Triathlon 5554-L-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327049893), received between Jun 12, 2017 and Jun 29, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2022Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PAIN AND DEFORMITY. " A BASEPLATE, INSERT, AND PATELLAR COMPONENT WERE REVISED.

  Patient problems: Deformity/ Disfigurement; Pain

  MAUDE report 14864671 ↗
• InjuryFeb 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PLASTIC SHEARING OFF OF METAL PORTION OF THE PATELLAR COMPONENT. NO POSSIBLE CAUSE OR CONTRIBUTOR WAS REPORTED TO THE REP. REP CAN PROVIDE SOME PICTURES, BUT CONFIRMED THAT OTHERWISE NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11386971 ↗
• InjuryApr 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF LEFT KNEE DUE TO POPPING AND PAINFUL SENSATION. ORIGINAL SURGERY WAS (B)(6) 2010. PICTURES OF EXPLANTED IMPLANTS WERE PROVIDED. NO FURTHER INFORMATION WILL BE PROVIDED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Pain

  MAUDE report 8525129 ↗
• InjuryDec 28, 2018Material Deformation; Material Deformation

  AS REPORTED: "PATIENT COMPLAINED OF PAIN AND CLICKING IN KNEE. ALL AVAILABLE INFORMATION SUBMITTED". EXPLANT PICTURE PROVIDED BY THE REP SHOWS A METALBACK PATELLA WITH ITS POLY PORTION EXHIBITING NOTABLE DAMAGE. AN A32 METALBACK PATELLA AND 3X9 INSERT WERE REVISED TO AN A32 X3 PATELLA AND 3X11 CR INSERT.

  Patient problems: Injury; Pain

  MAUDE report 8204590 ↗
• InjuryNov 27, 2018Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED THROUGH MW5078695 "PATIENT REPORTS SHE WAS UNABLE TO GET UP FROM HER BED ONE MORNING DUE TO SEVERE PAIN IN HER KNEE. SHE REPORTS HEARING CLICKS WHILE WALKING AND HAS EXPERIENCED WEAKNESS, SWELLING AND BUCKLING. HER ORTHOPEDIC SURGEON SAW "SOMETHING STICKING OUT OF HER BONE" AND MENTIONED THAT "SOMETHING PULLS AWAY" WHEN SHE MOVES HER KNEE. THE PATIENT IS WEARING A KNEE BRACE FOR SUPPORT AND CAN NO LONGER HEAR THE CLICKING NOISE; HOWEVER, HER OTHER SYMPTOMS PERSIST" UPDATE (B)(6) 2018: RIGHT KNEE LOOSENING.

  Patient problems: Ambulation or Postural Difficulties; Inflammation; Pain; Swelling; Weakness

  MAUDE report 8105554 ↗
• InjuryJun 12, 2017Fracture; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY WITH TRIATHLON PATELLA PA WAS PERFORMED ON (B)(6) 2017. AFTER THAT FRACTURE OF THE PATELLA WAS FOUND, THE REVISION SURGERY IS PLANNED ON (B)(6) 2017.

  Patient problems: Bone Fracture(s); Injury; No Code Available

  MAUDE report 6633178 ↗