Triathlon 5531-G-609Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07613327045932), received between Oct 5, 2017 and Mar 5, 2025 — classified as 40 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (18 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 42 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D WITH TIBIAL INSERT EXCHANGE ON A LEFT KNEE DUE TO INFECTION. WHILE HE WAS IN THERE, HE DECIDED TO GO UP FROM 6X9 TO 6X11 FOR MORE STABILITY.

  Patient problems: Unspecified Infection

  MAUDE report 21525145 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE - POLY SWAP FROM PREVIOUS SURGERY. REASON FOR REVISION: PCL RUPTURE. ORIGINAL IMPLANT: 6X9 CS POLY. NEW IMPLANT: 6X13 CS POLY.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 20277160 ↗
• InjurySep 11, 2024Adverse 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 PATIENT COMPLAINT OF PATELLAR PAIN. THE PATIENT'S NATIVE PATELLA WAS RESURFACED, AND A 6X9 CS INSERT WAS EXCHANGED FOR ANOTHER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 20189526 ↗
• InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION. A 6X9 CS INSERT WAS EXCHANGED FOR ANOTHER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 20124010 ↗
• InjuryFeb 20, 2024Mechanical Problem; Unstable; Mechanical Problem; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. SURGEON NOTED THAT THE TIBIA WAS IN EXTERNAL ROTATION, BUT FELT IT WASN'T ENOUGH TO REVISE THE BASEPLATE. A 6X9 PS INSERT WAS REVISED TO A 6X12 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 18737373 ↗
• InjurySep 18, 2023Degraded; Naturally Worn; Degraded; Naturally Worn

  DURING A KNEE REVISION, THE SURGEON NOTICED A HORIZONTAL LINE/GROOVE ON THE MEDIAL SIDE OF A #6 LEFT CR CEMENTED FEMORAL COMPONENT. THE SURGEON ALSO NOTICED EXTREME WEAR ON THE MEDIAL SIDE OF A#6 9MM CS POLY INSERT AND WEAR ON THE SYMMETRICAL 39X11MM PATELLA. WHILE REMOVING THE LEFT FEMORAL COMPONENT FROM THE PATIENT'S FEMUR, THE SURGEON WAS ABLE TO REMOVE THE BROKEN FEMORAL SECTION OF THE COMPONENT. FEMORAL COMPONENT, TIBIAL POLY INSERT AND THE PATELLA WERE REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 17762846 ↗
• InjuryFeb 3, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: PATIENT HAD BILATERAL MANIPULATION UNDER ANESTHESIA. ONLY RIGHT KNEE IMPLANTS WERE PROVIDED. THIS PI IS FOR THE PATIENT'S RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 16289995 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPLACED A TRIATHLON TIBIAL INSERT OF A LEFT KNEE FROM A 6X9 TO A 6X10 CS. REVISION DUE TO SOFT TISSUE LAXITY. NO ALLEGATIONS AGAINST THE IMPLANTS.

  Patient problems: Joint Laxity

  MAUDE report 14700749 ↗
• InjuryJun 13, 2022Malposition of Device; Naturally Worn; Malposition of Device; Naturally Worn

  REVISED A PRIMARY RIGHT KNEE TRIATHLON DUE TO MIS-BALANCING RESULTING IN MEDIAL POLY WEAR AND FEMUR RUBBING ON TIBIAL BASEPLATE. HE REVISED THE FEMUR, TIBIAL BASEPLATE AND POLY TO A COMPETITOR REVISION TOTAL KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14682459 ↗
• InjuryApr 25, 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: "SUBJECT IS STILL PROGRESSING WELL REGARDING HIS RIGHT KNEE; HOWEVER, HE DOES EXPERIENCE SOME BILATERAL KNEE SORENESS WHEN WALKING LONG DISTANCES. THIS DOES NOT USUALLY INTERFERE WITH HIS DAILY ACTIVITIES. THE SUBJECT ALSO REPORTED SOME CONTINUED INTERMITTENT BACK PAIN." THERE IS NO INDICATION THE PATIENT HAS BILATERAL KNEE REPLACEMENTS.

  Patient problems: Pain

  MAUDE report 14191578 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "BEHIND THE KNEE - SOME PAIN. LESS STIFFNESS AND PAIN BUT HEARS CLICKING AND FEELS LOOSE. RECENT DOCTOR VISIT/ X-RAYS CONFIRM JOINT IS FINE."

  Patient problems: Pain

  MAUDE report 14187054 ↗
• InjuryFeb 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TEXT FROM SITE EMAIL EVENT DESCRIPTION- "SAE HAPPENED IN SUBJECT (B)(6) AT (B)(6) 2021. THIS PATIENT HAD A POSTOPERATIVE HEMATOMA AND CAME AT THE EMERGENCY ROOM. AFTER APPLYING PRESSURE BANDAGES AND PRESCRIBING OXYCODON, THE PATIENT WAS DISCHARGED. AT (B)(6) 2021 THE PATIENT HAD NUMBNESS IN HIS LEG, BUT THERE WERE NO ADDITIONAL ACTIONS. AT (B)(6) 2021 THE PATIENT HAD TINGLING SENSATION IN BOTH THE LEG AND FOOT AND FUNCTIONAL LOSS OF THE KNEE. THE PATIENT WAS REFERRED TO THE NEUROLOGIST BECAUSE OF EXPECTED ENTRAPMENT OF THE N. ISCHIADICUS." UPDATE 20-JUL-2022 MF: EMAIL ATTACHMENT COMMUNICATION INDICATES "THE NEUROLOGIST MADE A EMG. AFTER THAT, THIS PATIENT HAD FUNCTIONAL LOSS DUE TO ARTHROFIBROSIS. AT (B)(6) 2022 THE PATIENT WAS HOSPITALIZED TO PERFORM MANIPULATION UNDER ANAESTHESIA."

  Patient problems: Fibrosis; Hematoma; Numbness

  MAUDE report 13522875 ↗
• InjuryJul 22, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LIGAMENT LAXITY. A 6X9 CS INSERT WAS REVISED TO A 6X13 CS INSERT. REP PROVIDED AN EXPLANT PICTURE AND REVISION USAGE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 12211591 ↗
• InjuryJul 19, 2021Unstable; Unstable

  DR. REVISED A RIGHT KNEE TRIATHLON CS TIBIAL INSERT ORIGINALLY DONE WITH MAKO ON (B)(6) 2018. THIS WAS DUE TO STIFFNESS. HE DID SOFT TISSUE RELEASES AND PUT THE SAME SIZE INSERT BACK IN, A 6X9.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12193633 ↗
• InjuryApr 8, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. A 6X9 CS INSERT WAS REVISED TO A 6X12 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 11633190 ↗
• InjuryApr 6, 2021Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  LOOSENING OF TRIATHLON TIBIAL INSERT ( SIZE 6 9MM CS ) ORIGINALLY DONE (B)(6) 2019 (MAKO). TODAY A REPLACEMENT INSERT SIZE 6 11MM CS WAS PUT IN.

  Patient problems: Inadequate Osseointegration; Joint Laxity

  MAUDE report 11618040 ↗
• InjuryMar 18, 2021Adverse 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 DUE TO SUSPECTED INFECTION. A 6 X 9 TRIATHLON CS INSERT WAS SWAPPED FOR ANOTHER OF THE SAME TYPE AND SIZE. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11515232 ↗
• InjuryMar 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT MAKO KNEE WAS REVISED DUE TO SUSPECTED INFECTION. A WASHOUT AND EXCHANGE OF A 6X9 CS POLY FOR ANOTHER 6X9 CS POLY WAS PERFORMED. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11435346 ↗
• InjuryFeb 4, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. A CR FEMUR AND CS INSERT WERE REVISED TO A TS INSERT WITH AUGMENTS AND STEM, AND A PS INSERT. REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11283052 ↗
• InjuryJan 14, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY IN EXTENSION. A 6X9 CS INSERT WAS REVISED TO A 6X13 CS INSERT.

  Patient problems: Joint Laxity

  MAUDE report 11172621 ↗
• InjuryDec 20, 2020Unstable; Loss of Osseointegration; Unstable; Loss of Osseointegration

  PATIENT PRESENTED 14 MONTHS POST LEFT TOTAL KNEE REPLACEMENT WITH AN EFFUSION AND SWELLING. THE SWABS SHOWED NO INFECTION. THE DR SCOPED THE KNEE, WHERE HE DISCOVERED THAT THE POLY TIBIAL INSERT APPEARED LOOSE. HE IS PLANNING TO REVISE THE POLY IN LATE (B)(6) 2021.

  Patient problems: Inflammation; Joint Laxity

  MAUDE report 11043058 ↗
• InjuryNov 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A FIRST STAGE REVISION WAS PREFORMED ON THE PATIENT'S LEFT KNEE DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 10920329 ↗
• InjuryOct 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  REP REPORTED: "LEFT TOTAL KNEE REVISION PERFORMED PATIENT PRESENTED WITH AN INFECTED TKA, ORIGINAL SURGERY PERFORMED IN OCTOBER OF LAST YEAR. EXPLANTS ARE NOT AVAILABLE FOR RETURN AS PER HOSPITAL POLICY." A 7X 13 MM PS TIBIAL COMPONENT, SIZE 6 PS FEMORAL COMPONENT, AND SIZE A40 ASYMMETRIC PATELLA WERE IMPLANTED. REP CONFIRMED NO OTHER INFORMATION WILL BE RELEASED BY HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 10662818 ↗
• InjuryMar 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "SURGEON DID A POLY EXCHANGE ON A RIGHT KNEE. NO MORE INFORMATION IS AVAILABLE PER DOCTOR." REP PROVIDED THE PRIMARY USAGE SHEET WITH NOTE THAT REVISION WAS DUE TO INFECTION.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9903689 ↗
• InjuryJan 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN EXTENSIVE SOFT TISSUE DEBRIDEMENT WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO STIFFNESS. WHILE THIS WAS PERFORMED, SURGEON DECIDED TO SWAP THE 6X9 CS INSERT FOR ANOTHER 6X9 CS INSERT. PATIENT HAD A MUA IN (B)(6) 2019 DUE TO STIFFNESS AFTER PATIENT DID NOT GO TO PHYSICAL REHABILITATION, AND CONTRACTED LYME DISEASE AFTER THE PRIMARY IMPLANTATION. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE LINER, PROVIDED PRIMARY AND REVISION USAGE INFORMATION, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9588545 ↗