Triathlon 5517-F-302Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327040951), received between Mar 1, 2018 and Nov 17, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2025Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. SURGEON ALSO REPORTED THE BASEPLATE APPEARED LOOSE ON CT BUT WAS NOT EASILY REMOVED. A CR/ CS KNEE WAS CONVERTED TO A TS KNEE WITH AUGMENTS AND STEMS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 23575448 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "PATIENT REVISED DUE TO MCL DEFICIENCY. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." A CR KNEE WAS CONVERTED TO A TS KNEE WITH STEMS AND AUGMENTS.

  Patient problems: Damage to Ligament(s)

  MAUDE report 21593121 ↗
• InjuryMar 1, 2024Degraded; Unstable; Device Dislodged or Dislocated; Degraded; Unstable; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO GLOBAL INSTABILITY AND PAIN. INTRA-OPERATIVELY, THE FOLLOWING WERE OBSERVED: THE LOCKING WIRE OF THE INSERT BROKE, AND THE INSERT DISLODGED FROM THE BASEPLATE. THE FEMORAL COMPONENT WAS ARTICULATING POSTERIORLY, CAUSING INSERT WEAR AND METALLOSIS DUE TO ARTICULATING WITH THE BASEPLATE. THE BASEPLATE'S POSTERIOR MEDIAL PORTION WAS BROKEN OFF. PATIENT'S ACTIVITY LEVEL WAS NORMAL, NO TRAUMA REPORTED. THE PATIENT'S CR KNEE (INCLUDING PATELLAR COMPONENT) WAS CONVERTED TO A TS KNEE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 18814726 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO ARTHROFIBROSIS. A FEMORAL COMPONENT AND INSERT WERE REVISED.

  Patient problems: Scar Tissue

  MAUDE report 18272923 ↗
• InjuryOct 16, 2023Malposition of Device; Malposition of Device

  REVISED A RIGHT TRIATHLON TOTAL KNEE ORIGINALLY DONE ON (B)(6) 2022 DUE TO ASEPTIC LOOSENING, POSSIBLE INFECTION. INTRA-OP HE NOTICED WHEN REMOVING THE TIBIAL BASEPLATE, THE POSTERIOR-MEDIAL PEG WAS SHEARED OFF. DR. DIDN'T BELIEVE IT HAPPENED DUE TO HIS TECHNIQUE OF EXTRACTION AS THE BASEPLATE WAS ALREADY LOOSE. HE IS NOT SURE HOW OR WHEN IT COULD HAVE HAPPENED. HE REVISED TO A TRIATHLON TS KNEE. HE DID NOT REVISE THE PATELLA COMPONENT. PER REVIEW OF THE MEDICAL RECORDS BY A CLINICIAN: "REGARDING THE SHEARING OFF OF THE BASE PLATE PEG THIS CAN BE CAUSED BY ABNORMAL FORCES PLACED ON THE IMPLANT. THE FEMORAL COMPONENT WAS IN CONSIDERABLE VARUS IN THE TIBIAL COMPONENT HAD SUBSIDED LATERALLY. UPON WEIGHT BEARING THIS COULD CONTRIBUTE TO BREAKAGE OF THE PEG."

  Patient problems: Inadequate Osseointegration; Unspecified Infection

  MAUDE report 17939047 ↗
• InjuryAug 24, 2023Degraded; Fracture; Adverse Event Without Identified Device or Use Problem; Degraded; Fracture; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD INITIAL KNEE REPLACEMENT APPROXIMATELY 8 YEARS AGO. TRIATHLON TRITANIUM. PATIENT CAME TO SEE DR. IN CLINIC WITH KNEE PAIN. X RAYS WERE TAKEN AND REVEALED THAT THE TIBIAL BASEPLATE WAS BROKEN AS WELL AS THE LATERAL POSTERIOR PROXIMAL FEMUR. REVISION SURGERY WAS 7/31. ONCE THE KNEE WAS OPENED, WE NOTICED THE LOCKING WIRE ON POLY WAS BROKEN AS WELL. METAL WAS FLOATING AROUND THE JOINT AND ENDED UP UNDERNEATH THE POLY WHERE IT WAS WORK INTO THE BACKSIDE OF THE PLASTIC. ALL IMPLANTS WERE REMOVED AND REVISED WITH TRIATHLON TS. PER MEDICAL REVIEW: "THERE IS A FRACTURE OF THE INFERIOR POLE OF THE PATELLA PRESENT" WHICH REPORTEDLY "FULLY HEALED" WITHOUT MEDICAL INTERVENTION.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 17609799 ↗
• InjuryJun 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING OCCURRED DURING A RIGHT MAKO KNEE: AFTER IMPLANTATION OF A CR PRESS-FIT KNEE, WHILE THE PATIENT WAS STILL OPEN, SURGEON WANTED TO LOOK IN THE JOINT AND REMOVED THE IMPLANTED INSERT (REASONS FOR WANTING TO INSPECT THE JOINT WERE NOT REPORTED) AND THE TOURNIQUET WAS LIFTED. EXCESSIVE BLEEDING WAS NOTED IN THE PATIENT, THE VASCULAR TEAM WAS CALLED IN AND THE REP LEFT THE OPERATING ROOM. MEASURES TAKEN TO ADDRESS THE BLEEDING WERE NOT REPORTED TO THE REP BEYOND THE FACT THAT THE FEMORAL COMPONENT WAS REMOVED. ONCE ADDRESSED, THE ORIGINAL FEMORAL COMPONENT WAS RE-IMPLANTED AND A NEW INSERT WAS RE-IMPLANTED. SURGEON STATED THAT THE MEDIAL SIDE OF THE KNEE FELT UNSTABLE AND DECIDED TO CONVERT THE KNEE TO A PS KNEE (NO DETAILS WHY KNEE WAS UNSTABLE WERE REPORTED BY THE SURGEON). TO ACCOMMODATE THE NEW INSERT, THE ORIGINAL TIBIAL BASEPLATE WAS REMOVED AND A UNIVERSAL BASEPLATE WAS IMPLANTED ALONG WITH THE NEW FEMORAL COMPONENT AND INSERT REQUIRED FOR THE CONVERSION. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY 90 MINUTES. REP CONFIRMED THAT NO ALLEGATIONS WERE MADE AGAINST THE CUTS MADE BY THE ROBOT.

  Patient problems: Insufficient Information

  MAUDE report 17160406 ↗
• InjuryJun 5, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "THE REVISION WAS DUE TO PAIN FROM A LOOSE FEMUR. IT WAS SUSPECTED FROM X-RAY THAT THE FEMUR WAS LOOSE. IT WAS DISCOVERED DURING SURGERY THAT THE FEMUR DID NOT IN-GROW AND WAS IN FACT LOOSE. THE USE OF MAKO IN THE PRIMARY KNEE WAS NOT THOUGHT TO HAVE ANYTHING TO DO WITH THE LOOSE FEMUR. THERE WAS NO EVIDENT REASON FOR THE LOOSE FEMUR. NO FURTHER INFORMATION IS AVAILABLE FROM THE HOSPITAL OR SURGEON." A FEMORAL COMPONENT AND INSERT WERE REVISED TO A FEMORAL COMPONENT WITH STEM AND AUGMENTS AND A NEW INSERT.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17059685 ↗
• InjuryApr 24, 2023Malposition of Device; Malposition of Device

  KNEE REVISION. REASON FOR REVISION: INSTABILITY. UPDATE: IN THIS PARTICULAR CASE THE FEMORAL COMPONENT WAS PLACED POSTERIOR TO ITS IDEAL POSITION AND THE TIBIAL IMPLANT WAS PLACED IN A GREATER DEGREE OF FLEXION THAN IDEAL.

  Patient problems: Joint Laxity

  MAUDE report 16793260 ↗
• InjuryDec 2, 2022Unintended Movement; Insufficient Device Problem Information; Unintended Movement; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUBSIDENCE OF THE TIBIAL BASEPLATE AND PCL ISSUES. FEMORAL COMPONENT, INSERT, AND BASEPLATE WERE REVISED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15904371 ↗
• InjuryNov 29, 2021Unstable; Unstable

  AS REPORTED: "REVISION SURGERY DONE ON A RIGHT TOTAL KNEE. THE REVISION WAS DONE FOR INSTABILITY. NO OTHER INFORMATION IS AVAILABLE." A CR FEMORAL COMPONENT AND CS INSERT WERE EXPLANTED AND REPLACED WITH A PS FEMORAL COMPONENT WITH TS INSERT, FEMORAL AUGMENT, AND FEMORAL FIXATION PEG. SPOKE TO REP: REP CONFIRMED THAT THERE ARE NO ALLEGATIONS OF ISSUES ARISING FROM BONE CUTS MADE IN THE PRIMARY MAKO PROCEDURE. REP ALSO CONFIRMED THERE WERE NO ADDITIONAL INTRA-OPERATIVE OBSERVATIONS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 12888024 ↗
• InjuryMar 18, 2020Loss of Osseointegration; Loss of Osseointegration

  DR. REVISED A TRIATHLON PA BEADED FEMORAL COMPONENT SIZE 3 TO A CEMENTED SIZE 2 PRIMARY CR FEMUR. HE ALSO SWAPPED THE TIBIAL INSERT. HE DID THIS DUE TO PATIENT STIFFNESS. HE SAID THE IMPLANT WASN'T GROSSLY LOOSE, BUT NOTED THE DISTAL AND POSTERIOR INTERFACE WAS MOSTLY FIBROUS INGROWTH. HE DID NOTE THE ORIGINAL X-RAY, IT LOOKED LIKE THE FEMUR MAY HAVE BEEN FLEXED SLIGHTLY RELATIVE TO THE CUTS WHICH CAUSED A SLIGHT GAP IN CERTAIN AREAS. RIGHT KNEE. UPDATE 20/FEBRUARY/2020 WG: REP PROVIDED PRIMARY AND REVISION USAGE SHEETS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9849333 ↗
• InjuryAug 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IN REPORTING A REVISION OF PATIENT'S RIGHT FEMUR ON (B)(6) 2018, REP REPORTED THAT A PLATE HAD BEEN PLACED (B)(6) 2017 TO ADDRESS A DISTAL FEMORAL PERIPROSTHETIC FRACTURE SUSTAINED AFTER PATIENT FELL. THE PATIENT HAD A STRYKER KNEE CONSTRUCT IMPLANTED IN (B)(6) OF 2016 AT THE TIME. NO COMPONENTS WERE EXPLANTED, A STRYKER PLATE AND 15 SCREWS WERE IMPLANTED.

  Patient problems: Bone Fracture(s); Fall; Injury

  MAUDE report 7772945 ↗
• InjuryJun 7, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  PRIMARY RIGHT TKA. IT WAS REPORTED THAT UPON OPENING THE IMPLANT, SOME WHITISH FOREIGN MATERIAL WAS OBSERVED TO BE ADHERED TO THE WAIST OF THE IMPLANT. REP WAS PRESENT FOR THE PROCEDURE AND PERSONALLY WITNESSED THE FOREIGN MATTER. REP HAS ALSO RETAINED ALL PACKAGING AND PROVIDED PICTURES OF THE IMPLANT AND OUTER BOX. THE DEVICE IS AVAILABLE FOR RETURN HAVING NOT BEEN CLEANED IN ANY WAY. NO SURGICAL DELAY WAS CAUSED AS ANOTHER IMPLANT WAS OPENED AND MADE READY WHILE THE SURGEON WAS MAKING HIS CUTS. THE IMPLANT STICKER DID NOT GET PLACED ON THE IMPLANT SHEET.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7577865 ↗
• InjuryMar 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD TK ON (B)(6) 2017. COULD NOT GET FULL EXTENSION. A REVISION OF FEMORAL COMPONENT WAS PERFORMED.

  Patient problems: Injury; Loss of Range of Motion; Scar Tissue

  MAUDE report 7306481 ↗