Tornier Perform MWJ128Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00846832062508), received between Sep 23, 2022 and Sep 23, 2022 — classified as 6 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WERE WAS AN INCISION AND DRAINAGE NEEDED FOR A PATIENT. THERE WAS PUSS AND PAIN REPORTED.

  Patient problems: Implant Pain; Purulent Discharge

  MAUDE report 15471601 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ENCOUNTERED AN INFECTION AND C ACNES WAS FOUND. THE PATIENT WAS REVISED WITH ANTIBIOTIC SPACER.

  Patient problems: Bacterial Infection

  MAUDE report 15471163 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE 59 YEAR OLD PATIENT HAD A REVERSE SHOULDER ARTHROPLASTY FOR A CUFF TEAR ARTHROPATHY. THERE IS A REVISION SURGERY NEEDED FOR A MSSA INFECTION. THE PATIENT HAS A HISTORY OF OPIOID USE AND EPIDURAL ABSCESS.

  Patient problems: Unspecified Infection

  MAUDE report 15471159 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A POST OP VISIT, THE PATIENT'S SHOULDER SHOWED PUSS. C ACNES WAS NOTED ON (B)(6) 2022. THERE WAS A REVISION TO THE ANTIBIOTIC SPACER.

  Patient problems: Bacterial Infection; Implant Pain; Purulent Discharge

  MAUDE report 15471132 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY FOR C ACNES AND THERE WAS AN INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 15470952 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD POST OPERATIVE PNEUMONIA. THERE WAS A WOUND DRAINAGE AND NO PLASTIC SPACER WAS USED.

  Patient problems: Pneumonia; Purulent Discharge

  MAUDE report 15470269 ↗