Triathlon 5517-F-501Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327040982), received between Nov 22, 2017 and Jan 29, 2024 — classified as 14 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unstable” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2024Osseointegration Problem; Osseointegration Problem

  AS REPORTED VIA MEDWATCH MW5149272 AND MW5149273 (REPORTS ARE THE SAME WITH A DIFFERENT IMPLANT FOR EACH REPORT): I HAD TOTAL KNEE IMPLANT ON MY LEFT LEG. I HAVE BEEN HAVING PROBLEM WITH IT SINCE DAY ONE. NOW THE BONE SCAN INDICATES THAT THE IMPLANT IS SHOWING THAT IT IS LOOSE AND MY DOCTOR IS RECOMMENDING REPLACE THE TOTAL KNEE IMPLANT. MY IMPLANT CATALOG NUMBER IS THE SAME AS IN THIS RECALL LETTER; CLASS 2 DEVICE RECALL TRIATHLON TRITANIUM TIBIAL COMPONENT, SEE RELATED INFORMATION DATE INITIATED BY FIRM MARCH 30, 2022. DATE POSTED JUNE 3, 2022, RECALL STATUS1 OPEN3, CLASSIFIED RECALL NUMBER Z-1237-2022; RECALL EVENT ID 90241 510(K) NUMBER K123486...I HAVE MY OPERATIVE REPORTS FROM THE HOSPITAL, AND MY DOCTOR WAS INDICATE THAT THIS IMPLANT WAS INSTALLED. I HAVE BEEN SCHEDULED FOR A REVISION SURGERY FOR 2023. NOTE: CATALOG NUMBERS PROVIDED IN THE RECALL NOTICE WERE NOT REPORTED IN EITHER MEDWATCH REPORT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18603253 ↗
• InjuryJan 2, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  REVISED A LEFT CEMENTLESS TRIATHLON. HE REVISED THE FEMUR FROM A SZ 5 TO A 4 TS W STEM AND FROM A 5X9 CS TO A 5X9 PS. THIS WAS DUE TO LIMITED RANGE OF MOTION FOR THE PATIENT.

  Patient problems: Loss of Range of Motion

  MAUDE report 18429023 ↗
• InjuryOct 20, 2023Use of Device Problem; Use of Device Problem

  A PRIMARY LEFT TKA WAS PERFORMED. I PRESENTED DR. WITH IMPLANTS ONCE BONE PREPARATIONS WERE MADE AND APPROPRIATELY SIZED FOR A PS KNEE. IMPLANTS WERE PRESENTED, READ OUT LOUD AND VERIFIED BY SIZE, TYPE AND EXPIRATION. IMPLANTS WERE IMPLANTED, PATIENT WAS TRANSFERRED TO RECOVERY. AFTER THE TKA WAS FINISHED AND PATIENT IN RECOVERY, IT WAS BROUGHT TO MY ATTENTION BY MY USAGE THAT THE INCORRECT FEMORAL COMPONENT WAS OPENED AND IMPLANTED. DR. WAS INFORMED. PLANS WERE ARRANGED FOR THE PATIENT TO RETURN TO SURGERY AT 4:30 THE SAME DAY FOR A LEFT REVISION TKA OF THE FEMORAL COMPONENT AND TIBIAL INSERT.

  Patient problems: Insufficient Information

  MAUDE report 17972183 ↗
• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: PERFORMED AN I&D POLY AND FEMUR EXCHANGE ON A LEFT KNEE. THIS WAS DUE TO INFECTION. NO ALLEGATIONS AGAINST THE IMPLANTS MADE.

  Patient problems: Unspecified Infection

  MAUDE report 15299465 ↗
• InjuryApr 27, 2021Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. A SIZE 5 TRITANIUM TIBIAL COMPONENT, SIZE 5CR FEMORAL COMPONENT, AND INSERT WERE REVISED TO A SIZE 5 UNIVERSAL BASEPLATE, SIZE 5PS FEMORAL COMPONENT, AND INSERT. SURGEON'S OPINION WAS THAT THE TIBIAL COMPONENT WAS IMPLANTED WITH TOO MUCH VARUS. THERE ARE NO ALLEGATIONS AGAINST THE INSERT. FEMORAL COMPONENT WAS REVISED TO INCREASE KNEE ROTATION, BUT OTHERWISE THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL COMPONENT.

  Patient problems: Pain

  MAUDE report 11730572 ↗
• InjuryMar 23, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. THE PATIENT'S ENTIRE CR KNEE WAS REVISED TO A TS KNEE. REP PROVIDED PRIMARY USAGE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 11555003 ↗
• InjuryOct 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. A SIZE 5 TIBIAL COMPONENT, 5X11 CS INSERT, AND SIZE 5 CR FEMORAL COMPONENT WERE REVISED TO A SIZE 4 PS FEMORAL COMPONENT, 4X16 PS INSERT, SIZE 4 UNIVERSAL BASEPLATE, AND 12X50 STEM. REPORTING REP WAS NOT PRESENT FOR THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 10697507 ↗
• InjuryJul 9, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT: "PATIENT HAD A PAINFUL KNEE, FEMUR WAS LOOSE AND REPLACED." A 5X9 POLY AND #5 PRESS-FIT FEMUR WERE SWAPPED.

  Patient problems: Injury; Pain

  MAUDE report 10251985 ↗
• MalfunctionFeb 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING A MAKO TKR THE FINAL IMPLANT DID NOT FIT WELL. RESULTING IN A CEMENTED FEMUR BEING USED. CEMENTED FEMUR: LOT C7X9Y. DURING THE CASE ALL CUTS WERE CHECKED WITH THE PLANAR PROBE WITH GOOD RESULTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9763296 ↗
• InjuryFeb 10, 2020Unstable; Unstable

  KNEE REVISION DUE TO INSTABILITY.

  Patient problems: Injury

  MAUDE report 9688888 ↗
• InjuryOct 3, 2019Unstable; Malposition of Device; Unintended Movement; Unstable; Malposition of Device; Unintended Movement

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LEFT KNEE, FAILED TOTAL KNEE ARTHROPLASTY." UPDATE TO EVENT DESCRIPTION BASED ON CLINICIAN REVIEW OF THE MEDICAL RECORDS PROVIDED: REGARDING CAUSE OF FAILURE OF THE LEFT KNEE REQUIRING REVISION SURGERY IN (B)(6) 2017, SOME 3-YEARS POST PRIMARY, THERE IS LIMITED INFORMATION. PRIMARY ARTHROPLASTY HAD NO COMPLICATIONS ALTHOUGH AT 3-YEARS FOLLOW-UP THE KNEE WAS DOCUMENTED AS CHRONIC UNSTABLE WITH MID-FLEXION INSTABILITY. THE INSTABILITY WAS CONFIRMED DURING REVISION WHILE ADDITIONALLY THE SURGEON OBSERVED THAT ONLY SOME 20% OF THE TIBIAL BONE INGROWTH SURFACE SHOWED SIGNS OF BONE INGROWTH. ALL COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR DEVICES INCLUDING THE PREVIOUSLY UNRESURFACED PATELLA.

  Patient problems: Injury

  MAUDE report 9151364 ↗
• InjurySep 23, 2019Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A SIZE 5 CR FEMORAL COMPONENT AND 5X11 CS INSERT WERE REVISED TO STRYKER PS DEVICES. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9105199 ↗
• InjuryMay 21, 2019Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED LEFT TOTAL KNEE ARTHROPLASTY DUE TO FAILURE OF INGROWTH OF PRESS FIT COMPONENT".

  Patient problems: Injury

  MAUDE report 8629719 ↗
• InjuryJan 18, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT HAD A PRIMARY TOTAL KNEE WITH A PRESSFIT FEMUR AND A CEMENTED TIBIA DONE APPROXIMATELY 8 YEARS AGO. HE DID FINE UNTIL RECENTLY. HE DEVELOPED LATERAL PAIN. CAT SCAN SHOWED SOME LUCENCY. HE WAS SCHEDULED FOR A REVISION OF THE FEMUR. THE FEMORAL COMPONENT WAS REMOVED WITH THIN OSTEOTOMES. THERE WAS SIGNIFICANT "BONEY" INGROWTH WITH ONE AREA ON THE LATERAL SIDE WITH FIBROUS GROWTH. THE TIBIA AND PATELLAR WERE SOLID AND LEFT INTACT. THE FEMUR WAS CONVERTED TO A CEMENTED PS. THE PATELLAR TRACKED WELL AND THE KNEE WAS WELL BALANCED. THE OPERATION WAS COMPLETED SUCCESSFULLY.

  Patient problems: Injury; Pain

  MAUDE report 8261367 ↗
• InjuryNov 7, 2018Unstable; Unstable

  INSTABILITY, POSTERIOR SAGGING AND WEAR OF PROSTHESIS APPROX. 5 YEARS AFTER IMPLANTATION.

  Patient problems: Injury

  MAUDE report 8046220 ↗
• MalfunctionNov 22, 2017Packaging Problem; Packaging Problem

  A DISTRIBUTOR REPORTED THAT: "BEFORE THE SURGERY, WHEN PREPARING THE DEVICES, THE MEDICAL STAFF OBSERVED THAT THE PACKAGING WAS NOT DAMAGED BUT THE INNER PLASTIC SHELL IS BROKEN AT THE WELD. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7054257 ↗