Triathlon 5532-P-311Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327042665), received between Jul 11, 2017 and Jul 6, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 6, 2026Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED: AT 4:00 PM, DURING A BILATERAL TKA PROCEDURE, AN ISSUE OCCURRED WHILE INSERTING THE FINAL POLYETHYLENE INSERT. AFTER THE FINAL FEMORAL AND TIBIAL COMPONENTS HAD BEEN IMPLANTED, THERE WERE NO PROBLEMS DURING UNPACKING OF THE INSERT. HOWEVER, WHEN ATTEMPTING TO INSERT THE FINAL INSERT, THE LOCKING WIRE DETACHED IMMEDIATELY. THEN, WE DECIDED TO OPEN THE NEW INSERT FOR SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25725120 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: IT WAS REPORTED, BY A FAMILY MEMBER OF A PATIENT, THAT A PATIENT WHICH HAD KNEE IMPLANT IMPLANTED IN (B)(6) 2021 EXPERIENCED CONTINUOUS PAIN, ACCOMPANIED BY SEVERE INFLAMMATION, EXTREME SWELLING (TWICE THE NORMAL SIZE), HEAT IN THE AREA AND REDUCED MOBILITY AFTER SURGERY. SINCE THEN, THE PATIENT HAS BEEN UNABLE TO LEAVE THE WALKER. BEFORE SURGERY, DURING THE WAIT TIME OF FOR THE SURGERY, WALKERS AND CRUTCHES WERE USED TO WALK. IT WAS REPORTED THAT A DOCTOR REFERRED THE PATIENT TO SEVERAL SPECIALISTS AND TESTS BUT FOUND NO CLEAR CAUSE FOR THE CONDITION. IN (B)(6) 2024, THE PAIN IN THE OTHER KNEE BECAME SEVERE, AND SHE WAS GIVEN FENTANYL TO CONTROL IT. FROM THAT MOMENT ON, IT WAS NOTICED RELIEF IN THE OPERATED KNEE. ON (B)(6) 2025 THE PATIENT UNDERWENT A SECOND KNEE SURGERY (THE OTHER KNEE) WITH A PROSTHESIS FROM ANOTHER COMPANY. A DIFFERENCE WAS NOTED BETWEEN THE FIRST AND THIS NEW OPERATION, WHICH HAS EVOLVED WITHOUT THE PROBLEMS EXPERIENCED ON THE FIRST INTERVENTION. CURRENTLY, THE PATIENT IS STILL TAKING FENTANYL.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 21503577 ↗
• InjuryJun 1, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "THE REVISION TODAY WAS SECONDARY TO INSTABILITY. NO FURTHER INFORMATION AVAILABLE FROM HOSPITAL OR SURGEON." SPOKE TO REP. REP CONFIRMED THAT INTRA-OPERATIVELY, NOTHING WAS NOTED TO BE LOOSE, WORN, OR BROKEN. A 3X11 PS INSERT WAS REVISED TO A 3X16 TS INSERT.

  Patient problems: Joint Laxity

  MAUDE report 17037534 ↗
• InjuryMar 16, 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 INFECTION. ALL IMPLANTS WERE REMOVED AND AN ARTICULATING SPACER WAS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 16552980 ↗
• InjuryOct 6, 2022Adverse 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 INFECTION. A 3X11 PS INSERT WAS EXCHANGED FOR ANOTHER 3X11 PS INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 15555841 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT: "ON (B)(6) 2020 PATIENT REPORTED EXCESSIVE KNEE PAIN, MORE SPECIFICALLY ANTERIOR LEFT THIGH START-UP PAIN. RADIOGRAPHS OBTAINED ON (B)(6) 2020 SHOW THE PROXIMAL TIP OF HER FEMORAL STEM HAS ASSOCIATED BONE REMODELING OF THE SURROUNDING CORTEX, ESPECIALLY ANTERIORLY. THE PATIENT IS SCHEDULED TO GET A BONE SCAN TO ASSESS COMPONENT AND WORKUP TO DETERMINE IF THE FEMORAL COMPONENT IS LOOSE.".

  Patient problems: Pain

  MAUDE report 10832091 ↗
• InjuryAug 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED BY THE ATTORNEY, THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2012 WHERE SHAPEMATCH CUTTING GUIDES WERE USED AND A TRIATHLON KNEE SYSTEM WAS IMPLANTED. IT IS UNKNOWN IF THE PATIENT HAS UNDERGONE REVISION SURGERY AT THIS TIME. UPDATE VIA CONVERSATION WITH LEGAL DEPARTMENT JULY 30, 2019: THE PATIENT HAS COMPLAINED OF PAIN BUT DOES NOT WANT TO PURSUE SURGICAL INTERVENTION AT THIS TIME.

  Patient problems: Pain

  MAUDE report 8890766 ↗
• MalfunctionJul 11, 2017Packaging Problem; Packaging Problem

  DAMAGED STERILE BARRIER WAS FOUND WHEN THE NURSE OPENED THE OUTER BOX TO USE THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6703143 ↗