Triathlon 5530-G-211Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327045444), received between Apr 17, 2019 and Dec 11, 2024 — classified as 9 injuries.

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.

• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT REVISION OF MAKO TKA WAS DONE ON (B)(6) 2024 DUE TO SEPTIC ARTHRITIS. WASHOUT AND REPLACEMENT OF CR LINER WAS DONE. THE INITIAL PRIMARY SURGERY WAS DONE IN YEAR 2019.

  Patient problems: Arthritis; Sepsis; Unspecified Infection

  MAUDE report 20900239 ↗
• InjuryMar 19, 2021Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO SIGNIFICANT LATERAL INSTABILITY AND SUBLUXATION. INTRA-OPERATIVELY, IT WAS OBSERVED THAT THE INSERT WAS SIGNIFICANTLY WORN POSTERIORLY. THE PATIENT WAS REVISED FROM A 2X11 CR INSERT TO A 2X19 CS INSERT. REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11523033 ↗
• InjuryNov 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO JOINT LAXITY. A 2X11 CR INSERT WAS REVISED TO A 2X16 CR INSERT. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9268413 ↗
• InjurySep 17, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED AFTER PATIENT COMPLAINT OF PAIN AND CLICKING. INTRA-OPERATIVELY, THE POLY PART OF THE PATELLAR COMPONENT WAS FOUND TO HAVE A PORTION BROKEN OFF AND ALL OF THE POLY DISASSOCIATED FROM THE METAL PART OF THE PATELLAR COMPONENT. THE 2X11 CR INSERT WAS ALSO REVISED AFTER WEAR WAS NOTED. THE PATIENT WAS REVISED TO AN ALL POLY PATELLAR COMPONENT AND A NEW INSERT OF THE SAME CATALOG NUMBER. REP PROVIDED AN INTRA-OP PICTURE AND EXPLANT PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Joint Dislocation; Pain

  MAUDE report 9075126 ↗
• InjurySep 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE SYNOVECTOMY AND DEBRIDEMENT OF SCAR TISSUE ON (B)(6) 2016. MEDICAL REVIEW FOR (PATIENT RIGHT KNEE REVISION (B)(6) 2016) STATES: "SHE HAD ARTHROSCOPY OF THE RIGHT KNEE ARTHROPLASTY WAS PERFORMED WITH ALMOST COMPLETE SYNOVECTOMY OF THE KNEE AND DEBRIDEMENT OF SCAR TISSUE ON (B)(6) 2016 BEFORE EXPLANTING AND IMPLANTING [COMPETITOR] COMPONENTS ON (B)(6) 2016.

  Patient problems: Injury; Scar Tissue; Unspecified Infection

  MAUDE report 9070608 ↗
• InjuryJul 2, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "INSTABILITY, LEFT KNEE".

  Patient problems: Injury

  MAUDE report 8755189 ↗
• InjuryJul 2, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "FAILED RIGHT TOTAL KNEE ARTHROPLASTY" UPDATE (B)(6) 2019 AS PER MEDIAL REVIEW: SUBOPTIMAL INITIAL DEVICE FIXATION THROUGH INCOMPLETE CEMENTATION OF THE TIBIAL BASEPLATE HAS CONTRIBUTED TO LOOSENING REQUIRING REVISION SURGERY. IT WOULD BE QUITE LIKELY THAT A LATE ONSET LOW- GRADE INFECTION OF HEMATOGENOUS ORIGIN HAS CONTRIBUTED AS WELL TO FAILURE WHILE PRIOR TO REVISION AN EXTENSIVE ARTHROSCOPIC DEBRIDEMENT OF THE KNEE MAY HAVE CONTRIBUTED TO INCREASED LIGAMENT LAXITY THEREBY INCREASING COMPLAINTS REQUIRING MORE EARLY INTERVENTION WITH REVISION SURGERY OF ALL COMPONENTS, REPLACED WITH COMPETITOR DEVICES WITH AN ADEQUATE END RESULT.

  Patient problems: Injury

  MAUDE report 8753118 ↗
• InjuryApr 18, 2019Naturally Worn; Naturally Worn

  AS REPORTED: "THE PATIENT'S CR POLY INSERT SUFFERED FROM SIGNIFICANT WEAR. WE REPLACED THE 2X11 CR INSERT WITH 2X16 CS INSERT. THIS WAS A RIGHT KNEE".

  Patient problems: Injury

  MAUDE report 8527934 ↗
• InjuryApr 17, 2019Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUBLUXATION. THE POSTERIOR PORTION OF THE POLY FRACTURED OFF, WHICH CAUSED THE SUBLUXATION. THE PIECE OF THE POLY WAS IN THE JOINT SPACE AND DAMAGED THE PATELLAR COMPONENT. SURGEON REVISED PATELLAR COMPONENT AND CR POLY WAS REVISED TO A CS 2X13 POLY. REP REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8522735 ↗