Triathlon 5537-G-316Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327027150), received between Feb 16, 2018 and Nov 27, 2020 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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.

• InjuryNov 27, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SURGEON PERFORMED A POLY SWAP OF THE PATIENT'S RIGHT KNEE DUE TO INFECTION. REP PROVIDED THE USAGE SHEET FROM THE PRIOR PROCEDURE AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 10913893 ↗
• InjuryAug 27, 2020Mechanical Problem; Mechanical Problem

  THIS PI IS FOR THE POLY SWAP WITH I&D ON (B)(6) 2020: PROCEDURE: THE PATIENT HAD DIFFICULTIES WITH THE RIGHT KNEE DUE TO MECHANICAL FAILURE. PATIENT UNDERWENT A REVISION OF THE RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2013. PATIENT UNDERWENT RIGHT KNEE REVISION TO TREAT THE PAIN ALL COMPONENTS EXCHANGED IN (B)(6) 2015 REPORTED AS CORS PER 1473KNEE. PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT WITH REVISION OF POLY INSERT AND INCISION AND DRAINAGE AND SYNOVECTOMY FOR RIGHT INFECTED TOTAL KNEE REPLACEMENT (B)(6) 2020.

  Patient problems: Injury; Pain

  MAUDE report 10459229 ↗
• InjuryAug 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AN IRRIGATION & DEBRIDEMENT WAS PERFORMED AND A 3X16 TS POLY WAS SWAPPED FOR ANOTHER 3X16 TS POLY. REP PROVIDED USAGE SHEETS AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10399597 ↗
• InjuryAug 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. SURGEON REPORTED THE INFECTING MICROORGANISM IS PROPIONIBACTERIUM ACNES (P ACNES). ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP PROVIDED USAGE SHEETS AND EXPLANT PICTURES, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10377962 ↗
• InjurySep 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REQUIRED A RIGHT TOTAL KNEE REVISION DUE TO PAIN AND STIFFNESS , ARTHROFIBROSIS FROM A PREVIOUS SURGERY ON (B)(6) 2018.

  Patient problems: Fibrosis; Injury; Pain

  MAUDE report 8955494 ↗
• InjuryApr 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  SURGEON PERFORMED AN I&D WITH A TRIATHLON TIBIAL INSERT EXCHANGE DUE TO INFECTION ON A RIGHT KNEE. THE ORIGINAL PRIMARY SURGERY WAS ON (B)(6) 2019. UPDATE 01/APRIL/2019: REP PROVIDED AN EXCERPT FROM THE PRIMARY OPERATIVE REPORT AND THE REVISION USAGE SHEET AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8556201 ↗
• InjurySep 17, 2018Unstable; Unstable

  PATIENT COMPLAINED OF LAXITY AND PAIN IN THEIR RIGHT KNEE. PATIENT HAD REVISION SURGERY PRIOR AND ANOTHER REVISION WAS DONE TODAY. POLY INSERT WAS REPLACED ALONG WITH PATELLA. A TRIATHLON TS INSERT 3X25 MM WAS IMPLANTED AND A 35 MM ASYMMETRIC PATELLA TODAY.

  Patient problems: Injury; Pain

  MAUDE report 7882619 ↗
• InjuryApr 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REP REPORTED A REVISION OF PATIENT'S RIGHT KNEE.

  Patient problems: Injury

  MAUDE report 7451881 ↗
• InjuryFeb 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION (SURGEON REPORTED INFECTION WAS CLINICALLY CONFIRMED BUT DID NOT IDENTIFY THE INFECTING MICROORGANISM) AFTER PATIENT SUSTAINED A CUT ON HER KNEE. AN I&D WITH POLY EXCHANGE WAS PERFORMED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7276906 ↗