Triathlon 5512-F-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327026085), received between Oct 2, 2018 and Mar 22, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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.

• InjuryMar 22, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  STEM DISASSOCIATED FROM THE RIGHT FEMORAL COMPONENT. REQUIRED REVISION SURGERY. NO ALLEGATIONS AGAINST THE INSERT OR AUGMENT.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation

  MAUDE report 13844990 ↗
• InjuryJul 7, 2021Degraded; Fracture; Loss of Osseointegration; Degraded; Fracture; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO A BROKEN STEM. A 100MM X 15MM TRIATHLON STEM AND SIZE 4 FEMORAL COMPONENT WERE REVISED. UPDATE PER MEDICAL REVIEW: ADVERSE EVENT IDENTIFIED: FAILURE OF A FEMORA IMPLANT-STEM CONSTRUCT AT THE THREADED JUNCTION LEADING TO COMPLEX REVISION SURGERY.

  Patient problems: Ambulation or Postural Difficulties; Fall; Inadequate Osseointegration; Metal Related Pathology; Pain

  MAUDE report 12127873 ↗
• InjuryMay 27, 2021Loss of Osseointegration; Loss of Osseointegration

  IN PERFORMING FOLLOW-UP, REP PROVIDED A REVISION OPERATIVE REPORT FOR (B)(6) 2013 FOR THE PATIENT'S RIGHT KNEE. PREOPERATIVE DIAGNOSIS: LOOSE RIGHT REVISION KNEE ARTHROPLASTY WITH MALTRACKING OF PATELLA. OP REPORT NOTES: "IN LESS THAN 1 YEAR SHE DEVELOPED INCREASING PAIN AND DISCOMFORT. STUDIES ARE SUSPICIOUS FOR POSSIBLE LOOSENING OF FEMORAL COMPONENT. THERE WAS ONLY SOME DISTAL CEMENT AROUND THE FEMORAL COMPONENT. THE STEM APPEARED TO BE REACTIVE LINE AROUND IT SUGGESTING LOOSENING OF FEMORAL COMPONENT...THE PATELLA WAS ALSO TILTING AND MALTRACKING¿FEMORAL COMPONENT CAME OUT VERY EASILY WITH NO FIXATION AT ALL. THE CEMENT WAS BONDED TO THE IMPLANT WITH AUGMENTS. THE STEM CAME OUT AND THERE WAS A FIBROUS MEMBRANE AROUND THE STEM COMPLETELY. THERE WAS NO CEMENT ON THE STEM AT ALL CONSISTENT WITH FEMORAL COMPONENT LOOSENING...WE HAD TO REMOVE THE PATELLAR COMPONENT TO POSITION IT MORE CENTRALLY..."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 11899109 ↗
• InjuryApr 8, 2021Loss of Osseointegration; Loss of Osseointegration

  PATIENTS REVISION KNEE WAS REVISED FOR FEMORAL LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11633218 ↗
• InjuryOct 27, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY. SURGEON'S ORIGINAL PLAN WAS TO REVISE THE POLY INSERT, BUT INTRA-OPERATIVELY DECIDED TO REVISE THE FEMORAL COMPONENT AS WELL. A SIZE 4 TS FEMORAL COMPONENT WITH STEM AND AUGMENTS, AND A SIZE 4 TS INSERT WERE REVISED TO A SIZE 4 TS FEMORAL COMPONENT WITH A STEM, CONES, AND AUGMENTS, AND A 4X19 TS INSERT. REP PROVIDED EXPLANT PICTURES AND REVISION USAGE SHEET, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity

  MAUDE report 10744729 ↗
• InjuryApr 16, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "THIS IS A REVISION TO A REVISION DONE ON (B)(6) 2016 [(B)(6) 2016 REVISION WAS OF COMPETITOR DEVICES]... THE CURRENT REVISION WAS DUE TO A SUSPECTED LOOSE FEMORAL COMPONENT, AS STATED BY SURGEON". A SIZE 4 TS FEMORAL COMPONENT WITH STEM AND AUGMENTS, AND A TS INSERT WERE REVISED TO ANOTHER SIZE 3 TS FEMORAL COMPONENT WITH STEM AND STEM EXTENDER, AUGMENTS, AND ANOTHER TS INSERT. REP PROVIDED IMPLANT SHEETS FROM CURRENT AND PREVIOUS REVISION, PRE-REVISION X-RAYS, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8520374 ↗
• InjuryOct 2, 2018Migration; Migration

  IT WAS REPORTED PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING OF THE FEMORAL COMPONENTS. A SIZE 4 FEMORAL COMPONENT ALONG WITH A PRESS-FIT STEM WHICH WAS CEMENTED IN (MANUFACTURER OF CEMENT UNKNOWN) ALONG WITH A SIZE 7 28MM INSERT WERE REMOVED.

  Patient problems: Injury

  MAUDE report 7927302 ↗