Triathlon 5532-G-511Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07613327050783), received between Sep 28, 2017 and Mar 24, 2026 — classified as 20 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION SURGERY OF A LEFT TOTAL KNEE. THE INDEX CASE WAS WITH MANUAL INSTRUMENTS. THE PATIENT PRESENTED RECENTLY WITH CLICKING IN HIS KNEE AND PAIN. IT WAS DISCOVERED DURING SURGERY THAT THE PS POST HAD BROKEN OFF OF THE INSERT. THIS INSERT WAS REMOVED AND A TS INSERT WAS PLACED. IT WAS DECIDED TO USE A TS INSERT FOR THE ADDED STABILITY OF THE METAL POST IN THE INSERT. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Insufficient Information; Pain

  MAUDE report 24678363 ↗
• InjurySep 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT AT SOME POINT IN THE PAST YEAR, THE PS POST SEPARATED FROM THE INSERT AND THE INSERT FROM THE TIBIAL BASEPLATE WHILE IN THE PATIENT. FRACTURED INSERT. THE INITIAL SURGERY WAS DONE FOR RIGHT TKA ON (B)(6)2019. THE REVISION SURGERY WAS DONE (B)(6).

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 20133844 ↗
• InjuryJun 4, 2024Unstable; Unstable

  IT WAS REPORTED THAT A PATIENT RECEIVED TOTAL KNEE REVISION DUE TO A GLOBALLY UNSTABLE RIGHT KNEE. NO ADDITIONAL INFORMATION PROVIDED BY THE FACILITY.

  Patient problems: Joint Laxity

  MAUDE report 19464213 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY RIGHT TKA ON (B)(6), 2013. PATIENT PRESENTED WITH PAIN AND SIGNS OF PJI. WAS REVISED ON (B)(6), 2022. ALL COMPONENTS EXCHANGED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15968172 ↗
• InjuryNov 11, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED FOR INSTABILITY CAUSED BY THE POST OF THE PS INSERT SHEARING OFF. THE INSERT WAS REVISED TO A TS INSERT.

  Patient problems: Joint Laxity

  MAUDE report 15785315 ↗
• InjuryJul 28, 2022Adverse 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 INFECTION. A 5X11 PS INSERT WAS REVISED TO A 5X10 PS INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 15119008 ↗
• InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A "CLEAN OUT" OF HIS RIGHT KNEE DUE TO INFECTION. IT IS UNKNOWN IF ANY COMPONENTS WERE EXCHANGED.

  Patient problems: Bacterial Infection; Pain; Synovitis; Unspecified Infection

  MAUDE report 14545713 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED 1ST OF 2 STAGE REVISION FOR INFECTION WHERE PARTS WERE REMOVED AND A SPACER WAS IMPLANTED.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 14520825 ↗
• InjuryApr 21, 2022Unstable; Noise, Audible; Unstable; Noise, Audible

  PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "KNEE ROCKS SIDE BECOMES SORE. CLICKS; CAN'T KNEEL DOWN." COORDINATOR NOTES THAT POLY EXCHANGE WAS RECOMMENDED AND NOTES: "I CONTACTED THE PATIENT AND HE SEEMS TO HAVE A LOT OF FEARS/ CONCERNS ABOUT THE PROCEDURE AND IF HE¿LL GET BETTER OR HAVE THE SAME OUTCOME. HE IS CONSIDERING HAVING A REVISION IN JANUARY AND WILL CALL WHEN HE¿S READY." PATIENT INDICATED NOT TO HAVE HAD SURGERY ON THE KNEE.

  Patient problems: Discomfort; Joint Laxity; Pain

  MAUDE report 14167171 ↗
• InjuryApr 20, 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: "RARELY PAIN. MORE TIGHTNESS AND STIFFNESS. WISH I WOULD HAVE FULL RANGE OF MOTION."

  Patient problems: Pain

  MAUDE report 14161916 ↗
• InjuryFeb 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POSTOPERATIVE SERRATIA INFECTION WAS CONFIRMED. TWO SERRATIA INFECTION OCCURRED. SINCE SERRATIA IS RARE, HE IS SUSPICIOUS OF THE STERILIZATION AND STORAGE CONDITIONS OF THE IMPLANTS. HE REQUEST AN IMMEDIATE INVESTIGATION AND REPORT ON STERILIZATION AND STORAGE PROCESS, AND WHETHER OR NOT THE SIMILAR EVENT HAS BEEN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 13545197 ↗
• InjuryNov 23, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN AND RANGE OF MOTION ISSUES. A PS FEMUR AND TIBIAL BASEPLATE (IMPLANTED (B)(6) 2019), AND 5X11 PS INSERT (IMPLANTED (B)(6) 2021) WERE REVISED TO A TS FEMORAL COMPONENT, 5X9 TS INSERT, AND UNIVERSAL BASEPLATE WITH AUGMENTS AND STEMS. REP PROVIDED THE REVISION USAGE AND EXPLANT PICTURES, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 12861593 ↗
• InjuryNov 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO PAINFUL TOTAL KNEE ARTHROPLASTY ON THE RIGHT.

  Patient problems: Injury; Pain

  MAUDE report 9285962 ↗
• InjurySep 3, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THERE ARE NO ALLEGATIONS AGAINST ANY OF THE PATIENT'S IMPLANTS. A 5X11 PS INSERT WAS REVISED TO A 5X13 TS INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8955547 ↗
• InjuryAug 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S RIGHT KNEE DUE TO INFECTION (INFECTION REPORTED BY SURGEON. UNKNOWN IF CLINICALLY CONFIRMED, INFECTING MICROORGANISM UNKNOWN). ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP REPORTED THAT NO FURTHER INFORMATION WILL AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8939437 ↗
• InjuryMar 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO INFECTION (INFECTION REPORTED BY SURGEON WITH PUS NOTED INTRA-OPERATIVELY. UNKNOWN IF CLINICALLY CONFIRMED, UNKNOWN INFECTING MICROORGANISM). A 5X11 PS POLY WAS SWAPPED FOR ANOTHER 5X11 PS POLY. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8440954 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PROCEDURE: THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2017. PATIENT UNDERWENT KNEE REVISION TO TREAT PAIN AND ARTHROFIBROSIS. THE LINER EXCHANGED AND ALL OTHER COMPONENTS WERE RETAINED ON (B)(6) 2018".

  Patient problems: Injury; Pain

  MAUDE report 7970363 ↗
• InjuryMay 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT IS STATUS POST OP LEFT TOTAL KNEE ON (B)(6) 2017. HE SAW A NEW SURGEON WITH COMPLAINTS OF PAIN AND LIMITED RANGE OF MOTION. THE PATIENT WAS EVALUATED AND IT WAS DETERMINED HE HAD SCAR TISSUE AND LIMITED RANGE OF MOTION. THIS WAS MOST LIKELY DUE TO A DELAY IN GETTING PHYSICAL THERAPY AND PATIENT NON COMPLIANCE WITH THERAPY. HE WAS SCHEDULED FOR A REVISION POLY SWAP AND SCAR TISSUE REMOVAL. AT SURGERY THERE WAS SIGNIFICANT SCAR TISSUE WHICH WAS REMOVED. A NEW THINNER (9MM) POLY WAS INSERTED. PATIENT HAD IMPROVED RANGE OF MOTION. NO EVIDENCE OF LOOSENING OR WEAR WERE NOTED. THE OPERATION WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 7493563 ↗
• InjuryApr 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT HAD SWELLING OF [RIGHT] KNEE. DOCTOR REMOVED SOME SOFT TISSUE AND CHANGED POLY FROM 11MM TO 9MM".

  Patient problems: Injury; Swelling

  MAUDE report 7474865 ↗
• InjuryMar 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED (REASON NOT REPORTED). A POLY EXCHANGE WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 7323016 ↗
• MalfunctionSep 28, 2017Difficult To Position; Difficult To Position

  SURGEON BROKE A TIBIAL TRIAL INSERT DURING TRAILING. HE ALSO HAD TROUBLE SEATING THE REAL TIBIAL INSERT IMPLANT. HE FELT IT WAS NOT PROPERLY SEATED AND WASTED 2 INSERTS IN THE PROCESS. HE FELT THE MEDIAL SIDE WAS TIGHT AND WAS CAUSING THE INSERT TO GO IN AT AN ANGLE. SURGEON DID NOT FEEL THERE WAS ANYTHING WRONG WITH THE IMPLANTS. THE THIRD INSERT SEATED PROPERLY AND LOCKED IN TO THE TIBIAL TRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6900794 ↗
• MalfunctionSep 28, 2017Break; Break

  SURGEON BROKE A TIBIAL INSERT DURING TRAILING. HE ALSO HAD TROUBLE SEATING THE REAL TIBIAL INSERT IMPLANT. HE FELT IT WAS NOT PROPERLY SEATED AND WASTED 2 INSERTS IN THE PROCESS. HE FELT THE MEDIAL SIDE WAS TIGHT AND WAS CAUSING THE INSERT TO GO IN AT AN ANGLE. SURGEON DID NOT FEEL THERE WAS ANYTHING WRONG WITH THE IMPLANTS. THE THIRD INSERT SEATED PROPERLY AND LOCKED IN TO THE TIBIAL TRAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6900199 ↗