Triathlon 5537-G-313Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327027143), received between Feb 20, 2018 and Mar 27, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2024Device Damaged Prior to Use; Device Damaged Prior to Use

  THE RIM CONNECTED TO THE INSERT WAS COMPLETELY SEPARATED AND THE SAME SIZE WAS REPLACED AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18986189 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "KNEE PAIN STARTING (B)(6) 2021; COMPLAINED OF PAIN ISOLATED TO THE IT BAND; PAINFUL HARDWARE RELATED TO THE REPAIR OF THE INTRA-OP FRACTURE ALSO REMOVED DURING THE (B)(6) 2022 SURGERY." REVISION OPERATIVE REPORT PROVIDES THE FOLLOWING PREOPERATIVE DIAGNOSIS: "FAILED LEFT TOTAL KNEE ARTHROPLASTY; DUE TO GLOBAL INSTABILITY, RETAINED ORTHOPEDIC HARDWARE, LATERAL FEMORAL CONDYLE." ADDITIONALLY REPORTED UNDER INDICATIONS: "LEFT TOTAL KNEE ARTHROPLASTY; DUE TO GLOBAL INSTABILITY WITH RETAINED HARDWARE ON THE LATERAL FEMORAL CONDYLE FROM OVERNIGHT INTERNAL FIXATION. SHE HAS TENDERNESS PALPATION OVER THE HARDWARE. BASED ON THE PREOPERATIVE EXAM THERE IS SOME CONCERN WITH PSEUDOLAXITY." INFECTION WAS RULED OUT. REPORTED IN FINDINGS: "INTRAOPERATIVE FINDINGS WERE CONSISTENT WITH PREOPERATIVE IMAGING AND CLINICAL EVALUATION FROM THE PERSPECTIVE THAT THE HARDWARE WAS PRESENT ON THE LATERAL CONDYLE. HOWEVER PREOPERATIVE TESTING OF THE KNEE WITH THE PATIENT COMPLETELY ANESTHETIZED ON THE TABLE SHOWED LESS THAN 5 MM ANTERIOR TRANSLATION WITH THE KNEE AT 90 DEGREES AND ABSOLUTELY NO EVIDENCE OF MEDIAL OR LATERAL LAXITY IN FULL EXTENSION. IN MID FLEXION THERE WAS SOME SLIGHT LAXITY OF

  Patient problems: Pain

  MAUDE report 15751527 ↗
• MalfunctionNov 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE WIRE OF THE INSERT CAME OFF BEFORE INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12808422 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Injury

  MAUDE report 8568434 ↗
• InjuryFeb 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION. AN I&D WITH POLY SWAP WAS PERFORMED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7282499 ↗