GLOBAL 1136-42-025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295006985), received between Oct 10, 2017 and Oct 15, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Naturally Worn” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2021Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ADVERSE CONSEQUENCES WERE THAT PATIENT NEEDED REVISION TO REVERSE TOTAL SHOULDER DUE TO POLY WEAR ON THE GLENOID COMPONENT. NO DELAY OR EXTENDED SURGERY TIME. THIS WAS NOT A NATURAL PROGRESSION. THE LOT NUMBER OF GLENOID WAS ILLEGIBLE DUE TO POLY WEAR.

  Patient problems: Insufficient Information

  MAUDE report 12638518 ↗
• InjuryJan 28, 2021Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS WEAR AND LOOSENING OF THE GLENOID COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2007, DOR: (B)(6) 2021, RIGHT SHOULDER.

  Patient problems: Insufficient Information

  MAUDE report 11244426 ↗
• InjuryDec 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED IN CLINIC WITH PAINFUL RIGHT SHOULDER SURGEON HAD REPLACED IN (B)(6) 2003 AT (B)(6) HOSPITAL. PATIENT ALSO EXHIBITED LOSS OF FUNCTION IN RIGHT SHOULDER SO THE DOCTOR ELECTED TO PERFORM A REVISION SURGERY ON PATIENT¿S RIGHT SHOULDER. PERFORMED REVISION SURGERY ON (B)(6) 2019 AT (B)(6) HOSPITAL. SURGEON REMOVED THE GLENOID, HUMERAL STEM, AND HUMERAL HEAD WITH INSTRUMENTATION. HE THEN ELECTED TO IMPLANT A REVERSE SHOULDER PROSTHESIS USING COMPETITIVE SYSTEMS.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9519697 ↗
• InjuryNov 30, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISED DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 8119480 ↗
• InjuryOct 10, 2017Loss of Osseointegration; Loss of Osseointegration

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE GLENOID AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: No Information

  MAUDE report 6935359 ↗