NA 1294-56-131Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295026723), received between Oct 3, 2017 and Mar 27, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. SURGEON REMOVED EVERYTHING. DOI: (B)(6) 2019, (B)(6) 2019 (INSERT). DOR: (B)(6) 2020.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9891546 ↗
• MalfunctionDec 18, 2017Break; Break

  IT WAS REPORTED THAT WHILE ATTEMPTING TO ASSEMBLE THE WEDGE TO TRAY, THE TIP OF THE WOBBLE BIT WAS BROKE OFF. SURGICAL DELAY- 1 MINUTE. DOE: (B)(6) 2017.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7125180 ↗
• MalfunctionOct 3, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED DURING THE CASE, THE SURGEON OPENED THE MBT REVISION 10MM SIZE 3 AUGMENT FROM THE STERILE INTERNAL PACKAGING AND THE IMPLANT HAD A WHITE LOOKING POWDER ON THE SURFACE, TOOK A PICTURE OF THE WHITE POWDER ON THE IMPLANT AND THEN IT WAS RINSED WITH STERILE SALINE. SINCE WE IMPLANTED 2 EACH, SIZE 3 10MM AUGMENTS WE WEREN'T SURE WHICH LOT NUMBER HAD THE WHITE POWDER. BOTH LOT NUMBERS ARE INCLUDED BELOW.

  Patient problems: No Information

  MAUDE report 6911724 ↗