Arthrex® AR-503-TTTCRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867106703), received between Jul 26, 2016 and Dec 19, 2016 — classified as 15 injuries.

The most frequently reported specific device problem is “Nonstandard Device” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2016Loose or Intermittent Connection

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TKA ON (B)(6) 2014 DURING WHICH THE PATELLA WAS NOT RESURFACED. ON (B)(6) 2016 PATIENT HAD A LEFT TKA REVISION SURGERY ((B)(4)). DURING THE (B)(6) 2016 REVISION THE ORIGINAL TKA AND BEARING IMPLANT WERE EXPLANTED AND THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED: TIBIAL TRAY, STEM EXTENSION, BEARING IMPLANT AND PATELLA IMPLANT. ON (B)(6) 2016 THE PATIENT UNDERWENT A SECOND LEFT TKA REVISION SURGERY DUE TO A REPORTED LOOSE TIBIA AND FEMUR. THE FOLLOWING PARTS WERE EXPLANTED DURING THE (B)(6) 2016 PROCEDURE: TIBIAL TRAY AR- 513-T8, LOT 10019689 ((B)(4)), FEMORAL IMPLANT AR-503-PSLJ, LOT 108761211 ((B)(4)), STEM EXTENSION AR-513-1250, LOT 10018106 ((B)(4)), TIBIAL BEARING AR-513-BJ18, LOT 113601327 ((B)(4)) AND PATELLA IMPLANT AR-504-PSC9, LOT 113601511 ((B)(4)). TO COMPLETE THE REVISION THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCTS. PATIENT IS A MALE, (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED: X-RAYS SHOWED NO ACUTE FRACTURE, NO ACUTE DISLOCATION, NO LOOSE BODIES NOTED, PROSTHESIS IN GOOD PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING OR STRESS SHIELDING AND HARDWARE NOTED IN ACCEPTABLE POSITION. PATIENT

  Patient problems: Discomfort; Joint Swelling; No Code Available; Pain

  MAUDE report 6184908 ↗
• InjuryDec 19, 2016Unintended Movement

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT TKA ON (B)(6) 2014 DURING WHICH THE PATELLA WAS NOT RESURFACED. ON (B)(6) 2016 PATIENT HAD A LEFT TKA REVISION SURGERY ((B)(4)). DURING THE 5/11/16 REVISION THE ORIGINAL TKA AND BEARING IMPLANT WERE EXPLANTED AND THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED: TIBIAL TRAY, STEM EXTENSION, BEARING IMPLANT AND PATELLA IMPLANT. ON (B)(6) 2016 THE PATIENT UNDERWENT A SECOND LEFT TKA REVISION SURGERY DUE TO A REPORTED LOOSE TIBIA AND FEMUR. THE FOLLOWING PARTS WERE EXPLANTED DURING THE (B)(6) 2016 PROCEDURE: TIBIAL TRAY AR- 513-T8, LOT 10019689 ((B)(4) (B)(6)), FEMORAL IMPLANT AR-503-PSLJ, LOT 108761211 ((B)(4) (B)(6)), STEM EXTENSION AR-513-1250, LOT 10018106 ((B)(4) (B)(6)), TIBIAL BEARING AR-513-BJ18, LOT 113601327 ((B)(4) (B)(6)) AND PATELLA IMPLANT AR-504-PSC9, LOT 113601511 ((B)(4) (B)(6)). TO COMPLETE THE REVISION THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCTS. PATIENT IS A MALE, AGE (B)(6), DOB (B)(6) 1957. PATIENT MEDICAL RECORDS DATED 5/27/16 NOTED: X-RAYS SHOWED NO ACUTE FRACTURE, NO ACUTE DISLOCATION, NO LOOSE BODIES NOTED, PROSTHESIS IN GOOD PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING OR STRESS SHIELDING AND

  Patient problems: Joint Disorder; Joint Swelling

  MAUDE report 6184886 ↗
• InjuryDec 19, 2016Failure To Adhere Or Bond

  IT WAS REPORTED THAT ON (B)(6) 2013 A PATIENT UNDERWENT A RIGHT TKA PROCEDURE. ON (B)(6) 2016 SURGEON PERFORMED A REVISION RIGHT TKA DUE TO TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTC LOT 108761313, ((B)(4) (B)(6)) AND BEARING IMPLANT AR-503-BC12 LOT 113601233 ((B)(4) (B)(6)). TO COMPLETE THE PROCEDURE THE SURGEON USED TIBIAL TRAY AR-513-T3, LOT 1002043 AND BEARING IMPLANT, AR-513-BD20 LOT 113601351. PATIENT WAS A FEMALE, AGE (B)(6), DOB (B)(6) 1944. PATIENT MEDICAL RECORDS DATED (B)(6) 2015 NOTED: X-RAYS OF THE RIGHT KNEE SHOWED HYPERTROPHIC BONE FORMATION, NATIVE PATELLA, BUT PROSTHESIS IN PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING, OR STRESS SHIELDING. PATIENT MEDICAL RECORDS DATE (B)(6) 2016 NOTED: EXAMINATION OF RIGHT KNEE SHOWED NO VISIBLE ABNORMALITIES. PALPATION OF THE RIGHT KNEE DEMONSTRATED MEDIAL JOINT LINE TENDERNESS AND MEDIAL TIBIAL PLATEAU TENDERNESS. IT WAS NOTED THERE WAS NO EFFUSION OF THE RIGHT KNEE. RECORDS NOTED THE PATIENT BONE SCAN FINDINGS AS FOLLOWS: IMPRESSION-MODERATE UPTAKE WITHIN THE B/L KNEES PROSTHESIS. RIGHT KNEE GREATER THAN LEFT.

  Patient problems: No Code Available

  MAUDE report 6184842 ↗
• 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)(4)). 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)(4) (B)(6)), FEMORAL IMPLANT AR-503-PSLF, LOT 108761213 ((B)(4) (B)(6)), BEARING IMPLANT AR-513-BE14, LOT 113601330A ((B)(4) (B)(6)) AND PATELLA IMPLANT AR-504-PSD0, LOT 113601415 ((B)(4) (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

  Patient problems: Pain; Swelling

  MAUDE report 6142637 ↗
• InjuryNov 22, 2016Insufficient Device Problem Information

  IT WAS REPORTED THAT ON 6/15/2015 A PATIENT UNDERWENT A RIGHT TKA PROCEDURE. ON 10/31/2016 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 1307267 (CC99503 LINE 174688), FEMORAL IMPLANT AR-516-4R, LOT 108761424 (CC99503 LINE 174689), BEARING IMPLANT AR-513-BD14, LOT 113601340 (CC99503 LINE 174690) AND PATELLA IMPLANT AR-504-PSB8, LOT 113601323 (CC99503 LINE 174813). 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 EXAMINATION OF THE RIGHT KNEE FOUND MILD EFFUSION OF THE RIGHT KNEE. RIGHT KNEE DEMONSTRATED NO PAIN ASSOCIATED WITH MOTION IN ANY DIRECTION. MILD MID-FLEXION LAXITY WAS NOTED. PATIENT HAS PAIN IN THE KNEE THAT IS INCREASED WITH ACTIVITY AND WEIGHT BEARING, AS WELL AS INTERFERENCE WITH ACTIVITIES OF DAILY LIVING. PAIN THROUGH A LIMITED PASSIVE RANGE OF MOTION WITH CREPITUS AND SWELLING. X-RAY RECORDS ALSO NOTED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING.

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

  MAUDE report 6120589 ↗
• InjuryNov 22, 2016Adverse Event Without Identified Device or Use Problem

  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 PATIENT PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTD, LOT 1307267 (CC99503 LINE 174688), FEMORAL IMPLANT AR-516-4R, LOT 108761424 (CC99503 LINE 174689), BEARING IMPLANT AR-513-BD14, LOT 113601340 (CC99503 LINE 174690) AND PATELLA IMPLANT AR-504-PSB8, LOT 113601323 (CC99503 LINE 174813). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE, AGE (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED EXAMINATION OF THE RIGHT KNEE FOUND MILD EFFUSION OF THE RIGHT KNEE. RIGHT KNEE DEMONSTRATED NO PAIN ASSOCIATED WITH MOTION IN ANY DIRECTION. MILD MID-FLEXION LAXITY WAS NOTED. PATIENT HAS PAIN IN THE KNEE THAT IS INCREASED WITH ACTIVITY AND WEIGHT BEARING, AS WELL AS INTERFERENCE WITH ACTIVITIES OF DAILY LIVING. PAIN THROUGH A LIMITED PASSIVE RANGE OF MOTION WITH CREPITUS AND SWELLING. X-RAY RECORDS ALSO NOTED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING.

  Patient problems: Loss of Range of Motion; Pain; Swelling

  MAUDE report 6120578 ↗
• InjuryNov 22, 2016Nonstandard Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015 A PATIENT UNDERWENT A RIGHT TKA PROCEDURE. ON 10/31/2016 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 1307267 (CC99503 LINE 174688), FEMORAL IMPLANT AR-516-4R, LOT 108761424 (CC99503 LINE 174689), BEARING IMPLANT AR-513-BD14, LOT 113601340 (CC99503 LINE 174690) AND PATELLA IMPLANT AR-504-PSB8, LOT 113601323 (CC99503 LINE 174813). 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 EXAMINATION OF THE RIGHT KNEE FOUND MILD EFFUSION OF THE RIGHT KNEE. RIGHT KNEE DEMONSTRATED NO PAIN ASSOCIATED WITH MOTION IN ANY DIRECTION. MILD MID-FLEXION LAXITY WAS NOTED. PATIENT HAS PAIN IN THE KNEE THAT IS INCREASED WITH ACTIVITY AND WEIGHT BEARING, AS WELL AS INTERFERENCE WITH ACTIVITIES OF DAILY LIVING. PAIN THROUGH A LIMITED PASSIVE RANGE OF MOTION WITH CREPITUS AND SWELLING. X-RAY RECORDS ALSO NOTED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING.

  Patient problems: Pain; Swelling

  MAUDE report 6120565 ↗
• InjuryNov 22, 2016Insufficient Device Problem Information

  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 PATIENT PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTD, LOT 1307267 ((B)(4)), FEMORAL IMPLANT AR-516-4R, LOT 108761424 ((B)(4)), BEARING IMPLANT AR-513-BD14, LOT 113601340 ((B)(4)) AND PATELLA IMPLANT AR-504-PSB8, LOT 113601323 ((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 EXAMINATION OF THE RIGHT KNEE FOUND MILD EFFUSION OF THE RIGHT KNEE. RIGHT KNEE DEMONSTRATED NO PAIN ASSOCIATED WITH MOTION IN ANY DIRECTION. MILD MID-FLEXION LAXITY WAS NOTED. PATIENT HAS PAIN IN THE KNEE THAT IS INCREASED WITH ACTIVITY AND WEIGHT BEARING, AS WELL AS INTERFERENCE WITH ACTIVITIES OF DAILY LIVING. PAIN THROUGH A LIMITED PASSIVE RANGE OF MOTION WITH CREPITUS AND SWELLING. X-RAY RECORDS ALSO NOTED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING.

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

  MAUDE report 6120561 ↗
• InjuryNov 21, 2016Nonstandard Device

  IT WAS REPORTED THAT ON (B)(6) 2014 A PATIENT UNDERWENT A BI-LATERAL TKA PROCEDURE (DURING WHICH TIME THE PATELLA WAS NOT RESURFACED). 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-TTTJ, LOT 957056 ((B)(4)), FEMORAL IMPLANT AR-503-PSLJ, LOT 108761215 ((B)(4)) AND BEARING IMPLANT AR-503-BJ15, LOT 113601231 ((B)(4)). TO COMPLETE THE PROCEDURE, THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT HAS PERSISTENT ANTERIOR LEFT KNEE PAIN WHICH WAS AGGRAVATED THREE WEEKS PRIOR WHILE STEPPING OFF A FORKLIFT AT WORK. RECORDS NOTED PATIENT HAD BEEN DOING VERY WELL UNTIL THE RECENT WORK INJURY. EXAMINATION OF THE LEFT KNEE DEMONSTRATED WARMTH AND SWELLING BUT NO ERYTHEMA. PALPATION OF THE LEFT KNEE DEMONSTRATED INFERIOR POLE PATELLA TENDERNESS AND MEDIAL JOINT LINE TENDERNESS, BUT NO LATERAL JOINT LINE TENDERNESS. TRACE EFFUSION OF THE LEFT KNEE WAS NOTED. ROM EXAMINATION OF THE LEFT KNEE DEMONSTRATED PATELLA-FEMORAL CREPITUS WITH MOTION. PATIENT HAD A POSITIVE PATELLA GRIND TEST. RECORDS NOTED X-RAY SHOWED

  Patient problems: Alteration In Body Temperature; Pain; Swelling

  MAUDE report 6117805 ↗
• InjuryNov 21, 2016Insufficient Device Problem Information

  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 PROCEDURE DUE TO PATIENT PAIN. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTH , LOT 108761152 (CC98983 LINE 174080), FEMORAL IMPLANT AR-516-7R, LOT 108761338 (CC98983 LINE 174081), BEARING IMPLANT AR-513-BH11, LOT 113601408 (CC98983 LINE 174082) AND PATELLA IMPLANT AR-504-PSD0, LOT 113601430 (CC98983 LINE 174083). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, DOB (B)(6). PATIENT MEDICAL RECORDS DATE (B)(6) 2016 NOTED: EXAMINATION OF THE RIGHT KNEE DEMONSTRATED NO ERYTHEMA AND NO ECCHYMOSIS. PALPATION OF THE RIGHT KNEE DEMONSTRATED INFERIOR PATELLA POLE TENDERNESS, MEDIAL JOINT LINE TENDERNESS, LATERAL JOINT LINE TENDERNESS AND MEDIAL TIBIAL PLATEAU TENDERNESS. TRACE EFFUSION OF THE RIGHT KNEE WAS NOTED. RECORDS NOTED PATIENT HAD PAIN THROUGH A LIMITED PASSIVE RANGE OF MOTION WITH CREPITUS AND SWELLING. X-RAYS WERE NOTED TO SHOW PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING.

  Patient problems: Pain

  MAUDE report 6117785 ↗
• InjuryNov 16, 2016Nonstandard Device; Device Operates Differently Than Expected

  IT WAS REPORTED BY A PATIENT'S WIFE THAT HER HUSBAND, THE PATIENT, WAS SCHEDULED FOR A TKA REVISION SURGERY. ORIGINAL LEFT TKA PROCEDURE TOOK PLACE ON (B)(6) 2015. THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE (B)(6) 2015 PROCEDURE: TIBIAL TRAY, AR-503-TTTE LOT 1336468 ((B)(4)), FEMORAL IMPLANT, AR-516-5L LOT 1373716 ((B)(4)), BEARING IMPLANT, AR-513-BE12 LOT 113601403 ((B)(4)) AND PATELLA IMPLANT AR-504-PSB8 LOT 113601236 ((B)(4)). ADDITIONAL INFORMATION OBTAINED (B)(6) 2016: REVISION SURGERY TOOK PLACE (B)(6) 2016. REVISION WAS REPORTED DUE TO LOOSE TIBIA. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE IMPLANTS LISTED PREVIOUSLY AND COMPLETED THE PROCEDURE USING ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, DOB (B)(6) 1968, AGE (B)(6). PATIENT MEDICAL RECORDS DATE 8/16/16 NOTED: PATIENT IS A MAINTENANCE WORKER, HEAVY LABOR JOB, A LOT OF STAIRS, KNEELING, LIFTING. HE DOES WALK UP TO 8 MILES A DAY DUE TO JOB-MAINTENANCE. EXAMINATION OF THE LEFT KNEE DEMONSTRATED SWELLING, BUT NO WARMTH. PALPATION OF THE LEFT KNEE DEMONSTRATED MEDIAL JOINT LINE TENDERNESS AND MEDIAL TIBIAL PLATEAU TENDERNESS, BUT NO LATERAL JOINT LINE TENDERNESS. THERE WAS NO PAIN WITH EXTE

  Patient problems: Pain; Swelling

  MAUDE report 6105966 ↗
• InjuryNov 4, 2016Failure To Adhere Or Bond

  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 TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTD LOT 108761205 ((B)(6)), FEMORAL IMPLANT AR-503-PSRE LOT 138110 ((B)(6)) AND BEARING IMPLANT AR-503-BD12 LOT 113601219 ((B)(6)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A FEMALE, DOB (B)(6) 1952. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED THAT EXAMINATION OF THE RIGHT KNEE DEMONSTRATED SWELLING. PALPATION OF THE RIGHT KNEE DEMONSTRATED INFERIOR PATELLAR POLE TENDERNESS, MEDIAL TIBIAL PLATEAU TENDERNESS AND LATERAL TIBIAL PLATEAU TENDERNESS. PATIENT HAD PAIN WITH FLEXTION BUT NO PAIN WITH EXTENSION. RECORDS NOTED THE X-RAYS SHOWED PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING. MEDICAL RECORDS ALSO NOTED THAT A BONE SCAN WAS PERFORMED. RESULTS HAVE BEEN REQUESTED.

  Patient problems: Pain; Swelling

  MAUDE report 6078387 ↗
• InjuryOct 27, 2016Nonstandard Device; Device Slipped

  IT WAS REPORTED THAT A PATIENT HAD A LEFT TKA PROCEDURE ON (B)(6) 2015. DUE TO TIBIAL LOOSENING THE SURGEON PERFORMED A REVISION LEFT TKA ON (B)(6) 2016. DURING THE REVISION THE SURGEON EXPLANTED THE FOLLOWING ORIGINAL IMPLANTS: TIBIAL TRAY, AR-503-TTTC LOT 1227388 ((B)(4)). FEMORAL IMPLANT, AR-516-3L LOT 108761422 ((B)(4)) AND BEARING IMPLANT, AR-513-BC16 LOT 113601343 ((B)(4)). THE ARTHREX PATELLA IMPLANT, AR-504-PSB8 LOT 113601446 WAS NOT EXPLANTED. THE REVISION PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S PRODUCT. FEMALE PATIENT, (B)(6). PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PATIENT HAS PAIN IN THE LEFT KNEE THAT IS INCREASED WITH ACTIVITY AND WEIGHT BEARING. RECORDS ALSO NOTED PATIENT HAD INTERFERENCE WITH ACTIVITIES OF DAILY LIVING AND PAIN THROUGH A LIMITED PASSIVE RANGE OF MOTION WITH CREPITUS AND SWELLING. RECORDS NOTED X-RAYS SHOW PERIARTICULAR OSTEOPHYTES AND JOINT SPACE NARROWING.

  Patient problems: Loss of Range of Motion; Pain; Swelling

  MAUDE report 6060990 ↗
• InjuryAug 22, 2016Unstable

  IT WAS REPORTED THAT ON (B)(6) 2014, 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-TTTC (LOT 108761313) (B)(4)) AND BEARING IMPLANT AR-503-BC10 (LOT 113601218)(B)(4)). DURING THE REVISION PROCEDURE THE SURGEON IMPLANTED THE FOLLOWING ARTHREX PARTS: TIBIAL TRAY AR-513-T2 (LOT 10024438), BEARING IMPLANT AR-513-BC20 (LOT 113601352) AND STEM EXTENSION IMPLANT AR-523-10100 (LOT 10018099). PATIENT WAS A FEMALE, AGE (B)(6), DOB (B)(6)1962. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED PAIN WAS REPORTED AT (B)(6) WITH NO NEW INJURY. PATIENT HAVING ANTERIOR LEFT KNEE PAIN INCREASED IN TIBIAL PLATEAU REGION WITH WEIGHT BEARING. RECORDS INDICATE PATIENT REPORTED WALKING WAS PAINFUL WITH SOME INSTABILITY IN LEFT KNEE. DURING EXAMINATION PALPATION OF THE LEFT KNEE DEMONSTRATED MEDIAL TIBIAL AND LATERAL TIBIAL PLATEAU TENDERNESS. PATIENT WAS TENDER ON THE LEFT AT: ANTERIOR KNEE PAIN. MILD EFFUSION OF THE LEFT KNEE WAS NOTED. X-RAY FINDINGS REVEALED LEFT KNEE PROSTHESIS IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING OR STRESS SHIELDIN

  Patient problems: Pain

  MAUDE report 5893555 ↗
• InjuryJul 26, 2016Device Slipped; Unstable

  IT WAS REPORTED THAT ON (B)(6) 2014, PATIENT UNDERWENT A RIGHT TKA PROCEDURE DURING WHICH TIME THE PATELLA WAS NOT RESURFACED. ON (B)(6) 2016, THE SURGEON PERFORMED A REVISION RIGHT TKA PROCEDURE DUE TO LOOSE TIBIA AND FEMUR. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTC (LOT 982771), FEMORAL IMPLANT AR-503-PSRC (LOT 108761219) AND BEARING IMPLANT AR-503-BC10 (LOT 113601232). PATIENT, FEMALE, (B)(6). THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED DURING THE REVISION: TIBIAL TRAY AR-513-T1 (LOT 10018251), FEMORAL IMPLANT AR-516-1R (LOT 1355279), BEARING IMPLANT AR-513-BB16 (LOT 113601513), PATELLA IMPLANT AR-504-PSB8 (LOT 113601447) AND STEM EXTENSION IMPLANT AR-513-1050 (LOT 10018102). PATIENT MEDICAL RECORDS OF (B)(6) 2016 NOTED PATIENT REPORTED CHRONIC ANTERIOR KNEE PAIN, KNEE SWELLING WITH ACTIVITY, STAIRS ARE DIFFICULT AND EPISODES OF INSTABILITY OF KNEE. NO REPORT AT THAT TIME OF PAIN IN PLATEAU. EXAMINATION OF RIGHT KNEE DEMONSTRATED SWELLING. PALPATION OF THE RIGHT KNEE DEMONSTRATED INFERIOR PATELLAR POLE TENDERNESS BUT NO MEDIAL TIBIAL PLATEAU OR LATERAL TIBIAL PLATEAU TENDERNESS. MODERATE EFFUSION OF RIGHT KNEE, MODERATE CREPITUS WITH MOTIO

  Patient problems: Joint Swelling; Pain

  MAUDE report 5822774 ↗