Triathlon 5550-G-319Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327014761), received between Nov 12, 2018 and Aug 2, 2022 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO THE POST OF THE INSERT SHEARING OFF (SURGEON REPORTED THAT THE PATIENT WAS PRONE TO MULTIPLE FALLS). INTRA-OPERATIVELY, THE SURGEON NOTICED A HAIRLINE FRACTURE OF THE PATELLAR COMPONENT. WHILE ADDRESSING IT, THE PATELLAR COMPONENT BROKE IN HALF. A 6X9 PS INSERT WAS REVISED TO A 6X11 CS INSERT AND THE PATELLA WAS REVISED.

  Patient problems: Fall

  MAUDE report 15143480 ↗
• InjuryMay 9, 2022Unstable; Unstable

  PATIENT CALLED AND IS INQUIRING ABOUT RECALL FOR HER RIGHT KNEE SURGERY ON (B)(6) 2016. UPDATE (B)(6) 2022: PATIENT IS EXPERIENCING INSTABILITY. SHE HAS SEEN THREE DIFFERENT SURGEONS AND HAS UPCOMING REVISION SURGERY IN (B)(6). PATIENT WOULD LIKE TO KNOW WHAT IMPLANTS SHE CAN USE IN HER REVISION FOR A BETTER OUTCOME.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14342922 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT HAD BILATERAL SIMULTANEOUS INDEX TKA ON (B)(6) 2015. PATIENT COMPLAINS OF RIGHT ANTERIOR PAIN WITH PATELLAR LYSIS (SUSPICION OF PJI OR TUMOR). UNDERGOES REVISION ON (B)(6), 2021. NO INFECTION, OR TUMOR. EXCHANGED PATELLA AND LINER ONLY.

  Patient problems: Pain

  MAUDE report 12813473 ↗
• InjurySep 22, 2021Noise, Audible; Noise, Audible

  THIS PR WAS RAISED FROM THE MEDICAL REVIEW. THE DATE OF THE PROCEDURE WAS (B)(6) 2012. IN THE DISCHARGE SUMMARY IT NOTES THAT THE PATIENT WAS HAVING A POPPING SENSATION AROUND PATELLA AND WAS ADMITTED FOR EXPLORATION OF THE JOINT. SHE WAS NOTED TO HAVE EXTENSIVE SYNOVIAL HYPERTROPHY AND FIBROSIS AROUND THE PATELLA.

  Patient problems: Fibrosis; Synovitis

  MAUDE report 12514165 ↗
• InjuryNov 9, 2020Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY AS A RESULT OF A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2017 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY USING SIMPLEX HV BONE CEMENT. IT IS FURTHER ALLEGED THAT THE PATIENT WAS REVISED ON (B)(6) 2018 DUE TO ALLEGED LOOSENING OF HIS KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10814573 ↗
• InjuryNov 9, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THROUGH A LEGAL CLAIM THAT ALLEGEDLY ON (B)(6) 2018 THE PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY WITH SIMPLEX HV BONE CEMENT WITH GENTAMICIN. IT IS FURTHER ALLEGED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT REVISION SURGERY DUE TO ALLEGED LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 10807873 ↗
• InjuryJun 11, 2019Unstable; Unstable

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO " FAILED RIGHT TOTAL KNEE ARTHROPLASTY FOR INSTABILITY".

  Patient problems: Injury

  MAUDE report 8687090 ↗
• InjuryMar 18, 2019Unstable; Insufficient Device Problem Information; Unstable; Insufficient Device Problem Information

  AS REPORTED: "DOCTOR REVISED INSERT AND PATELLA DUE TO INSTABILITY. NO MORE INFORMATION AVAILABLE". SPOKE TO REP. HOSPITAL WILL NOT ALLOW THE RELEASE OF ANY FURTHER INFORMATION.

  Patient problems: Injury

  MAUDE report 8429167 ↗
• InjuryFeb 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "THE PATIENT EXPERIENCED A LOT OF PAIN WHEN STANDING UP, SITTING DOWN, AND WHEN WALKING. THE PATELLA IMPLANT FAILED TO TRACK PROPERLY ON THE AVON PATELLOFEMORAL COMPONENT. WE CONVERTED INTO A PRIMARY PS TRIATHLON KNEE". REP REPORTED THAT HOSPITAL WOULD NOT RELEASE X-RAYS TO STRYKER.

  Patient problems: Pain

  MAUDE report 8357502 ↗
• InjuryNov 12, 2018Loss of Osseointegration; Loss of Osseointegration

  PATIENT REPORTED HE IS EXPERIENCING LOOSENING AND PAIN AFTER HIS RIGHT KNEE SURGERY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 8060113 ↗