NA MWB216Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03700386969478), received between Aug 19, 2021 and May 2, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. How this data works · Data updated Oct 13, 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.

• InjuryMay 2, 2025Use of Device Problem; Material Deformation; Use of Device Problem; Material Deformation

  IT WAS REPORTED THAT THE SURGEON COULDN'T EXPLANT THE GLENOSPHERE. PATIENT HAD AN INFECTION. THE SURGERY WAS INITIALLY PROLONGED FOR 30 MINUTES AND EVENTUALLY CANCELLED.

  Patient problems: Insufficient Information

  MAUDE report 21952270 ↗
• MalfunctionMar 10, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A RSA REVISION GLENOSPHERE REMOVAL THE PHYSICIAN NOTICED THAT THE GLENOSPHERE DID NOT DISASSOCIATE WHEN HE ATTEMPTED TO UNTHREAD THE INSTRUMENT. WHEN IT CAME OUT THE INNER PIECE WAS BENT AT APPROXIMATELY A 45 DEGREE ANGLE. HE CORRECTED IT WITH THE RATCHETING CLAMP FROM THE EXTRACTION SET. HE THEN ASKED IF WE HAD ANOTHER DEVICE, AFTER WHICH HE TRIED USING THE MWB216 AND MWD148 COMBINATION. THE GLENOSPHERE DISASSOCIATED, BUT AFTER THE PROCEDURE THOSE TWO PIECES WERE STUCK TOGETHER AND THE MWJ130 INNER PORTION WAS NO LONGER TRACKING PROPERLY. NO DELAYS, OR COMPLICATIONS RESULTED FROM THE INSTRUMENTS BECOMING DAMAGED. HOWEVER, THEY DID NEEDED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13721443 ↗
• MalfunctionAug 19, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO TAKE THE SIZE 36 GLENOSPHERE OFF AND UPSIZE DUE TO STABILITY ISSUES THE PATIENT WAS HAVING. AFTER BACKING THE SET SCREW OUT AS FAR AS POSSIBLE THE SCREW CAME TO A POSITIVE STOP AND WOULD NO LONGER SPIN. THE SURGEON USED BOTH THE REVERSE II AND PERFORM REVERSE EXTRACTORS TO ATTEMPT TO REMOVE THE SPHERE BUT HE ENDED UP BREAKING THE FEET OF THE PERFORM REVERSE EXTRACTOR AND BENDING THE REVERSE II EXTRACTOR ATTEMPTING TO REMOVE THE SPHERE. THE SURGEON TRIED TO RE-ADVANCE THE SCREW DOWN JUST TO RESET EVERYTHING BUT WAS UNABLE TO DO SO AS THE SPHERE SCREW WAS STUCK AND WOULD NOT ADVANCE CLOCKWISE NOR COUNTERCLOCKWISE. WE NEEDED TO GO TO A 42 SPHERE TO LATERALIZE THE PATIENT FOR STABILITY BUT WE WERE UNABLE TO DO SO. THE 36 SPHERE IS STILL IN THE PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 12342864 ↗