Triathlon 5510-F-602Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327040326), received between May 29, 2018 and Dec 21, 2022 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Packaging Problem” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2022Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SWELLING, CLANKING, AND JOINT LAXITY. A CR CEMENTED FEMUR AND CS INSERT WERE REVISED TO PS IMPLANTS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity; Swelling/ Edema

  MAUDE report 16021895 ↗
• InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ACTIVE INFECTION WAS NOTED AT TIME OF FAILURE. IMPLANTS WERE REMOVED AND AN ANTIBIOTIC DEVICE WAS PLACED. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15333294 ↗
• InjuryAug 22, 2022Use of Device Problem; Use of Device Problem

  PRIMARY PROCEDURE, LEFT KNEE. IT WAS REPORTED THAT A RIGHT-SIDED FEMORAL COMPONENT WAS IMPLANTED IN THE PATIENT'S LEFT KNEE. THE IMPLANT WAS SHOWN TO O.R. STAFF BY THE REP, WHO THEN GAVE THE IMPLANT TO A NURSE, WHO GAVE IT TO THE SURGICAL TECH, WHO GAVE IT TO THE SURGEON. DISCOVERY WAS MADE AFTER THE PATIENT WAS CLOSED AND THE SURGEON WAS NOTIFIED. SURGEON NOTIFIED THE PATIENT'S FAMILY, WHO DECLINED A REVISION OF THE KNEE. SURGEON'S PLAN IS TO OBSERVE AND ASSESS. REP PROVIDED THE USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 15265418 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT, HE HAD A RIGHT TKA DONE ON (B)(6) 2020. PATIENT HAS BEEN EXPERIENCING PAIN SINCE HIS SURGERY. HE HAS PROBLEMS URINATING, UNABLE TO LAY DOWN AND HAS TO SLEEP ON A RECLINER AND HE'S EXPERIENCING POPPING. HIS PAIN HAS NEVER STOPPED.

  Patient problems: Pain; Urinary Retention

  MAUDE report 14266007 ↗
• InjuryApr 25, 2022Unstable; Unstable

  FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "SWOLLEN KNEE. UNSTABLE WHEN GETTING UP. DIFFICULTY WITH PUTTING ON SOCKS, TYING SHOES LACES; AND GETTING OUT OF DEEP CHAIRS."

  Patient problems: Ambulation or Postural Difficulties; Swelling/ Edema

  MAUDE report 14192810 ↗
• InjuryMay 21, 2019Unstable; Malposition of Device; Unstable; Malposition of Device

  PATIENT CALLED STATING HE HAD A RIGHT KNEE REPLACEMENT DONE ON (B)(6) 2018 AND WAS REVISED ON (B)(6) 2019 DUE TO INSTABILITY. PATIENT STATED HIS SURGERY WAS DONE ROBOTICALLY, AND WOULD LIKE TO KNOW IF THE ROBOT WAS INVOLVED IN A RECALL. UPDATE (B)(6) 2019: AS PER REVISION OPT REPORT "THE DIAGNOSING AT THIS POINT FOR CONTINUED PAIN WAS MALPOSITIONING OF THE FEMUR RESULTING IN INSTABILITY."

  Patient problems: Injury

  MAUDE report 8629177 ↗
• MalfunctionMar 22, 2019Packaging Problem; Packaging Problem

  NURSE OPENED BOX OF FEMUR WHICH WAS IN PERFECT CONDITION. THEN WENT TO OPEN OUTER PLASTIC TO GIVE TO SCRUB NURSE BUT THERE WAS A CRACK IN PLASTIC. WE TRIED TO GET HER TO PEEL FEMUR OUT OF INNER CASING BUT IT WAS TOO HARD AND BECAME UNSTERILE. UPDATE: FEMUR WAS NOT IMPLANTED, 1 MINUTE TO RETRIEVE NEW FEMUR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8444687 ↗
• MalfunctionMar 22, 2019Packaging Problem; Packaging Problem

  AS REPORTED: "THE FEMUR WOULD NOT EXIT FROM THE OUTER PACKAGING. THE INNER PACKAGING WAS STUCK AGAINST THE BROKEN PIECE OF THE OUTER PACKAGING. THE FEMUR COULD NOT PROPERLY LEAVE THE PACKAGING WITHOUT QUESTIONING THE STERILITY OF THE PRODUCT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8444589 ↗
• MalfunctionNov 6, 2018Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS COMPROMISED ON A SIZE 6 RIGHT CR CEMENTED FEMUR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8043151 ↗
• MalfunctionMay 29, 2018Difficult to Open or Remove Packaging Material; Packaging Problem; Difficult to Open or Remove Packaging Material; Packaging Problem

  PRIMARY PROCEDURE, RIGHT KNEE. REP WAS PRESENT FOR THE PROCEDURE AND PERSONALLY WITNESSED THE EVENT. IT WAS REPORTED THAT ON OPENING THE OUTER STERILE BLISTER FOR THE DEVICE, PART OF THE PLASTIC LIP BROKE OFF OF THE PLASTIC TRAY AND CAME UP WITH THE TYVEK. AFTER OPENING THE INNER BLISTER, THE DEVICE WAS TOO TIGHTLY NESTED IN THE PACKAGING TO REMOVE EASILY. THE DEVICE WAS ULTIMATELY NOT USED AS THE TECH'S GLOVE CAME IN CONTACT WITH THE REP'S HAND WHEN BOTH WERE TRYING TO REMOVE THE DEVICE TOGETHER AND THERE WERE CONCERNS ABOUT THE STERILITY OF THE DEVICE. ANOTHER DEVICE WAS OBTAINED AND USED WITHOUT EVENT. THERE WAS NO SURGICAL DELAY AS A DIFFERENT PART OF THE PROCEDURE WAS BEING PERFORMED DURING THE EVENT. THE OUTER BOX WAS DISPOSED OF BEFORE THE REP. COULD TAKE ANY PICTURES OF IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7548411 ↗