Triathlon 5531-G-209-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327336412), received between Jul 19, 2022 and Jul 9, 2026 — classified as 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unstable” (3 reports).

7 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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT REVISED DUE TO INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 25766428 ↗
• InjuryDec 3, 2025Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT SUSPECT PCL TORN.

  Patient problems: Damage to Ligament(s); Joint Laxity

  MAUDE report 23708909 ↗
• InjurySep 15, 2025Unstable; Unstable

  REVISED A RIGHT TRIATHLON INSERT FROM 2X9 CS TO 2X13 CS DUE TO INSTABILITY.

  Patient problems: Joint Laxity

  MAUDE report 23059320 ↗
• MalfunctionSep 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED: "POLY LOCKING WIRE FELL OFF PRIOR TO EVEN TRYING TO IMPLANT IT. WE WASTED THAT ONE AND OPENED ANOTHER ONE TO IMPLANT.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22973743 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D OF A RIGHT TRIATHLON KNEE DUE TO INFECTION. TIBIAL INSERT WAS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 22838642 ↗
• InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO NEW INFORMATION.

  Patient problems: Bacterial Infection

  MAUDE report 22836917 ↗
• InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REV RTKA W/ ANTIBIOTIC SPACER PLACEMENT FOR INFECTION." REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 22044028 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A LEFT KNEE INSERT DUE TO SCAR TISSUE AND LIMITED RANGE OF MOTION. HE REMOVED SCAR TISSUE AND RELEASED THE PCL.

  Patient problems: Loss of Range of Motion

  MAUDE report 21710745 ↗
• InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: "UPPER RESPIRATORY INFECTION LED TO KNEE INFECTION. PATIENT CAME IN FOR AN I&D AND POLY SWAP. EXCHANGED 2X9 CS POLYS."

  Patient problems: Unspecified Infection

  MAUDE report 21312193 ↗
• InjuryJan 6, 2025Mechanical Problem; Mechanical Problem

  REVISED A LEFT KNEE TIBIAL INSERT DUE TO STIFFNESS AND NOT FULL RANGE OF MOTION. HE RELEASED THE PCL AND SCAR TISSUE.

  Patient problems: Loss of Range of Motion

  MAUDE report 21081605 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISED A RIGHT TRIATHLON INSERT DUE TO THE NEED OF CLEARING SCAR TISSUE FOR BETTER RANGE OF MOTION FOR THE PATIENT.

  Patient problems: Adhesion(s)

  MAUDE report 20299369 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SOFT TISSUE/PCL RELEASE WITH TIBIAL INSERT EXCHANGE ON A PATIENT THAT HAD LIMITED RANGE OF MOTION. NO ALLEGATIONS AGAINST THE INSERT.

  Patient problems: Insufficient Information

  MAUDE report 19700274 ↗
• MalfunctionJun 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IMPLANT WAS OPENED, WHEN SURGEON HANDLED IT, UPON INSERTION IN TO THE PATIENT THE WIRE LOCKING MECHANISM POPPED OFF THE IMPLANT AND FELL ON THE FLOOR. THIS WAS AS THE IMPLANT WAS IMPACTED. IT APPEARED TO BE VERY LOOSE AS THE SURGEON IMPACTED IT AS HE USUALLY DOES AS PER THE OP TECH. THE WIRE SEEMED TO FALL OFF AT THE FIRST BIT OF IMPACTION WHICH WAS STRANGE. IT WAS APPARENT TO BOTH THE STRYKER REP AND SURGEON THAT SOMETHING SEEMED WRONG WITH THE IMPLANT AS THE LOCKING WIRE SHOULD NOT BE FALLING OUT OF THE POLY IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19455644 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT PATIENT CAME TO CLINIC WITH AN INFECTED RIGHT KNEE. SURGERY WAS DONE ON (B)(6) 2023 BY DR. TAI CHEH CHIN IN ADMC. INFECTED REASON UNKNOWN. SURGEON INTENDS TO REMOVE IMPLANTS AND AND PUT CEMENT SPACER FOR REVISION SURGERY ON (B)(6) 2024. UPDATE: SURGEON ONLY EXPLANTED THE INSERT. AND REPLACED WITH A NEW ONE. INFECTION DOESN'T LOOK LIKE FROM THE IMPLANT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 18652449 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT KNEE I & D POLY SWAP DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 17377348 ↗
• InjuryJun 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. REVISED A TIBIAL INSERT MAINLY TO ACCESS THE POSTERIOR SOFT TISSUE TO REMOVE SCAR TISSUE FOR BETTER RANGE OF MOTION. RIGHT KNEE.

  Patient problems: Loss of Range of Motion; Scar Tissue

  MAUDE report 17180241 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A MANIPULATION UNDER ANESTHESIA ON AN UNKNOWN DATE.

  Patient problems: Loss of Range of Motion

  MAUDE report 16830774 ↗
• InjuryJul 19, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  PATIENT LEFT VOICEMAIL REPORTING A PRIMARY KNEE IMPLANT LESS THAN 2 YEARS AGO USING STRYKER TRIATHLON KNEE AND ALLEGES SWELLING, STIFFNESS & DIFFICULTY WALKING. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL. LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Swelling/ Edema

  MAUDE report 15050950 ↗

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-1261-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 6 11 MM
• Z-1266-2024 · Feb 6, 2024 · Open, Classified
  NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
• Z-1262-2024 · Feb 6, 2024 · Open, Classified
  X3 TRIATHLON CS INSERT NO 7 9 MM
• 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-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