Triathlon 5531-G-211Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327045666), received between Dec 29, 2017 and Jun 30, 2024 — classified as 7 injuries, 1 malfunction.

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.

• InjuryJun 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENTS RIGHT KNEE WAS REVISED DUE TO LIGAMENT LAXITY. A 2X11 INSERT WAS REPLACED WITH A 2X13 INSERT. THERE ARE NO ALLEGATIONS AGAINST IMPLANT. NO FURTHER INFORMATION AVAILABLE AS PER HOSPITAL POLICY.

  Patient problems: Joint Laxity

  MAUDE report 19640940 ↗
• InjuryJul 27, 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 DISCOMFORT. A 2X11 CS POLY WAS REVISED TO A 2X9 CS POLY.

  Patient problems: Discomfort

  MAUDE report 17403994 ↗
• InjuryMar 29, 2023Loss of Osseointegration; Noise, Audible; Loss of Osseointegration; Noise, Audible

  PATIENT REPORTED JOINT LOOSENING AND AUDIBLE NOISE FOLLOWING PRIMARY TRIATHLON LEFT KNEE SURGERY. PATIENT STATED THAT SYMPTOMS STARTED "IMMEDIATELY" FOLLOWING THE FEBRUARY 2020 SURGERY AND THAT THE KNEE WAS"NEVER GOOD". PATIENT STATED SHE FEELS THE LOOSENING AND DID NOT STATE WHETHER HER SURGEON CONFIRMED THE LOOSENING. PATIENT STATED THAT THE JOINT NOISE IS HEARD WHEN SHE MOVES HER "TOES UP AND DOWN".

  Patient problems: Inadequate Osseointegration

  MAUDE report 16640579 ↗
• InjuryFeb 28, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED DUE TO PAIN AND INSTABILITY. X-RAY NOTES INDICATE "LATERAL VIEWS HOWEVER DEMONSTRATE LEFT KNEE POSTERIOR SUBLUXATION OF FEMUR ON TIBIA NOT SEEN ON RIGHT SIDE AND SUGGESTIVE OF POSTERIOR CRUCIATE LIGAMENT INSUFFICIENCY." A CR FEMORAL COMPONENT AND CS INSERT WERE REVISED TO A PS FEMORAL COMPONENT AND PS INSERT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16451603 ↗
• InjuryMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT LEFT INDEX TKA ON (B)(6) 2017. PATIENT PRESENTS WITH PAIN AND IS STUDIED FOR INFECTION. SHE IS REVISED FOR PJI ON (B)(6) 2021. ALL COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 13732752 ↗
• MalfunctionFeb 6, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT DURING THE SURGICAL CASE, THE DOCTOR TRY TO PUT THE TIBIAL BEARING INSERT - CS SIZE 2 (PN: 5531-G-211) INTO THE PATIENT'S LEFT KNEE BUT IT WAS NOT FIT SUITABLY. SO, THE DOCTOR DECIDED TO USE ANOTHER ONE, TIBIAL BEARING INSERT - CS SIZE 2 (PN: 5531-G-211), BUT THIS ONE CAN BE INSERTED INTO PATIENT'S LEFT KNEE AND THE CASE WAS DONE COMPLETELY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9676684 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "PATIENT PRESENTED WITH POSSIBLE SINUS TRACT [A NARROW CHANNEL IN THE BODY THAT ALLOWS THE RELEASE OF FLUID] IN INCISION OF PREVIOUS SURGERY. PATIENT WAS WASHED OUT AND THE LINER WAS EXCHANGED. A SIZE 2 11MM CS INSERT WAS REMOVED AND SWAPPED OUT FOR A NEW ONE".

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7711211 ↗
• InjuryDec 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: PATIENT UNDERWENT IRRIGATION AND DEBRIDEMENT FOR PJI WITH EXCHANGE OF POLY LINER ONLY.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7154424 ↗