Triathlon 5554-L-350Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327049909), received between May 9, 2017 and Apr 24, 2023 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO EFFUSION AND MAL-TRACKING OF THE PATELLA. INTRA-OPERATIVELY, IT WAS OBSERVED THAT THE POLY PORTION OF THE METAL-BACKED PATELLA HAD COMPLETELY SEPARATED FROM THE METAL. THE PATELLA WAS REVISED AND A DEBRIDEMENT PERFORMED. WHILE PERFORMING THE REVISION, THE SURGEON DECIDED TO EXCHANGE THE INSERT (NO ALLEGATIONS AGAINST THE REVISED INSERT).

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 16804111 ↗
• InjuryApr 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PATELLAR PAIN. A FEMORAL COMPONENT, PATELLAR COMPONENT, AND INSERT WERE REVISED. REP CONFIRMED THAT PICTURES CAN BE PROVIDED AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 14138777 ↗
• InjuryJun 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "PATIENT COMPLAINS OF GRINDING KNEE PAIN. ALL AVAILABLE INFORMATION SUBMITTED." A 6X9 CR X3 INSERT AND A35 METAL-BACKED PATELLA WERE REVISED.

  Patient problems: Injury; Pain

  MAUDE report 10142286 ↗
• InjuryFeb 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "PAIN AND CLICKING. ALL AVAILABLE INFORMATION SUBMITTED." REP PROVIDED PRE- REVISION X-RAYS, PICTURES OF THE EXPLANTED LINER AND PATELLAR COMPONENT, AND THE PRIMARY OPERATIVE REPORT.

  Patient problems: Injury; Pain

  MAUDE report 9671077 ↗
• InjurySep 17, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  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 DISASSOCIATE D 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 9075124 ↗
• InjuryJun 6, 2019Mechanical Problem; Noise, Audible; Mechanical Problem; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP, "PATIENT COMPLAINS OF ANTERIOR KNEE PAIN AND CLICKING." AN OFFICE VISIT NOTE REPORTS "I STRONGLY SUSPECT A MECHANICAL PROBLEM, NAMELY EXCESSIVE POLYETHYLENE WEAR FROM PROBABLY THE METAL BACK PATELLAR COMPONENT." THE PATELLAR DEVICE AND INSERT WERE REVISED. REP PROVIDED OPERATIVE REPORTS, IMPLANT REPORTS, PRE-REVISION X-RAYS AND AN EXPLANT PICTURE, AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 8675563 ↗
• InjuryMay 8, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED AFTER "PATIENT COMPLAINS OF PAIN, SWELLING, AND NOISE IN KNEE". AN OFFICE VISIT FROM (B)(6) 2019 STATES "...I THINK THE MORE LIKELY EXPLANATION IS DEFORMATION OR BREAKAGE OF ONE OR MORE OF THE PLASTIC COMPONENTS IN THE LEFT KNEE...". A 5X9 CR INSERT AND METAL-BACKED PATELLA WERE REVISED. REP PROVIDED AN OPERATIVE REPORT, PATIENT VITALS, PRE-REVISION X-RAYS, IMPLANT RECORDS, AND EXPLANT PICTURES AND REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury; Pain; Swelling

  MAUDE report 8592656 ↗
• InjuryJan 10, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO ANTERIOR PAIN. AN A35 BEADED PATELLA AND 7X9 CR INSERT WERE REVISED TO AN A35 X3 PATELLA AND 7X9 CR INSERT. REP PROVIDED PRIMARY OPERATIVE AND WEBOPS REPORTS, X-RAYS, AND VITALS AND REPORTED THAT ADDITIONAL X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY. UPDATE EVENT PER REVIEW OF THE PROVIDED PICTURE BY THE CONSULTING CLINICIAN: "PROVIDED PICTURE OF THE EXPLANTED PATELLA CONFIRMS WEAR."

  Patient problems: Injury; Pain

  MAUDE report 8232992 ↗
• InjuryDec 3, 2018Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. AN A35 PATELLA AND 5X13 CR INSERT WERE REVISED TO AN A38 PATELLA AND 5X16 CR INSERT. REP PROVIDED A PRIMARY OPERATIVE NOTE, WEBOPS REPORT OF THE PRIMARY IMPLANTS, EXAMINATION NOTE, PRE-REVISION X-RAYS, AND A PICTURE OF THE EXPLANTS AND REPORTED THAT ALL AVAILABLE INFORMATION HAS BEEN SUBMITTED. UPDATE: X-RAY FROM 8.17.2018 SHOW LATERAL PATELLA SUBLUXATION OF THE LEFT KNEE.

  Patient problems: Injury; Pain

  MAUDE report 8126544 ↗
• InjuryOct 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO PAIN IN ANTERIOR KNEE. A PATELLAR IMPLANT AND INSERT WERE REVISED.

  Patient problems: Injury; Pain

  MAUDE report 7980940 ↗
• InjuryAug 20, 2018Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED BY REP: "PAIN AND CLICKING IN ANTERIOR KNEE". AN A35 PATELLA AND 5/9 CR INSERT WERE REVISED TO AN A38 X3 PATELLA AND 5/11 CR INSERT.

  Patient problems: Injury; Pain

  MAUDE report 7797876 ↗
• InjuryJun 18, 2018Fracture; Fracture

  AS REPORTED: "PAIN IN ANTERIOR KNEE. POLY SWAP WHILE IN KNEE. ALL AVAILABLE INFORMATION SUBMITTED". EXPLANT PICTURES SHOW THAT THE PATELLAR IMPLANT SUFFERED VISIBLE DAMAGE. PATIENT WAS REVISED TO A 6/11 CR INSERT AND AN A35 X3 PATELLA.

  Patient problems: Injury; Pain

  MAUDE report 7611246 ↗
• InjuryMay 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT SURGEON REVISE PATIENT'S LEFT SIDE PATELLA DUE TO PAIN.

  Patient problems: Injury; Pain

  MAUDE report 6554275 ↗