Triathlon 5531-G-509Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 07613327045871), received between Dec 7, 2017 and Oct 13, 2024 — classified as 39 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (14 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 41 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2024Unstable; Unstable

  REVISED A TRIATHLON RIGHT KNEE DUE TO INSTABILITY. HE REVISED FROM A 5X9 CS TO A 5X14 CS.

  Patient problems: Joint Laxity

  MAUDE report 20436451 ↗
• InjuryAug 8, 2024Degraded; Unstable; Degraded; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LIGAMENT LAXITY (CAUSED BY THE PATIENT RUPTURING HIS PCL AFTER A FALL). A 5X9 CS INSERT WAS REVISED TO A 5X14 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE PER VISUAL INSPECTION: THE DEVICE WAS NOT RETURNED; HOWEVER, PHOTOGRAPHS WERE PROVIDED FOR INSPECTION. THE PHOTOGRAPHS SHOW A RECENTLY EXPLANTED INSERT WITH SIGNS OF WEAR.

  Patient problems: Fall; Joint Laxity; Muscle/Tendon Damage

  MAUDE report 19939941 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO RANGE OF MOTION ISSUES. A 5X9 POLY SWAP WAS PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 18307626 ↗
• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT STATED THAT HE HAD A PRIMARY TRIATHLON LEFT KNEE IN (B)(6) 2015. HE STATED THAT HE HAS ONLY BEEN ABLE TO BEND HIS LEFT KNEE "VERY LITTLE" SINCE HIS SURGERY AND DID CONFIRM THAT HE DOES HAVE PAIN WHEN BENDING. PATIENT STATED HE OBTAINED TWO SECOND OPINIONS APPROX. THREE YEARS AGO IN WHICH BOTH DOCTORS STATED THAT THE "KNEE IS POSSIBLY TOO BIG" FOR HIM. PATIENT WOULD LIKE TO KNOW IF KNEE IS SUBJECT TO A RECALL.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 16552993 ↗
• InjuryFeb 27, 2023Degraded; Unstable; Degraded; Unstable

  THE FOLLOWING WAS REPORTED: KNEE REVISION DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 16442590 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: PATIENT HAD RIGHT KNEE MANIPULATION UNDER ANESTHESIA. NO FURTHER INFORMATION WAS PROVIDED TO THE CLINICAL TEAM.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16289996 ↗
• InjuryFeb 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE PATIENT'S LEFT KNEE. AS REPORTED: PATIENT HAD BILATERAL MANIPULATION UNDER ANESTHESIA. ONLY LEFT KNEE IMPLANTS WERE PROVIDED. NO FURTHER INFORMATION WAS PROVIDED TO THE CLINICAL TEAM.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16289919 ↗
• InjuryDec 19, 2022Unstable; Naturally Worn; Unstable; Naturally Worn

  REVISED A TRIATHLON INSERT. DR. SAID THE PATIENT RUPTURED THEIR PCL AT SOME POINT AND IT CAUSED POSTERO-LATERAL POLY WEAR AND INSTABILITY. HE REVISED FROM A 5X9 TO A 5X11.

  Patient problems: Joint Laxity; Rupture

  MAUDE report 16011467 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. A SIZE 6 LEFT CEMENTED CR FEMUR, SIZE 5 CEMENTED BASEPLATE, 5X9 CS INSERT, AND 35MM PATELLA (ALL TRIATHLON) WERE REVISED. REP CAN PROVIDE PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 15903675 ↗
• InjurySep 9, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. A 5X9 INSERT WAS REVISED TO A 5X14 INSERT. REP CONFIRMED THAT NO IMPLANTS WERE REPORTED AS LOOSE OR BROKEN, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 15392852 ↗
• InjuryMay 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT, HE HAD A RIGHT TKA DONE ON (B)(6), 2020. PATIENT HAS BEEN EXPERIENCING PAIN SINCE HIS SURGERY. HE HAS PROBLEMS URINATING, UNABLE TO LAY DOWN AND HAS TO SLEEP ON A RECLINER AND HE'S EXPERIENCING POPPING. HIS PAIN HAS NEVER STOPPED.

  Patient problems: Pain; Urinary Retention

  MAUDE report 14257963 ↗
• InjuryApr 25, 2022Unstable; Unstable

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "SWOLLEN KNEE. UNSTABLE WHEN GETTING UP. DIFFICULTY WITH PUTTING ON SOCKS, TYING SHOES LACES; AND GETTING OUT OF DEEP CHAIRS."

  Patient problems: Ambulation or Postural Difficulties; Swelling/ Edema

  MAUDE report 14192295 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "PAIN DESPITE REPEATED PHYSICAL THERAPY CONTINUES IN MY KNEE. SEVERE PAIN WITH KNEELING AND AMBULATING. PATIENT STATES SURGERY WAS A "DISASTER". CONSTANT THROBBING PAIN THAT VARIES IN INTENSITY BASED ON ACTIVITY. PATIENT CONTINUES TO HAVE THE SAME PAIN BEFORE KNEE REPLACEMENT."

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 14187052 ↗
• InjuryJan 14, 2022Unstable; Unstable

  RIGHT KNEE REVISED FOR INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 13257869 ↗
• InjuryJan 5, 2022Fracture; Fracture

  THE FOLLOWING WAS REPORTED: "PATIENT TREATED FOR PTG REVISION BECAUSE OF UNSTABLE PROSTHESIS, THE POLYETHYLENE IN PLACE WAS BROKEN. SURGICAL REVISION."

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 13169812 ↗
• InjuryDec 20, 2021Fracture; Fracture

  IT WAS REPORTED: "2 YEARS-OLD X3 INSERT ARE BROKEN ON THE BACK SIDE."

  Patient problems: Insufficient Information; Pain

  MAUDE report 13049289 ↗
• InjuryOct 13, 2021Material Discolored; Fracture; Unstable; Material Discolored; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO SLIGHT INSTABILITY. THE PATIENT'S NATIVE PATELLA WAS RESURFACED AND A POLY EXCHANGE WAS PERFORMED. IT WAS NOTICED THAT THE REVISED INSERT WAS DISCOLORED WHERE IT CAME INTO CONTACT WITH THE FEMORAL COMPONENT (SURGEON REPORTED THE DISCOLORATION AS OXIDATION, NO DISCOLORATION OF ANY KIND NOTED ON THE FEMORAL COMPONENT). SURGEON WOULD LIKE THE DEVICE INVESTIGATED TO DETERMINE THE CAUSE OF THE DISCOLORATION, AND WOULD LIKE THE RESULTS. REP REPORTED THE DEVICE IS ALLEGEDLY AVAILABLE FOR RETURN. REP CONFIRMED HE MAY BE ABLE TO PROVIDE PICTURES/ USAGE, AND THAT OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 12623642 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT SHE HAD A RIGHT TKA DONE ON (B)(6) 2019 AND EXPERIENCED SEVERE ELECTRICAL BURN DUE TO THE ROBOTIC ARM USED. PATIENT STATED THE 2 DAYS AFTER THE SURGERY SHE STARTED TO GET BIG BLISTERS ON HER LEG. A WEEK AFTER THE SURGERY SHE WAS IN THE EMERGENCY ROOM DUE TO THE BLISTERS. PATIENT WAS SENT TO THE WOUND CARE CLINIC FOR APPROX A MONTH. PATIENT STARTED TO EXPERIENCE PAIN IN (B)(6) 2020. THE PATIENT WENT TO SEE HER SURGEON 3 WEEKS AGO AND WAS TOLD TO GET AN MRI. PATIENT IS MAINLY LOOKING FOR THE CATALOG, SERIAL AND LOT OF THE ROBOTIC ARM.

  Patient problems: Blister; Pain

  MAUDE report 12150059 ↗
• InjuryJul 1, 2021Unstable; Unstable

  AS REPORTED: "REVISED A CS TRIATHLON INSERT 5X9 TO ANOTHER 5X9 DUE TO ARTHROFIBROSIS AND SCAR TISSUE. PATIENT WAS TIGHT." REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12104456 ↗
• InjuryNov 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION THAT THE PATIENT'S RIGHT KNEE WAS REVISED. A SIZE 5 RIGHT CR FEMUR AND 5X9 CS INSERT WERE REVISED TO A SIZE 6 RIGHT TS FEMUR WITH A STEM AND 4 AUGMENTS AND A 5X13 PS INSERT.

  Patient problems: Insufficient Information

  MAUDE report 10779500 ↗
• InjuryJun 29, 2020Unstable; Unstable

  DR. (B)(6) REVISED A TRIATHLON CS TIBIAL INSERT DUE TO BEING UNDERSIZED. THE ORIGINAL SURGERY WAS DONE ON (B)(6) 2019. DOCTOR CHANGED FROM A 5X9 TO A 5X11. THE PATIENT REPORTED INSTABILITY.

  Patient problems: Injury

  MAUDE report 10206336 ↗
• InjuryApr 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. WHILE PERFORMING A PATELLA TENDON REPAIR OF A MAKO KNEE IMPLANTED IN (B)(6) 2020, THE SURGEON DECIDED TO REVISE THE LINER. REP CONFIRMED THERE WERE NO ALLEGATIONS AGAINST THE LINER, AND THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 10014439 ↗
• InjuryJan 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT'S RIGHT LEG WAS REVISED TO A TRIATHLON TS DUE TO INFECTION. ALL THE INFORMATION THE FACILITY HAS ON THE PATIENT'S IMPLANTS ARE ATTACHED TO THIS EMAIL. ALL IMPLANTS WERE EXPLANTED." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9569534 ↗
• InjuryNov 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  BASED ON THE MEDICAL REVIEW IN PI, IT WAS REPORTED THAT AT 2-MONTHS POSTOP ON (B)(6) 2011, THE PATIENT'S KNEE CONDITION REMAINED POOR WITH 8/10 VAS PAIN AND UNCHANGED POOR 20° ROM. UNDER A DIAGNOSIS OF ARTHROFIBROSIS, A MANIPULATION OF THE KNEE UNDER ANAESTHESIA (MUA) WAS PERFORMED ON (B)(6) 2011.

  Patient problems: Injury; Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 9377330 ↗
• InjuryNov 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. A 5X9 CS INSERT AND SIZE 6 CR FEMUR WERE REVISED TO A SIZE 5 TS FEMUR WITH 12X100 STEM AND 5X11 PS INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 9316068 ↗