Triathlon 5537-G-416Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327027235), received between Sep 28, 2018 and Aug 21, 2024 — classified as 7 injuries, 1 malfunction.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2024Unstable; Unstable

  PATIENT HAD A REVISION KNEE DONE IN GEORGIA POSSIBLY BACK IN 2020. FOR THE REVISION ON (B)(6) 2024: SHE HAD LAXITY AND WENT FROM A 4-16MM TO A 4-22 TS. NO POLY WEAR, PLOY LOOKED FINE. NO OTHER INFO IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 20022715 ↗
• InjuryJul 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "EXTREMITY LOWER IRRIGATION DEBRIDEMENT/ LINER EXCHANGE - RIGHT. PRE-OP DIAGNOSIS: INFECTION OF KNEE. NO FURTHER INFORMATION AVAILABLE PER HOSPITAL POLICY." A 4X16 TS INSERT WAS EXCHANGED FOR A 4X16 TS INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 12148690 ↗
• InjuryMay 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT HAD A SIGNIFICANT HISTORY OF RIGHT KNEE REVISION. PATIENT UNDERWENT KNEE REVISION, IRRIGATION AND DEBRIDEMENT AND SYNOVECTOMY TO TREAT ACUTE INFECTION OUTSIDE OF CORS SCOPE. PATIENT UNDERWENT TOTAL RIGHT REVISION TO TREAT THE DISFUNCTION AND ARTHROFIBROSIS, LINER WAS EXCHANGED (B)(6) 2016. REPORTED AS CORS PER 2920 KNEE. PATIENT HAD ACUTE INFECTION AFTER INFECTION FREE MANY YEARS. THEN PATIENT UNDERWENT RIGHT TOTAL KNEE REVISION, HAD REPLACEMENT FOR LINER SURGERY (B)(6) 2019. THE PATIENT UNDERWENT RIGHT TOTAL KNEE REVISION ONE COMPONENT, IRRIGATION DEBRIDEMENT OF OPEN WOUND. COMPLEX CLOSURE OF RIGHT KNEE WOUND ON (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 10043234 ↗
• InjuryMar 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED BY REP: "RIGHT KNEE EXPLANT DUE TO INFECTION." REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9898008 ↗
• InjuryJan 31, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT HAD A SIGNIFICANT HISTORY OF RIGHT KNEE REVISION. PATIENT UNDERWENT KNEE REVISION, IRRIGATION AND DEBRIDEMENT AND SYNOVECTOMY TO TREAT ACUTE INFECTION OUTSIDE OF CORS SCOPE ((B)(4)). PATIENT UNDERWENT TOTAL RIGHT REVISION TO TREAT THE DISFUNCTION AND ARTHROFIBROSIS, LINER WAS EXCHANGED (B)(6) 2016. REPORTED AS CORS PER2920KNEE. PATIENT HAD ACUTE INFECTION AFTER INFECTION FREE MANY YEARS. THEN PATIENT UNDERWENT RIGHT TOTAL KNEE REVISION, HAD REPLACEMENT FOR LINER SURGERY (B)(6) 2019.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9654071 ↗
• InjuryNov 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN. A 4X16 TS POLY WAS SWAPPED FOR ANOTHER 4X16 TS POLY.

  Patient problems: Injury; Pain

  MAUDE report 9340565 ↗
• InjuryOct 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS PI IS FOR THE REVISION OF THE PATIENT'S RIGHT KNEE DUE TO INFECTION ON (B)(6) 2019. PROCEDURE: THE PATIENT HAD A HISTORY OF INFECTED RIGHT KNEE REPLACEMENT OUTSIDE CORS SCOPE. PATIENT UNDERWENT RESECTION ARTHROPLASTY WITH ANTIBIOTIC CEMET SPACER TO TREAT THE INFECTION (B)(6) 2016 OFF-LABEL. PATIENT HAD SECOND STAGE INFECTION RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2016. PATIENT HAD MECHANICAL PROBLEM RIGHT TOTAL KNEE REVISION SURGERY (B)(6) 2017 RESECTION ARTHROPLASTY. PATIENT UNDERWENT CHRONICALLY INFECTED TOTAL KNEE ARTHROPLASTY REVISION WITH FEMORAL COMPONENT AND PATELLAR COMPONENT (B)(6) 2019.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9213431 ↗
• MalfunctionSep 28, 2018Component Missing; Component Missing

  STRYKER (B)(4) REP REPORTED THAT ON OPENING IMPLANT 5537-G-416 (TS TIBIAL INSERT, SIZE 4 X 16MM), IT WAS NOTED THAT THE METAL STABILIZING PIN USUALLY PACKED WITH THE INSERT WAS MISSING. ACCORDINGLY, AN ALTERNATIVE INSERT (5537-G-216) WAS OPENED TO USE THE PIN FROM THAT ONE. THERE WERE NO DELAY TO SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7920221 ↗