Triathlon 5532-G-211Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327046212), received between Feb 13, 2019 and Jul 9, 2025 — classified as 5 injuries, 2 malfunctions.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AS PART OF AN INVESTIGATOR INITIATED STUDY, A SPREADSHEET WAS PROVIDED INDICATING THAT AN MUA WAS PERFORMED ON THE PATIENT'S RIGHT KNEE.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 22458680 ↗
• MalfunctionAug 2, 2022Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem; Inadequacy of Device Shape and/or Size; Device Markings/Labelling Problem

  INSERT SIZE IS DIFFERENT. THERE SHOULD BE AN 11MM PRODUCT WHEN OPENED, BUT THERE WAS AN ESTIMATED 9MM PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152757 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT, SHE HAD BILATERAL TKA DONE ON (B)(6) 2011. THE PATIENT STATED SHE STARTED TO EXPERIENCE PAIN ON BOTH KNEES SINCE HER SURGERY. PATIENT STATED ITS HARD TO GET UP AND DOWN FROM A CHAIR. THE PATIENT STATED HER RIGHT KNEE IS WORSE THAN THE LEFT. PATIENT'S RIGHT KNEE WAS REVISED ON (B)(6) 2013. THE PATIENT STATED SHE IS STILL EXPERIENCING PAIN ON BOTH KNEES AND HER PAIN HASN'T GOTTEN BETTER. PATIENT IS NOT ABLE TO CLIMB STEPS WITHOUT ASSISTANCE. THIS PI FOR THE LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 14186937 ↗
• InjuryMar 2, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO INSTABILITY. A 2X9 PS INSERT WAS REVISED TO A 2X16 TS INSERT. REP CONFIRMED THAT THERE WERE NO ALLEGATIONS OR INTRA-OP OBSERVATIONS AGAINST THE REVISED LINER - THE PATIENT'S JOINT/ TISSUES HAD SIMPLY BECOME LOOSE OVER TIME, THERE WAS NO DEVICE LOOSENING. REP ALSO CONFIRMED THAT NO FURTHER INFORMATION WILL BE PROVIDED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 9775528 ↗
• InjuryJan 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT'S RIGHT PATELLA WAS RESURFACED. WHILE PERFORMING THE RESURFACING, SURGEON DECIDED TO REVISE THE 2X11 PS INSERT TO A 2X13 PS INSERT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT, PROVIDED THE REVISION USAGE SHEET, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 9555849 ↗
• InjuryJul 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT BILATERAL TOTAL KNEE REPLACEMENT (B)(6) 2017. PATIENT HAD RIGHT KNEE MECHANICAL COMPLICATION WITH DISLOCATED AND FRACTURED RIGHT [NATIVE] PATELLA DUE TO PATELLA INSUFFICIENCY. PATIENT UNDERWENT RIGHT TOTAL KNEE REVISION (B)(6) 2019.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8821576 ↗
• MalfunctionFeb 13, 2019Difficult to Insert; Difficult to Insert

  IT WAS REPORTED BY THE SALES REP THAT DURING THE OPERATION, SURGEON USED INSERT IMPACTOR TO PUSH TIBIA INSERT INTO LOCKING MECHANISM OF TIBIA TRAY BUT THE TIBIA INSERT COULD NOT BE LOCKED WITH THE TIBIA TRAY ( TIBIA INSERT WAS NOT FIT WITH THE TIBIA TRAY). SO SURGEON DECIDED TO REMOVE THE TIBIA INSERT AND A NEW TIBIA INSERT WAS USED IMMEDIATELY. THE CASE WAS COMPLETED SUCCESSFULLY AND NO DELAY IN THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8336174 ↗