Triathlon 5531-G-309Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 07613327045727), received between Jan 11, 2017 and Oct 31, 2025 — classified as 37 injuries, 3 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE I&D WITH TRIATHLON TIBIAL INSERT EXCHANGE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23442518 ↗
• InjuryAug 20, 2025Unstable; Naturally Worn; Unstable; Naturally Worn

  NO NEW INFORMATION.

  Patient problems: Joint Laxity

  MAUDE report 22850815 ↗
• InjuryJul 20, 2023Naturally Worn; Naturally Worn

  REVISED A LEFT KNEE TIBIAL INSERT DUE TO PATIENT RUPTURING THEIR PCL AND BECOMING UNSTABLE AND POLY WEAR POSTERIORLY AS A RESULT.

  Patient problems: Ambulation or Postural Difficulties; Rupture

  MAUDE report 17368421 ↗
• InjuryDec 16, 2022Unstable; Unstable

  HAD A COMPLETE REVISION OF A STRYKER KNEE IMPLANT WITHIN A 3 MONTH PERIOD OF INITIAL IMPLANT. REVISION INCLUDED STRYKER PRODUCTS AS WELL. ADDITIONAL INFORMATION REPORTED IN ADVERSE CONSEQUENCES: DURING THE 3 MONTHS FOLLOWING THE INITIAL IMPLANT, THE NEED FOR THE REVISION WAS DIAGNOSED BY THE ORTHO SURGEON. THIS WAS DUE TO CONSTANT PAIN THAT EXTENDED FROM MY KNEE TO MY CALF. THIS WAS ACCOMPANIED BY PERSISTENT SWELLING, BUCKLING, LOCKING UP AND LATERAL MOVEMENT. ADDITIONALLY I BROKE MY FOOT DUE TO KNEE INSTABILITY. PATIENT CONFIRMED THIS PI IS FOR THE RIGHT KNEE.

  Patient problems: Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15995375 ↗
• InjurySep 15, 2022Unstable; Naturally Worn; Unstable; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. INTRA-OPERATIVELY WEAR OF THE INSERT WAS NOTED BOTH POSTERIOR-MEDIALLY AND LATERALLY. A 3X9 CS INSERT WAS REVISED TO A 3X19 CS INSERT.

  Patient problems: Joint Laxity

  MAUDE report 15433428 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "IF I WALK FOR A LONG TIME, SOMETIMES PLAYING TENNIS, KNEELING. MILD PAIN BUT TOLERABLE. STILL PLAYING DOUBLES TENNIS AND REMAINS VERY ACTIVE. DID NOT EXPECT TO EXPERIENCE SUCH PAIN. PLEASE WITH OVERALL OUTCOME, JUST SURPRISED OF EXPERIENCING PAIN SO FAR OUT FROM SURGERY. THIS PAIN DOES NOT CAUSE HER TO STOP ACTIVITIES OR REQUIRE ANY MEDICATION INTERVENTION."

  Patient problems: Pain

  MAUDE report 14187055 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FLEXION, TIGHTNESS AND STIFFNESS. THE SURGEON REVISED THE TRIATHLON CR FEMORAL COMPONENT TO A PS, THE PATELLA AND POLY. THE BASEPLATE WAS NOT REVISED.

  Patient problems: Loss of Range of Motion

  MAUDE report 14071308 ↗
• InjuryDec 29, 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 RANGE OF MOTION ISSUES. AFTER ADDRESSING THE PATIENT'S SOFT TISSUE, THE SURGEON EXCHANGED A 3X9 CS INSERT FOR ANOTHER 3X9 CS INSERT. REP PROVIDED REVISION USAGE AND A PICTURE OF THE EXPLANT AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 13115251 ↗
• InjuryOct 4, 2021Material Discolored; Adverse Event Without Identified Device or Use Problem; Material Discolored; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. PRIMARILY, THE SURGEON WAS RESURFACING THE PATIENT'S PATELLA BECAUSE THEY WERE EXPERIENCING PAIN. WHILE IN THERE, THE SURGEON DECIDED TO SWAP THE TRIATHLON X3 CS INSERT DUE TO IT LOOKING OXIDIZED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 12569394 ↗
• InjuryMay 24, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED AFTER COMPLAINT OF INSTABILITY AND DISLOCATION. INITIALLY, SURGEON PLANNED TO DO A POLY EXCHANGE DUE TO POSTERIOR WEAR OF THE POLY. HOWEVER, BECAUSE THE PATIENT CONTINUED TO WALK ON THE KNEE FOR MONTHS, THE POLY WORE THROUGH, THE TIBIAL BASEPLATE BECAME DAMAGED, AND THE FEMORAL COMPONENT BECAUSE SCRATCHED UP. SIGNIFICANT METAL DEBRIS WAS NOTED INTRA-OPERATIVELY. THE FEMORAL COMPONENT, INSERT, AND BASEPLATE WERE REVISED. REP CONFIRMED HE CAN PROVIDE SOME PICTURES, AND THAT OTHERWISE, NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11869232 ↗
• InjuryMar 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. A SIZE 3 TRIATHLON TIBIAL BASEPLATE, 3 X 9 CS INSERT, AND UNKNOWN FEMORAL COMPONENT WERE REVISED. REP CONFIRMED THAT OTHER THAN THE EXPLANT PICTURES AND REVISION USAGE SHEET, NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 11490347 ↗
• MalfunctionJan 26, 2021Difficult to Insert; Difficult to Insert

  THE CUSTOMER REPORTED THAT : "WE HAD A MATERIALOVIGILANCE ON A TIBIAL INSERT. IT COULD NOT BE PUT IN PLACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11232960 ↗
• InjuryDec 10, 2020Naturally Worn; Naturally Worn

  DR. REVISED A PRIMARY LEFT TRIATHLON CEMENTLESS KNEE DUE TO MEDIAL POSTERIOR POLY AND BASEPLATE WEAR. HE NOTED AND OBSERVED HE FELT THE TIBIAL BASEPLATE WAS ORIGINALLY PLACED IN TOO MUCH EXTERNAL ROTATION AND THEREFORE IN FLEXION THE PATIENT EDGE-LOADED THE TIBIAL IMPLANTS.

  Patient problems: No Information

  MAUDE report 10982424 ↗
• InjuryNov 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN. A 3X9 CS INSERT WAS SWAPPED FOR A NEW 3X9 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 10874108 ↗
• InjuryNov 13, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO POSTEROLATERAL WEAR OF THE INSERT. A 3X9 CS INSERT WAS REVISED TO A 3X11 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 10834909 ↗
• InjuryOct 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT DEVELOPED SYMPTOMS OF ACUTE INFECTION AND ASPIRATION OF SYNOVIAL FLUID FROM THE RIGHT KNEE JOINT AND INFLAMMATORY MARKERS WERE INDICATIVE OF DEEP INFECTION. THE PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT AS WELL AS REVISION OF THE POLYETHYLENE TIBIAL INSERT ON (B)(6) 2019.

  Patient problems: Unspecified Infection

  MAUDE report 10725261 ↗
• InjuryOct 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON REPORTED HE IS EXPERIENCING A HIGH COMPLICATION RATE WITH PATIENTS WHOSE PRIMARY PROCEDURES WERE MAKO PROCEDURES. THE NATURE OF THE 10 CASES IS UNKNOWN AT THE TIME OF REPORT. COMPLICATIONS REPORTED INCLUDE EFFUSIONS, PAIN, STIFFNESS, POSSIBLY REQUIRING 'SCOPES' AND/ OR POLY EXCHANGES. THE NATURE OF INTERVENTION FOR EACH OF THE 10 PATIENTS IS UNKNOWN. UPDATE: CLINICIAN REVIEW OF ADDITIONAL INFORMATION RECEIVED INDICATES PATIENT HAD A LEFT KNEE ASPIRATION OF 15ML BLOODY FLUID.

  Patient problems: Aspiration/Inhalation; Pain

  MAUDE report 10680750 ↗
• InjurySep 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED INDICATES PATIENT HAD A LEFT KNEE ARTHROSCOPY, LAVAGE, AND SYNOVIAL CAUTERIZATION ON (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 10601143 ↗
• InjurySep 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED BY THE SALES REP: INSERT SWAP ON PREVIOUSLY PLACED TOTAL KNEE NOT SURE OF ORIGINAL IMPLANT DATE. "WHEN I ASKED SURGEON WHAT HAPPENED HE STATED ¿INSERT POPPED UP¿. I DID NOT SEE THE INSERT IN THE JOINT, ONLY ON BACK TABLE AFTER REMOVED FROM JOINT."

  Patient problems: Insufficient Information

  MAUDE report 10592331 ↗
• InjurySep 25, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A LEFT KNEE ASPIRATION 15ML BLOODY SYNOVIAL FLUID ON (B)(6) 2019 AFTER COMPLAINT OF PAIN, STIFFNESS, AND EFFUSION.

  Patient problems: Pain

  MAUDE report 10585065 ↗
• InjurySep 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A LEFT KNEE ASPIRATION 15ML HEMARTHROSIS ON (B)(6) 2019 AFTER COMPLAINT OF PAIN, STIFFNESS, AND EFFUSION.

  Patient problems: Pain

  MAUDE report 10580789 ↗
• InjuryAug 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A PLANNED REVISION FOR ANTERIOR KNEE PAIN TOOK PLACE, DURING THE CASE, THE SURGEON COMMENTED THAT HE FELT THE ANTERIOR LIP OF THE CS POLY WAS IMPINGING IN THE PATELLA TENDON.

  Patient problems: Injury; Pain

  MAUDE report 10399627 ↗
• InjuryFeb 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAS HAD PERSISTENT PAIN AND SWELLING IN KNEE IN THE ANTERIOR ASPECT OF THE KNEE RIGHT AFTER SURGERY AND IT NEVER WENT AWAY. X RAYS WERE DONE AND THERE WAS POSSIBLE WEAR ON THE UNDERSURFACE OF THE PATELLA. PATIENT WAS UNSURE ABOUT GETTING A REVISION DONE AND WANTED TO CONTINUE WITH CONSERVATIVE MEASURES. KNEE WAS ASPIRATED WITH SHOWED NEGATIVE FOR INFECTION. PATELLA RESURFACING AND LINER EXCHANGE WAS SCHEDULED ON (B)(6) 2019 FOR SURGERY ON (B)(6) 2019.

  Patient problems: Injury; Pain

  MAUDE report 9659086 ↗
• InjuryNov 22, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO FEMORAL OSTEOLYSIS CAUSED BY POLY WEAR. THE PATIENT'S FEMORAL COMPONENT AND 3X9 CS INSERT WERE REVISED TO A TS FEMUR WITH STEM AND AUGMENTS, AND A PS INSERT.

  Patient problems: Injury; Osteolysis

  MAUDE report 9361749 ↗
• InjurySep 24, 2019Mechanical Problem; Mechanical Problem

  REVISION OF TIBIAL BASEPLATE AND POLY DUE TO MOVEMENT IN POLY AND BASEPLATE FROM LOCKING MECHANISM. SEPTEMBER 3, 2019: UPDATE PER SALES REP, "IT WAS NOT AN ALL POLY. PRODUCT CODES WERE (B)(4) AND (B)(4). SPECIFIC LOT NUMBERS ARE UNKNOWN."

  Patient problems: Injury

  MAUDE report 9109211 ↗