVEALED: NO ANAEROBES WERE RECOVERED.

  Patient problems: No Code Available

  MAUDE report 6321846 ↗
• InjuryJan 24, 2017Loose or Intermittent Connection; Nonstandard Device

  IT WAS REPORTED THAT ON (B)(6) 2015 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-TTTH LOT 1206181 ((B)(6) (B)(4)), FEMORAL IMPLANT AR-516-7R LOT 108761338 ((B)(4) (B)(6)) AND BEARING IMPLANT AR-513-BH14 LOT 113601336 ((B)(6) (B)(4)). THE ORIGINAL PATELLA IMPLANT WAS LEFT IN THE PATIENT. TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE, AGE (B)(6), DOB (B)(6) 1970. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED: PATIENT HAS COMPLAINED OF CHRONIC KNEE PAIN EVER SINCE THE ORIGINAL SURGERY. REVISION TKA HAD BEEN SCHEDULED EARLIER BUT WAS POSTPONED DUE TO PERSONAL REASONS. RECORDS NOTED THAT A PREVIOUS BONE SCAN DEMONSTRATED POSSIBLE LOOSENING OF THE TIBIAL COMPONENT. EXAMINATION OF THE RIGHT KNEE DEMONSTRATED WARMTH AND SWELLING BUT NO ERYTHEMA. PALPATION OF THE RIGHT KNEE DEMONSTRATED INFERIOR PATELLA POLE TENDERNESS, MEDIAL AND LATERAL JOINT LINE TENDERNESS AND MEDIAL TIBIAL PLATEAU TENDERNESS. MILD EFFUSION OF THE RIGHT KNEE WAS NOTED. RECORDS ALSO NOTED THAT THE PATIENT HAS PAIN TH

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 6272371 ↗
• InjuryJan 13, 2017Failure To Adhere Or Bond; Nonstandard Device

  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-TTTE LOT 913623 ((B)(4)), FEMORAL IMPLANT AR-503-PSLE LOT 108761324 ((B)(4)), BEARING IMPLANT AR-503-BE15 LOT 654425 ((B)(4)) AND PATELLA IMPLANT AR-504-PSC9 LOT 113601237 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE, (B)(6). MEDICAL RECORDS DATED (B)(6) 2016 NOTED: EXAMINATION OF THE LEFT KNEE WITH PALPATION DEMONSTRATED INFERIOR POLE PATELLA AND MEDIAL TIBIAL PLATEAU TENDERNESS. MILD EFFUSION OF THE LEFT KNEE WAS NOTED. RANGE OF MOTION EXAMINATION OF THE LEFT KNEE DEMONSTRATED CREPITUS WITH MOTION. RECORDS NOTED THAT THE X-RAYS SHOWED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING. BONE SCAN WAS PERFORMED ON BOTH KNEES ON (B)(6) 2016: RESULTS STATED THERE WAS INCREASED UPTAKE INVOLVING BOTH KNEE REPLACEMENTS, THE LEFT SIDE MORE INCREASED THAN THE RIGHT. IT WAS ALSO NOTED THAT THIS MAY SUGGEST LOOSENING WHICH IS WORSE ON THE LEFT THAN THE RIGHT.

  Patient problems: No Code Available

  MAUDE report 6250940 ↗
• InjuryOct 10, 2016Loose or Intermittent Connection; Nonstandard Device

  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 DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTD LOT 1297049 ((B)(4)) AND BEARING IMPLANT AR-513-BD08 LOT 113601337 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PRODUCTS: TIBIAL TRAY AR-513-T4 LOT 10038080, BEARING IMPLANT AR-513-BE13 LOT 113601339A AND STEM EXTENSION IMPLANT AR-513-1450 LOT 1002348. PATIENT WAS A FEMALE, (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT HAS A FALL IN (B)(6) 2016. AFTER FALL PATIENT WAS TREATED WITH KNEE ASPIRATION AND INJECTION. PATIENT WAS TREATED FOR CONTUSION. IT WAS FURTHER NOTED THAT PATIENT CONTINUES TO HAVE RECURRENT SWELLING IN HER KNEE AND POSTERIOR MEDIAL PAIN WITH SNAPPING SENSATION. MEDICAL RECORDS NOTED PATIENT WAS FINE UNTIL THE FALL. EXAMINATION OF THE LEFT KNEE DEMONSTRATED SWELLING BUT NO ERYTHEMA OR ECCHYMOSIS. PALPATION OF LEFT KNEE DEMONSTRATED MEDIAL JOINT LINE TENDERNESS BUT NO LATERAL JOINT LINE TENDERNESS. MILD EFFUSION OF THE LEFT KNEE WAS NOTED.

  Patient problems: Contusion; Fall; Pain

  MAUDE report 6015411 ↗
• InjuryOct 10, 2016Failure To Adhere Or Bond; Nonstandard Device; Unstable

  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 DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE, THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTE LOT 1336453 ((B)(4)), FEMORAL IMPLANT AR-516-4L LOT 108761402((B)(4)), BEARING IMPLANT AR-513-BD13 LOT 113601339 ((B)(4)) AND PATELLA IMPLANT AR-504-PSB8 LOT 113601236 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE, (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED X-RAY FINDINGS OF LEFT KNEE AS FOLLOWS: MILD TILT OF PATELLA, PROSTHESIS IN PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING OR STRESS SHIELDING. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED THAT A BONE SCAN SHOWED UPTAKE. REPORT STATES PATIENT CONTINUED TO HAVE PAIN WALKING, PAIN IS WITH EVERY STEP, AND ALSO NOTED PATIENT HAS SHARP PAIN MEDIAL ANTERIOR KNEE WITH ROTATION OF KNEE. PATIENT ALSO REPORTED SOME INSTABILITY IN KNEE AND DIFFICULTY STANDING UP AFTER PROLONGED SITTING. EXAMINATION OF THE LEFT KNEE DEMONSTRATED INFERIOR POLE PATELLA TENDERNESS AND MEDIAL TIBIAL PLATEAU TENDERNESS BUT NO MEDIAL

  Patient problems: Pain

  MAUDE report 6013889 ↗
• InjuryAug 29, 2016Appropriate Device Problem Term/Code Not Available

  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, (B)(6). 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 TIBIAL PLA

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

  MAUDE report 5911796 ↗