Triathlon 5510-F-301Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327040258), received between Jan 10, 2017 and Nov 4, 2025 — classified as 17 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unstable” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2025Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT MAKO KNEE WAS REVISED DUE TO INSTABILITY (SURGEON REPORTED IMPLANTS WERE WELL FIXED AND POSITIONED, THE INSTABILITY WAS RELATED TO THE PATIENT'S SOFT TISSUES). A CR FEMUR AND CS INSERT WERE REVISED TO A PS FEMUR AND INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 23472320 ↗
• InjuryApr 25, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 21914230 ↗
• InjuryOct 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE SALES REP THAT SURGEON NOTIFIED ABOUT THE TKR REVISION IS NEEDED. UPDATE: REASON FOR REVISION DUE TO DISLOCATION.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 15622030 ↗
• InjuryOct 27, 2021Unstable; Unstable

  AS REPORTED: "REVISION WAS PERFORMED FOR INSTABILITY OF THE JOINT IN EXTENSION. NO OTHER INFORMATION AVAILABLE FROM THE HOSPITAL." LEFT KNEE. PATIENT WAS REVISED FROM A CS TIBIAL INSERT AND CR FEMORAL COMPONENT TO A PS TIBIAL INSERT AND A TS FEMORAL COMPONENT WITH AUGMENTS AND A STEM.

  Patient problems: Insufficient Information

  MAUDE report 12704311 ↗
• InjurySep 20, 2021Unstable; Unstable

  THIS PR WAS RAISED FROM A MEDICAL REVIEW FOR ANOTHER EVENT. THE PATIENT HAD LEFT KNEE ARTHROPLASTY ON (B)(6) 2011. A QUAD REPAIR WAS CARRIED OUT SIX MONTHS POST IMPLANTATION. REVISION SURGERY TOOK PLACE ON (B)(6) 2012 DUE TO INSTABILITY WHEREBY THE INSERT WAS REVISED. REVISION SURGERY TOOK PLACE ON (B)(6) 2016 DUE TO SUBSIDENCE AND INSTABILITY WHEREBY ALL COMPONENTS WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12496869 ↗
• InjurySep 14, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO STIFFNESS. A FEMORAL COMPONENT AND INSERT WERE REVISED, AND RELEASES WERE PERFORMED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Muscular Rigidity

  MAUDE report 12467304 ↗
• InjuryFeb 2, 2021Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY AND PAIN. A CR FEMUR AND INSERT WERE REVISED TO A TS FEMUR, PS INSERT, CEMENTED STEM AND AUGMENTS. REP PROVIDED PRIMARY AND REVISION USAGE AND A PICTURE OF THE EXPLANTED LINER, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11264629 ↗
• InjuryNov 6, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THROUGH A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2018 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY WITH SIMPLEX HV BONE CEMENT WITH GENTAMICIN. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT REVISION SURGERY DUE TO ALLEGED LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10801814 ↗
• InjurySep 1, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENT. SURGEON REPORTED THAT THE DISTAL FEMUR METAPHYSIS LOOKED "DISINTEGRATED." PATIENT'S KNEE CONSTRUCT WAS REVISED TO A HINGED DISTAL FEMUR CONSTRUCT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED TIBIAL BASEPLATE OR INSERT. REP PROVIDED PRIMARY AND REVISION USAGE SHEETS, PRE- AND POST-REVISION X-RAYS, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 10475775 ↗
• InjurySep 5, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO A FAILED UNSTABLE LEFT KNEE REPLACEMENT.

  Patient problems: Injury

  MAUDE report 8964780 ↗
• InjuryJul 26, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "PAIN, GROSS INSTABILITY, MECHANICAL COMPLICATION AND SIGNIFICANT POLYETHYLENE WEAR AND DAMAGE OF LEFT TOTAL KNEE."

  Patient problems: Injury; Pain

  MAUDE report 8830563 ↗
• InjuryJun 19, 2019Unstable; Malposition of Device; Unstable; Malposition of Device

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO MALALIGNMENT AND INSTABILITY".

  Patient problems: Injury

  MAUDE report 8712738 ↗
• InjuryApr 4, 2019Unstable; Osseointegration Problem; Insufficient Device Problem Information; Unstable; Osseointegration Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "LEFT TOTAL KNEE ARTHROPLASTY INSTABILITY PLUS LOOSE."

  Patient problems: Inadequate Osseointegration; Injury; Joint Laxity

  MAUDE report 8482411 ↗
• InjuryFeb 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT KNEE WAS REVISED. A SIZE 3 LEFT CR FEMUR AND 3X9 ALL POLY CS TIBIA WAS REVISED TO A TRIATHLON TS KNEE CONSTRUCT INCLUDING 2 STEMS AND 6 AUGMENTS.

  Patient problems: Injury

  MAUDE report 8360171 ↗
• InjuryJan 7, 2019Unstable; Unstable

  EVENT: SURGEON DETERMINED KNEE WAS UNSTABLE. HE REMOVED FEMORAL COMPONENT AND INSERT. HE IMPLANTED TS FEMORAL COMPONENT WITH THICKER INSERT. PATIENT STABLE. NO COMPLICATIONS.

  Patient problems: Injury

  MAUDE report 8222259 ↗
• MalfunctionNov 27, 2018Use of Device Problem; Use of Device Problem

  INCORRECT SIZE 3 CR LEFT FEMUR IMPLANTED ONTO A RIGHT SIDED FEMUR. IMPLANT CHECKED BY MYSELF, NURSE AND SURGEON PRIOR TO OPENING. KNEE TRACKED WELL AFTER IMPLANTATION AND NOT NOTICED UNTIL TODAYS X-RAY MEETING. UPDATE 06 NOV 2018; WAS THE INCORRECT SIZED DEVICE SELECTED IN ERROR OR DID THE DEVICE SIZE DIFFER TO THE PACKAGING? THE INCORRECT SIDED DEVICE WAS CHOSEN IN ERROR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8108781 ↗
• InjuryJul 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT PRIMARY TKA (B)(6) 2012. PATIENT RETURNED COMPLAINING OF PAIN AND INSTABILITY TO WALK. UNDERWENT REVISION SECONDARY TO INSTABILITY AND FRACTURE OF THE POLYETHYLENE COMPONENT FROM A CS TO A PS. FEMUR AND POLY EXCHANGED.

  Patient problems: Ambulation or Postural Difficulties; Injury; Pain

  MAUDE report 7674717 ↗
• InjuryMay 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED AFTER FALLING AND SUSTAINING A PERIPROSTHETIC FRACTURE OF THE FEMORAL CONDYLE (REP REPORTED PATIENT HAS LIMITED MOBILITY DUE TO HAVING MS AND HAD ANOTHER POST-OP FALL PREVIOUSLY).

  Patient problems: Bone Fracture(s); Injury; Limited Mobility Of The Implanted Joint

  MAUDE report 7493536 ↗
• MalfunctionJan 10, 2017Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Device Packaging Compromised; Packaging Problem; Device Damaged Prior to Use; Packaging Problem

  THE NURSE IN THE ROOM OPENED THE OUTSIDE BOX TO OPEN THE IMPLANT AND THE INSIDE PACKAGE WAS DAMAGED (CRACKED).

  Patient problems: No Patient Involvement

  MAUDE report 6239321 ↗