GLOBAL UNITE 2100-50-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295416098), received between Nov 21, 2017 and Oct 1, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2019Break; Break

  AFTER STERILIZATION THE DEFECT WAS NOTICED, COLOR RING OF PROXIMAL BODIES IS LOOSE AND PARTLY DETACHED AND COLOR IS DETACHED FROM THE BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9139657 ↗
• MalfunctionMay 24, 2019Break; Peeled/Delaminated; Break; Peeled/Delaminated

  IT WAS REPORTED THAT THEY HAD SOME PAINT COMING OFF TWO SEPARATE TRIALS. HOSPITALS WOULD NOT LET THEM USE IN CASES AND NEED TO BE REPLACED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8641281 ↗
• MalfunctionOct 8, 2018Material Discolored; Material Discolored

  THE INSTRUMENTS ARE WORN OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7944349 ↗
• MalfunctionJun 5, 2018Component Missing; Component Missing

  IT WAS REPORTED THAT UPON RETRIEVING INSTRUMENTS FROM THE WASHER STERILIZER THE DAY FOLLOWING THE SURGERY, THEY NOTICED ONE OF THE NECK SEGMENTS LOST ITS COLORED RING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7569495 ↗
• MalfunctionMar 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PAINT RING AROUND THE TRIAL BODY SIZE 14 145 DEGREE CHIPPED OFF. NO PIECES FELL INTO THE PATIENT SO NOTHING WAS NEEDED TO BE RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7348197 ↗
• MalfunctionJan 3, 2018Material Discolored; Flaked; Material Discolored; Flaked

  DER STATES THAT GREEN RING AROUND THE NECK OF THE SIZE 14 HUMERAL PROXIMAL BODY TRIAL FLUFFED OFF IN THE PATIENT DURING REDUCTION TRIAL. ALL PIECES WERE RECOVERED. NO ITEMS REMAINED IN THE PATIENT. SURGERY TIME WAS DELAYED ONLY BY THE AMOUNT OF TIME IT TOOK TO RECOVER GREEN COLOR "COATING" FROM THE PATIENT. SURGEON IDENTIFIED INSTRUMENT ERROR EARLY. THERE MAY BE DEFICIENCY IN THE DESIGN BUT MAY BE STRESS AND NUMBER OF TIMES USED. SURGEON PERFORMED EXTENSIVE I&D. INTRA-OP IMAGES ARE AVAILABLE OF THE PROSTHESIS TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7159739 ↗
• MalfunctionNov 21, 2017Break; Break

  SYNERGY STATES THAT THE GREEN COLOUR WAS LOOSE AND FELL APART BUT OUTSIDE THE PATIENT AND AFTER IT HAS BEEN USED.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7049863 ↗