HemiCAPGRS® G203-2015-ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M528G2032015A0), received between Oct 18, 2024 and Oct 18, 2024 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ARTHROSURFACE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, ARTHROSURFACE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO A POTENTIAL PATIENT EVENT DOCUMENTED ON THIS REPORT. ON 26 SEPTEMBER 2024 ANIKA RECEIVED AN UNSOLICITED INQUIRY REGARDING THE OVO® INLAY SHOULDER ARTHROPLASTY SYSTEM. THE PATIENT REPORTED THAT THE IMPLANT ATE THROUGH THE PATIENT'S BONE AND MIGRATED CLEAR THROUGH THE PLASTIC AND ALL THE PATIENT'S SOFT TISSUE (LABRUM, ROTATOR CUFF, ETC..) AND IS NEAR THE CHEST WALL. THERE WAS NO SPECIFIC REPORT OF A PRODUCT DEFECT. THE PATIENT REPORTED THAT THE CLINIC WHO PERFORMED THE INITIAL IMPLANT IS NOW DEFUNCT. THE ORIGINAL IMPLANT DATE WAS ON OR ABOUT (B)(6) 2018. THE REVISION IS REPORTEDLY SCHEDULED FOR (B)(6) 2024. ADDITIONAL INFORMATION WAS SOLICITED. THIS IS ONE REPORT OF THREE FOR THE SAME EVENT. SUPPLEMENTAL REPORT: ON 21 OCTOBER 2024 ANIKA RECEIVED A MEDWATCH FROM THE FDA ON 21OCTOBER2024. PATIENT SUBMITTED (MW5159821) ON 17SEPT2024. THE MEDWATCH IS RELATED TO THIS COMPLAINT. THE PATIENT ALLEGES THAT THE ATTRIBUTED MET

  Patient problems: Autoimmune Disorder; Blurred Vision; Cramp(s) /Muscle Spasm(s); Ear infection; Eye Infections; Eye Pain; Failure of Implant; Fibrosis; Hearing Impairment; Inflammation; Joint Impingement; Loss of Range of Motion; Metal Related Pathology; Pain; Shaking/Tremors; Tinnitus; Unspecified Nervous System Problem; Urticaria; Vertigo; Viral Infection; Visual Impairment

  MAUDE report 20486099 ↗