TORNIER PERFORM™ HUMERAL SYSTEM DWP2396Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00846832084500), received between Nov 10, 2021 and Nov 10, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 10, 2021Difficult to Insert; Difficult to Insert

  THE SURGEON IMPLANTED THE PERFORM HUMERAL #3 STANDARD STEM IN THE PATIENT AND WHILE ATTEMPTING TO IMPACT THE 39MM + 6 REVERSE INSERT HE COULDN¿T SUCCESSFULLY SEAT IT INTO THE STEM. AFTER SEVERAL ATTEMPTS IT WAS DECIDED TO OPEN A SECOND REVERSE INSERT. PRIOR TO ATTEMPTING TO IMPLANT THE SECOND REVERSE INSERT THE HUMERAL CUT SURFACE WAS INSPECTED, TRIMMED & REAMED TO ASSURE THAT THERE WAS NOTHING BLOCKING THE INSERT TO SEAT CORRECTLY. ON THE SECOND REVERSE IMPLANT ATTEMPT THE SURGEON EXPERIENCED THE SAME ISSUES AND ENDED UP DROPPING THE SECOND IMPLANT TO THE FLOOR. THE SURGEON THEN EXPLANTED THE PERFORM HUMERAL STEM AND ATTEMPTED SEVERAL TIMES TO IMPACT THE REVERSE INSERT THAT WAS OPENED THE FIRST TIME ON THE BACK TABLE WITH THE IMPACTION STAND WITHOUT SUCCESS. AT THAT TIME, HE ASKED FOR A NEW PERFORM HUMERAL STEM TO BE OPENED AND REVERSE INSERT. THE NEW PERFORM HUMERAL STEM AND INSERT WAS IMPLANTED WITHOUT ANY PROBLEMS. THIS WHOLE TROUBLESHOOTING PROCESS PROBABLY ADDED 20-30 MINUTES TO THE SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787414 ↗
• MalfunctionNov 10, 2021Positioning Failure; Positioning Failure

  THE SURGEON IMPLANTED THE PERFORM HUMERAL #3 STANDARD STEM IN THE PATIENT AND WHILE ATTEMPTING TO IMPACT THE 39MM + 6 REVERSE INSERT HE COULDN¿T SUCCESSFULLY SEAT IT INTO THE STEM. AFTER SEVERAL ATTEMPTS IT WAS DECIDED TO OPEN A SECOND REVERSE INSERT. PRIOR TO ATTEMPTING TO IMPLANT THE SECOND REVERSE INSERT THE HUMERAL CUT SURFACE WAS INSPECTED, TRIMMED & REAMED TO ASSURE THAT THERE WAS NOTHING BLOCKING THE INSERT TO SEAT CORRECTLY. ON THE SECOND REVERSE IMPLANT ATTEMPT THE SURGEON EXPERIENCED THE SAME ISSUES AND ENDED UP DROPPING THE SECOND IMPLANT TO THE FLOOR. THE SURGEON THEN EXPLANTED THE PERFORM HUMERAL STEM AND ATTEMPTED SEVERAL TIMES TO IMPACT THE REVERSE INSERT THAT WAS OPENED THE FIRST TIME ON THE BACK TABLE WITH THE IMPACTION STAND WITHOUT SUCCESS. AT THAT TIME, HE ASKED FOR A NEW PERFORM HUMERAL STEM TO BE OPENED AND REVERSE INSERT. THE NEW PERFORM HUMERAL STEM AND INSERT WAS IMPLANTED WITHOUT ANY PROBLEMS. THIS WHOLE TROUBLESHOOTING PROCESS PROBABLY ADDED 20-30 MINUTES TO THE SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787411 ↗