Triathlon 5537-G-522Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327027341), received between Jan 14, 2020 and Nov 14, 2021 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION ON (B)(6) 2021. PATIENT HAD LEFT INDEX TKA (OUTSIDE OF CORS SCOPE). PATIENT HAS HAD MULTIPLE REVISIONS (OUTSIDE OF CORS SCOPE) FOR INSTABILITY. ON (B)(6) 2021 THE PATIENT IS ADMITTED FOR REVISION DUE TO INSTABILITY. UNDERGOES REVISION OF ALL COMPONENTS. ON (B)(6) 2021 THE PATIENT PRESENTS WITH LEFT PJI AND IS REVISED WITH EXCHANGE OF POLY ONLY AND WITH ANTIBIOTIC LOADED CEMENT FOR TREATMENT. ON (B)(6) 2021, THE PATIENT UNDERGOES SECOND REVISION FOR LEFT PJI WITH POLY EXCHANGE ONLY.

  Patient problems: Unspecified Infection

  MAUDE report 12808416 ↗
• InjuryNov 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A POLY SWAP WAS DONE DUE TO INFECTION. A 5 X 22 TS INSERT WAS SWAPPED FOR ANOTHER OF THE SAME SIZE AND TYPE. PRIMARY USAGE SHEET MAY BE AVAILABLE, BUT REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. THE SAME (LEFT) KNEE WAS PREVIOUSLY REVISED ON (B)(6) 2020 FOR INSTABILITY.

  Patient problems: Unspecified Infection

  MAUDE report 10884748 ↗
• InjuryOct 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  TKA TESTED POSITIVE FOR A STAPH INFECTION AND AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED ALONG WITH A POLY EXCHANGE.

  Patient problems: Bacterial Infection

  MAUDE report 10654417 ↗
• InjuryJan 14, 2020Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INSTABILITY CAUSED BY A STRETCHED LIGAMENT. A 5X22 TS INSERT WAS EXCHANGED FOR A 5X25 TS INSERT. REP REPORTED THAT HE MAY BE ABLE TO PROVIDE PRIMARY AND REVISION USAGE, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9588480 ↗