Triathlon 5532-G-613Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327050868), received between Dec 27, 2017 and Oct 29, 2022 — classified as 8 injuries, 1 malfunction.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO THE POST OF THE PS INSERT SHEARING OFF. NO TRAUMA WAS REPORTED TO THE REP. A 6X13 PS INSERT WAS REVISED TO A 6X19 TS INSERT. REP REPORTED THAT SOME ADDITIONAL INFORMATION CAN BE PROVIDED (CERTAIN PATIENT DETAILS, DEVICE DETAILS) AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE: "REVISION OF LEFT TKA THAT WAS ORIGINALLY IMPLANTED IN 2011".

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15696870 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT REVISION REQUIRED TO CHANGE OF TKR INSERT DUE TO INFECTION, SUSPECTED INFECTION CELLULITIS OCCUR FROM THE ANKLE.

  Patient problems: Cellulitis; Unspecified Infection

  MAUDE report 15317948 ↗
• InjuryJan 12, 2021Naturally Worn; Naturally Worn

  AS REPORTED: "PATIENT PRESENTED WITH ANTERIOR [RIGHT] KNEE PAIN. SURGEON STATES CT INDICATES PATELLA MAY BE LOOSE & OSTEOLYSIS DUE TO PATELLA & INSERT WEAR. SURGEON REPLACED PATELLA AND INSERT."

  Patient problems: Pain

  MAUDE report 11156668 ↗
• InjuryMay 11, 2020Loss of Osseointegration; Loss of Osseointegration

  INDEX AND REVISION. POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY (B)(6) 2015. PATIENT HAD MECHANICAL COMPLICATION WITH LOOSE PATELLA POLYETHYLENE IMPLANT, THE PATELLAR COMPONENT WAS REMOVED AND THE LINER WAS EXCHANGED (B)(6) 2018. REPORTED AS CORS PER 5171 KNEE. PATIENT UNDERWENT LEFT TOTAL KNEE REVISION FOR PJI WITH ALL COMPONENTS EXCHANGED IN (B)(6) 2019.

  Patient problems: Inadequate Osseointegration; Injury; Unspecified Infection

  MAUDE report 10044791 ↗
• InjuryMar 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. A 6X13 PS INSERT WAS SWAPPED FOR ANOTHER 6X13 PS INSERT. REP CAN PROVIDE AN EXPLANT PICTURE, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9799430 ↗
• InjuryAug 26, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A BROKEN POST ON THE PS INSERT. A 6X13 TRIATHLON PS INSERT WAS SWAPPED FOR ANOTHER 6X13 TRIATHLON PS INSERT. PATIENT'S ACTIVITY LEVEL WAS REPORTED AS VERY ACTIVE. THE EXPLANTED DEVICE IS AVAILABLE FOR RETURN AND THE SURGEON IS REQUESTING INVESTIGATION RESULTS.

  Patient problems: Injury

  MAUDE report 8932268 ↗
• MalfunctionJan 3, 2019Difficult to Insert; Defective Device; Difficult to Insert; Defective Device

  DURING A PRIMARY LEFT TKA WHILE INSERTING THE POLYETHYLENE INSERT IT WAS REPORTED TO ME THAT ¿THE LOCKING WIRE WAS STICKING OUT AFTER FULLY SEATING THE INSERT¿. A NEW INSERT WAS OPENED AND INSERTED SUCCESSFULLY. UPDATE 10/DECEMBER/2018: SURGICAL DELAY. AS REPORTED IN ADVERSE CONSEQUENCES DETAILS: "THE PROCEDURE WAS PROLONGED FOR AN EXTRA 2 MINUTES WHILE REMOVING THE AFFECTED INSERT AND IMPLANTING A NEW ONE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8214681 ↗
• InjuryJul 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO STIFFNESS. A POLY SWAP WITH SOFT TISSUE DEBRIDEMENT WAS PERFORMED. THE SURGEON FELT THE PATIENT HAD GOOD RANGE OF MOTION AS A RESULT. A SIZE 6, 13MM PS INSERT WAS EXCHANGED FOR A SIZE 6, 9MM INSERT.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 7722501 ↗
• InjuryDec 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  TOTAL KNEE ARTHROPLASTY REVISION DUE TO LAXITY 13MM INSERT EXPLANTED AND 16MM INSERT IMPLANTED.

  Patient problems: Injury

  MAUDE report 7148529 ↗