Triathlon 5531-G-709-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327337464), received between Oct 15, 2020 and Aug 28, 2026 — classified as 15 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K172634); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

1. Feb 6, 2024Open, Classified

   Potential packaging breaches of inner blister and outer sterile blister.

   Z-1262-2024 · Root cause: Packaging · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient's Right knee was revised due to infection. A CR/ CS knee was removed and a TS knee with stems and augment was implanted. Rep confirmed that no further information will be released by the hospital or surgeon.

  Patient problems: Unspecified Infection

  MAUDE report 50499707 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: I&D WITH TIBIAL INSERT EXCHANGE DUE TO INFECTION. RIGHT KNEE TRIATHLON.

  Patient problems: Unspecified Infection

  MAUDE report 25527462 ↗
• InjuryNov 7, 2025Mechanical Problem; Mechanical Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LIMITED ROM CAUSED BY EXCESSIVE SCAR TISSUE. A DEBRIDEMENT WAS PERFORMED AND A 7X9 CS INSERT WAS EXCHANGED FOR ANOTHER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Scar Tissue

  MAUDE report 23500862 ↗
• InjuryOct 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REPORT IS FOR REVISION ON (B)(6) 2025. IN PROVIDING INFORMATION FOR A REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2025, REP PROVIDED A USAGE SHEET FOR A REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2025. REP REPORTED REVISION WAS DUE TO LIMITED ROM. THE SURGEON ORIGINALLY PLANNED TO CONVERT THE KNEE TO TRIATHLON HINGE, BUT OPTED TO CONVERT TO A TS KNEE WITH STEMS AND AUGMENTS INSTEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 23403217 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "DATE OF AWARENESS IS TODAY. PATIENT REVISED DUE TO POSSIBLE INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." A 7X9 CS INSERT WAS EXCHANGED FOR ANOTHER 7X9 CS INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 20470601 ↗
• MalfunctionFeb 14, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT THE INSERT WAS NOT SEATING POSTERIORLY. INSERT WAS WASTED AND A SECOND INSERT OBTAINED. THIS INSERT WAS ALSO NOT SEATING POSTERIORLY. THE INSERT HAD TO BE HELD IN PLACE AND GENTLY MALLETED IN. PROCEDURE COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN ONE MINUTE. TOURNIQUET WAS USED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702765 ↗
• MalfunctionFeb 14, 2024Difficult to Insert; Activation, Positioning or Separation Problem; Difficult to Insert; Activation, Positioning or Separation Problem

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT THE INSERT WAS NOT SEATING POSTERIORLY. INSERT WAS WASTED AND A SECOND INSERT OBTAINED. THIS INSERT WAS ALSO NOT SEATING POSTERIORLY. THE INSERT HAD TO BE HELD IN PLACE AND GENTLY MALLETED IN. PROCEDURE COMPLETED SUCCESSFULLY WITH A DELAY OF LESS THAN ONE MINUTE. TOURNIQUET WAS USED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702763 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION ON (B)(6) 2022. IN REPORTING A REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2022 THE REP PROVIDED USAGE SHEET INDICATING THE PATIENT HAD A PRIOR REVISION ON (B)(6) 2022. THE REASON FOR THE REVISION WAS AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18501015 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS STATUS POST I&D WASHOUT AND POLY EXCHANGE DUE TO LEFT KNEE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 18279594 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE REVISION/I&D. THE REVISION TODAY WAS SECONDARY TO INFECTION. THE INSERT WAS REMOVED TO MAKE ROOM TO WASHOUT THEN A NEW INSERT WAS PLACED. NO FURTHER INFORMATION IS AVAILABLE FROM THE SURGEON OR HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 17938849 ↗
• InjuryApr 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "PATIENT HAD LEFT TKA. FOLLOWING THIS PROCEDURE THE PATIENT HAD ACUTE MENTAL STATUS CHANGES AND WORD FINDING DIFFICULTY. MRI BRAIN SHOWED A SUBDURAL HEMATOMA FOR WHICH THE PATIENT WAS EVALUATED BY NEUROLOGY. REPEAT MRI BRAIN STABLE. DISCHARGED TO A REHAB FACILITY. DURING THE AFTERNOON OF (B)(6) 2023, THE PATIENT WAS ATTEMPTING TO AMBULATE TO THE RESTROOM AND "WOKE UP ON THE FLOOR". HE DOES NOT BELIEVE THAT HE HIT HIS HEAD. HE PRESENTED TO THE EMERGENCY DEPARTMENT AT UNIVERSITY HOSPITAL ON (B)(6) 2023 EXHIBITING SOME WORD FINDING DIFFICULTY. HE DID NOT HIT HEAD, NO LOC, NO CP/SOB IMMEDIATELY PRE- OR POST- FALL. THE PATIENT FELT PAIN IN LEFT KNEE FOLLOWING THE FALL WITH TRAUMATIC ARTHROTOMY AND DEHISCENCE OF ALMOST ALL OF HIS SURGICAL SITE. PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT SUCCESSFUL LEFT KNEE WASHOUT PROCEDURE WITH LINER CHANGE. THE PATIENT TOLERATED THE PROCEDURE WELL AND HAD AN UNEVENTFUL RECOVERY. THE PATIENT DECIDED THAT HE WISHED TO CONTINUE WITH WARFARIN AS HIS CURRENT AC REGIMENT RATHER THAN ELIQUIS. HE WAS PLANNED FOR DISCHARGE ON (B)(6) HOWEVER WAS FOUND TO BE SIGNIFICANTLY ORTHOSTATIC. POSSIBLE OFFENDING MEDICATIONS INCLUDING

  Patient problems: Fall; Pain

  MAUDE report 16797183 ↗
• InjuryMar 16, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "POLY SWAP DUE TO EXTENSOR MECHANISM REPAIR.

  Patient problems: Insufficient Information

  MAUDE report 16560538 ↗
• InjuryFeb 15, 2023Adverse 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 BECAUSE THE PATIENT WAS TIGHT IN FLEXION. A 7 CR FEMUR AND 7X9 CS INSERT WERE EXCHANGED.

  Patient problems: Loss of Range of Motion

  MAUDE report 16382957 ↗
• MalfunctionAug 12, 2021Fitting Problem; Fitting Problem

  7X9MM POLY INSERT HAD SMALL DEFECT. SMALL PIECE OF PLASTIC WAS PROTRUDING INTO NOTCH AREA FROM ANTERIOR LATERAL ASPECT OF INSERT. SURGICAL DELAY = 15 MINUTES. CASE TYPE / APPLICATION: TKA. UPDATE 19-JULY-2021 (B)(6): AS PER MPS RESPONSE: "I WAS PRESENT DURING THE CASE AS WAS ((B)(6) SALES REP). UPON LEAVING THE ROOM TO GET ANOTHER INSERT, SURGEON VERY CAREFULLY REMOVED PROTRUDING PIECE OF PLASTIC WITH A SCALPEL AND SUCCESSFULLY GOT THE IMPLANT DOWN AND LOCKED SECURELY IN PLACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312016 ↗
• MalfunctionJul 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PRIMARY KNEE PROCEDURE, WHEN THE INSERT WAS REMOVED DURING THE PACKAGING, THE SURGEON NOTED THE LOCKING WIRE WAS DISENGAGED FROM THE POLYETHYLENE. THE DEVICE WAS REMOVED FROM THE FIELD WITHOUT CONTACT THE PATIENT. A SECOND DEVICE WAS USED TO COMPLETE THE SURGERY WITH NO DELAY. A REP WAS PRESENT FOR AND WITNESSED THE EVENT. THE USAGE SHEET WITH THE WASTED DEVICE NOTED AND PICTURES WERE PROVIDED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12116175 ↗
• InjuryMay 28, 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 THE DEVELOPMENT OF A HEMATOMA. SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT AND DECIDED TO EXCHANGE THE POLY FOR ONE OF THE SAME CATALOG NUMBER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Hematoma

  MAUDE report 11900685 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. PERFORMED AN I&D INSERT EXCHANGE ON A LEFT TOTAL KNEE ORIGINALLY DONE WITH MAKO ON (B)(6) 2020 DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 11131883 ↗
• InjuryOct 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR KNEE 2 OF 2. PATIENT RECEIVED BILATERAL TKAS ON (B)(6) 2020. PATIENT SOUGHT CARE FOR PAINFUL SURGICAL SITES AND WAS SCHEDULED FOR AN I&D FOR BOTH KNEES. BOTH INSERTS WERE EXCHANGED FOR SAME SIZES AFTER WASHOUT AND ANTIBIOTICS.

  Patient problems: Pain

  MAUDE report 10683260 ↗
• InjuryOct 15, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR KNEE 1 OF 2. PATIENT RECEIVED BILATERAL TKAS ON (B)(6) 2020. PATIENT SOUGHT CARE FOR PAINFUL SURGICAL SITES AND WAS SCHEDULED FOR AN I&D FOR BOTH KNEES. BOTH INSERTS WERE EXCHANGED FOR SAME SIZES AFTER WASHOUT AND ANTIBIOTICS.

  Patient problems: Pain

  MAUDE report 10682293 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K172634. One submission often covers many models, so check the product and lot details in each record.

• Z-1263-2024 · Feb 6, 2024 · Open, Classified
  NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1265-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1264-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1654-2023 · Apr 13, 2023 · Open, Classified
  TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E