Triathlon 5531-G-411Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 07613327045789), received between Nov 13, 2017 and Mar 29, 2024 — classified as 27 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unstable” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2024Degraded; Unstable; Degraded; Unstable

  REVISED A TIBIAL INSERT OF A RIGHT TRIATHLON DUE TO INSTABILITY, POSTERIOR-MEDIAL POLY WEAR. HE UPSIZED FROM A 4X11 TO A 4X16 CS. NO ALLEGATIONS AGAINST THE IMPLANT MADE.

  Patient problems: Joint Laxity

  MAUDE report 19002747 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS STATUS POST REV RTKA DUE TO RIGHT KNEE INFECTION. DETAILS FROM ORIGINAL SURGERY UNKNOWN. NO ADDITIONAL DETAILS WERE PROVIDED BY THE FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 18873034 ↗
• InjuryFeb 2, 2024Fracture; Naturally Worn; Fracture; Naturally Worn

  PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND GLOBAL INSTABILITY. INTRA-OPERATIVELY, THE POSTERIOR MEDIAL LIP OF THE INSERT WAS OBSERVED TO BE WORN AND BROKEN IN 2 PIECES. THE PATIENT'S CS KNEE WAS REVISED TO A TS KNEE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 18632281 ↗
• InjuryOct 3, 2022Unstable; Unstable

  TIBIAL BEARING POLY SWAP RIGHT TOTAL KNEE DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 15527145 ↗
• InjurySep 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS PART OF THE MEDICAL REVIEW FOR THIS PATIENT IT WAS REPORTED THAT MANIPULATION UNDER ANESTHESIA TOOK PLACE ON THE (B)(6) 2018.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 15444070 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED LEFT KNEE REVISION ON (B)(6) 2020 DUE TO LOSS OF MOBILITY. PATIENT IS INQUIRING IF ANY PARTS WERE SUBJECT TO A RECALL.

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

  MAUDE report 14838299 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED "THIS PATIENT HAD FUNCTIONAL LOSS DUE TO ARTHROFIBROSIS 8 WEEKS POSTOPERATIVELY. AT (B)(6) 2022 THE PATIENT WAS HOSPITALIZED TO PERFORM MANIPULATION UNDER ANESTHESIA." UPDATE - NO EXPLANT OR REVISION SURGERIES WERE DONE OR PLANNED.

  Patient problems: Fibrosis

  MAUDE report 13541402 ↗
• InjurySep 8, 2021Naturally Worn; Naturally Worn

  THE FOLLOWING WAS REPORTED: REVISION DUE TO POLY WEAR.

  Patient problems: Insufficient Information

  MAUDE report 12441490 ↗
• InjuryMar 12, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ANTERIOR KNEE PAIN AND INSTABILITY (REPORTED BY SURGEON AS BEING A LITTLE LAX IN VARUS / VALGUS CONSTRAINT). THE SURGEON RESURFACED THE PATIENT'S NATIVE PATELLA AND EXCHANGED A 4X11 CR INSERT FOR A 4X14 CR INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 11474316 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. REVISED A TRIATHLON CS INSERT ORIGINALLY DONE WITH MAKO ON (B)(6) 2019 DUE TO INFECTION. LEFT KNEE. HE UPSIZED FROM A 4X11 TO A 4X12 WHILE HE WAS IN DOING THE I&D BECAUSE HE SAID IT FELT BETTER. UPDATE (B)(6) 2021: REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11242139 ↗
• InjuryJun 29, 2020Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  INFORMATION RECEIVED IN FOLLOW-UP INCLUDES AN OPERATIVE REPORT FOR A RIGHT KNEE REVISION ON (B)(6) 2018. NOTED IN THE RECORDS ARE THE FOLLOWING: "HAD A FALL. SHE IS NOW HAVING SYMPTOMS OF PAIN AND PRESENTED TODAY FOR OPERATIVE INTERVENTION. FAILED RIGHT KNEE ARTHROPLASTY WITH PATELLAR LOOSENING, INSTABILITY, AND EXTENSOR MECHANISM COMPROMISE. THE PATIENT'S PATELLAR COMPONENT WAS GROSSLY LOOSE AND FREE-FLOATING." A CR FEMUR, CS INSERT, AND TRIATHLON PATELLA WERE REVISED TO A TS FEMORAL COMPONENT WITH A STEM AND 4 AUGMENTS, A PS INSERT, AND A COMPETITOR PATELLA.

  Patient problems: Fall; Injury; Pain

  MAUDE report 10206341 ↗
• InjuryFeb 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IN WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. A 4X11 CS INSERT WAS EXCHANGED FOR A 4X19 CS INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9728246 ↗
• InjuryNov 27, 2019Unstable; Unstable

  THE DOCTOR REVISED A TRIATHLON TIBIAL INSERT ON A TOTAL KNEE DONE ORIGINALLY AT KENT HOSPITAL ON (B)(6) 2015 BY ANOTHER SURGEON. THE PATIENT WAS UNSTABLE, SO HE UPSIZED FROM A 4X11 TO A 4X16 INSERT. HE ALSO RESURFACED THE PATELLA WHICH WAS NOT ORIGINALLY DONE. THE INSERT THAT WAS REVISED SHOWED NO SIGNS OF WEAR, NO IMPLANTS WERE LOOSE.

  Patient problems: Injury

  MAUDE report 9385722 ↗
• InjuryNov 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. REVISED A TRIATHLON INSERT DUE TO POSSIBLE INFECTION. HE PERFORMED AN I&D. ORIGINAL SURGERY WAS MAKO ON (B)(6) 2019. UPDATE 30/OCTOBER/2019: REP PROVIDED PRIMARY AND REVISION USAGE SHEETS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9382989 ↗
• InjuryNov 26, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 4X11 CS INSERT WAS REVISED. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9375466 ↗
• InjurySep 19, 2019Unstable; Unstable

  PATIENT ORIGINALLY HAD A RIGHT TOTAL KNEE DONE BY DR ON (B)(6) 2016. NOW NEEDS REVISED DUE TO PAIN AND INSTABILITY.

  Patient problems: Injury; Pain

  MAUDE report 9087574 ↗
• MalfunctionAug 28, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, DURING A TKA, AFTER LOCKING THE INSERT, A SURGEON NOTICED A GAP(1MM LATERAL/POSTERIOR) BETWEEN THE INSET AND BASEPLATE. THEREFORE, HE TRIED TO INSERT ANOTHER SIZE INSERT BUT IT WAS ALSO SAME CONDITION. THE SECOND STAYED IMPLANTED. UPDATE: THE DELAY TIME WAS ABOUT 2-3 MINUTES. RIGHT SIDE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8939443 ↗
• InjuryJul 29, 2019Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. A 4X11 CS INSERT AND SYMMETRIC POLY PATELLA WERE REVISED TO A 4X14 CS INSERT AND ASYMMETRIC PATELLA. SURGEON NOTED UNUSUAL WEAR OF THE INSERT AND IS REQUESTING A WEAR ANALYSIS.

  Patient problems: Injury; Pain

  MAUDE report 8837176 ↗
• MalfunctionJul 18, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT WHEN THE IMPLANT WAS OPENED, BLACK SPECKS WERE OBSERVED ON THE DEVICE. ALL BUT ONE WAS ABLE TO BE WIPED OFF, THE ONE REMAINING SEEMS TO BE INFUSED IN THE POLY. DUE TO STERILITY CONCERNS, THE DEVICE WAS NOT USED. A SECOND DEVICE WAS IMMEDIATELY AVAILABLE AND SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. REP REPORTED THAT THE DEVICE AND PACKAGING ARE AVAILABLE FOR RETURN. NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8804337 ↗
• InjuryJul 2, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "INSTABILITY OF LEFT TOTAL KNEE ARTHROPLASTY." UPDATE 08 AUGUST, 2019: MEDICAL REVIEW HAS IDENTIFIED ADDITIONAL INFO: PRIMARY LEFT TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON (B)(6) 2010, USING A TRIATHLON CR KNEE WITH 11-MM X3 CS INSERT ON A PRIMARY BASEPLATE. THE FIRST YEAR POSTOPERATIVE WENT REASONABLY WELL BUT PATIENT PRESENTED AGAIN TO SURGEON ON (B)(6) 2012, WITH PROGRESSIVE LEFT KNEE PAIN, A ¿WEAK KNEE¿ WITH FEELINGS OF GIVING WAY AND ¿POPPING¿ SENSATIONS. UPON PHYSICAL EXAMINATION ¿NO GROSS INSTABILITY¿ WAS REPORTED ALTHOUGH SUBTLE INSTABILITY SIGNS WERE STILL NOTED. A DECISION FOR REVISION WITH EXCHANGE OF THE BEARING WAS ESTABLISHED AND PERFORMED ON (B)(6) 2012, WITH EXCHANGE OF THE 11-MM CS BEARING FOR A 16-MM CS BEARING WHILE RETAINING FEMUR AND TIBIA. MED REVIEW ALSO IDENTIFIED 2 SUBSEQUENT REVISION OF THIS PATIENTS KNEE. THIS PI IS FOR REVISION OF THE PRIMARY IMPLANTED ON (B)(6) 2010 AND REVISED ON (B)(6) 2012.

  Patient problems: Injury

  MAUDE report 8752772 ↗
• InjuryJun 11, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO " FAILED RIGHT TOTAL KNEE ARTHROPLASTY FOR INSTABILITY."

  Patient problems: Injury

  MAUDE report 8687092 ↗
• InjuryFeb 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. UPDATE (B)(4) 2019: CORRECTION TO THE ABOVE, REVISION WAS FOR PATIENT'S RIGHT KNEE AS PER REVISION IMPLANT SHEET ON (B)(6) 2019. A SIZE 4 RIGHT CR FEMUR AND 4X11 CS INSERT WAS REVISED TO A SIZE 3 RIGHT TS FEMUR WITH 12X50 STEM AND A 4X9 PS INSERT.

  Patient problems: Injury

  MAUDE report 8369952 ↗
• InjuryFeb 13, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSUFFICIENT FLEXION. THE SURGEON PERFORMED A DEBRIDEMENT AND POLY SWAP OF A 4X11 CS INSERT. THERE WERE NO DEFECTS OF THE REVISED INSERT OBSERVED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8336470 ↗
• InjuryJan 15, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FLEXION CONTRACTURE (COULD NOT BEND HER KNEE DUE TO SOFT TISSUE IMPINGEMENT). A SIZE 4 TRIATHLON CR FEMORAL COMPONENT AND SIZE 4 TRIATHLON CS INSERT WERE REVISED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8249107 ↗
• InjuryJan 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFECTION LEFT KNEE. UPDATE 10/DECEMBER/2018: REP INDICATED A DATE OF EXPLANT, INDICATING REVISION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8217977 ↗