HemiCAPOVO® 8H02-5046-WRecalls & reported problems
Arthrosurface Incorporated · Humeral Component, 50mm x 46mm, OVO · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M5288H025046W0), 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Autoimmune Disorder1
- Blurred Vision1
- Cramp(s) /Muscle Spasm(s)1
- Ear infection1
- Eye Infections1
- Eye Pain1
- Failure of Implant1
- Fibrosis1
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; Vertigo; Viral Infection; Visual Impairment
MAUDE report 20486295 ↗
Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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