GLOBAL ADVANTAGE 1128-44-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295005131), received between Jun 21, 2017 and Jun 13, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryJun 13, 2018Naturally Worn

  REVISION S-FIT AND GLOBAL ADVANTAGE SHOULDER REPLACEMENT, (B)(6) PRIVATE (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2004. S-FIT GLENOID USE WITH GLOBAL ADVANTAGE STEM FOR ANATOMICAL SHOULDER REPLACEMENT 14 YEARS AGO. PATIENT EXPERIENCED PAIN ONSET AND WAS ADVISED TO REVISE DUE TO ROTATOR CUFF DEFICIENCY. THERE WAS POLY WEAR AND GLENOID WEAR TO THE POINT WHERE THERE WAS METAL ON METAL WITH THE PROSTHESIS. REVISED ALL IMPLANTS, WITH DELTA XTEND REVERSE SHOULDER. RELEVANT PATIENT PRE-EXISTING CONDITIONS/ COMORBIDITIES: ROTATOR CUFF DEFICIENCY. PATIENT INITIAL (B)(6). UNKNOWN JRN: (B)(4) S-FIT GLENOID BEARING 44X3 LOT # 1141284; UNKNOWN JRN: (B)(4) S-FIT MB GLENOID 44MM LOT # YMV-40; UNKNOWN JRN: NO PRODUCT CODE - 3.5X28 SCREWS FOR S-FIT - LOT # UNKNOWN.

  Patient problems: Not Applicable; Pain

  MAUDE report 7596620 ↗
• InjuryJun 21, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE PATIENT WAS REVISED TO ADDRESS OVERSTUFFED IN THE JOINT.

  Patient problems: Loss of Range of Motion

  MAUDE report 6657680 ↗