Triathlon 5517-F-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327040906), received between Apr 22, 2022 and Apr 24, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: A LEFT FEMUR WAS IMPLANTED ON A RIGHT TKA ON (B)(6) 2023. THE REGISTRY FLAGGED IT WITH THE HOSPITAL. PATIENT REPORTING SYMPTOMS CONSISTENT WITH INCORRECT SIDE FEMUR.

  Patient problems: Pain

  MAUDE report 24981009 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  LEFT TOTAL KNEE. THE REVISION TODAY WAS SECONDARY TO A PCL TEAR. THE FEMUR AND INSERT WERE REVISED TO A PS CONSTRUCT. THE USE OF MAKO DURING THE INDEX PROCEDURE WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THIS COMPLICATION. NO FURTHER INFORMATION AVAILABLE FROM DOCTOR OR HOSPITAL.

  Patient problems: Damage to Ligament(s)

  MAUDE report 24640815 ↗
• InjuryApr 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO THE FEMORAL COMPONENT CRACKING NEARLY IN HALF (CRACK RUNS ANTERIOR TO POSTERIOR). INTRA-OPERATIVELY, THE FOLLOWING WERE NOTED: THE LATERAL SIDE OF THE IMPLANT SHOWED ALMOST COMPLETE FIBROUS INGROWTH (ALMOST NO BONY INGROWTH). THE DAMAGE TO THE FEMORAL COMPONENT CAUSED MINOR DAMAGE TO THE PATELLAR COMPONENT (NOT ENOUGH TO REVISE THE PATELLAR COMPONENT). THE FEMORAL COMPONENT AND LINER WERE REVISED (NO ALLEGATIONS AGAINST THE REVISED LINER) TO A CEMENTED CR FEMORAL COMPONENT AND CS LINER. REP PROVIDED PICTURES. REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 19142432 ↗
• InjuryApr 2, 2024Degraded; Degraded

  DR. REVISED A LEFT TKA DONE ORIGINALLY MANUALLY ON DUE TO POSTERIOR WEAR OF THE TIBIAL INSERT AND METAL WEAR OF THE BASEPLATE FROM FEMORAL COMPONENT CONTACT. REVISED TO A UNIVERSAL BASEPLATE AND CEMENTED CR FEMUR. NO ALLEGATIONS MADE AGAINST THE IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 19017672 ↗
• InjuryMar 18, 2024Mechanical Problem; Use of Device Problem; Mechanical Problem; Use of Device Problem

  PATIENT REPORTED LEFT KNEE PAIN AND NOTED PRODUCT IS "TOO LARGE". PATIENT IS SCHEDULED FOR A REVISION ON MARCH 21ST. AS PER MEDICAL REVIEW: "THE ADDITIONAL RADIOGRAPHS CONFIRM THAT THE FEMORAL IMPLANT IS AT THE VERY LEAST HYPER FLEXED, OUT OF THE RANGE OF ACCEPTABILITY. IT MAY WELL BE OVERSIZED AS WELL WHICH CAN ONLY BE DETERMINED USING DIGITAL OR ACETATE TEMPLATES. THE TIBIAL IMPLANT IS ALSO HYPER FLEXED WITH SOME POSTERIOR OVERHANG."

  Patient problems: Pain

  MAUDE report 18921744 ↗
• InjuryMar 27, 2023Loss of Osseointegration; Noise, Audible; Loss of Osseointegration; Noise, Audible

  PATIENT REPORTED JOINT LOOSENING AND AUDIBLE NOISE FOLLOWING PRIMARY TRIATHLON LEFT KNEE SURGERY. PATIENT STATED THAT SYMPTOMS STARTED "IMMEDIATELY" FOLLOWING THE (B)(6) 2020 SURGERY AND THAT THE KNEE WAS"NEVER GOOD". PATIENT STATED SHE FEELS THE LOOSENING AND DID NOT STATE WHETHER HER SURGEON CONFIRMED THE LOOSENING. PATIENT STATED THAT THE JOINT NOISE IS HEARD WHEN SHE MOVES HER "TOES UP AND DOWN".

  Patient problems: Inadequate Osseointegration

  MAUDE report 16619641 ↗
• InjuryApr 22, 2022Fracture; Fracture

  PATIENT PRESENTED TO CLINIC WITH PAIN DISCOMFORT AND FX TRIATHLON FEMORAL IMPLANT. ANTERIOR TROCHLEAR PORTION MED TO LATERAL FRACTURE OF METAL FEMUR. REVISION KNEE SURGERY NOT SCHEDULED.

  Patient problems: Pain

  MAUDE report 14186350 ↗