UniCAP® US11-0205-WRecalls & reported problems
Arthrosurface Incorporated · Taper Post, 10.6mm UNI Small · Class 2 · Implant
- 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 M528US110205W0), 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information1
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 18 SEPT 2024 ARTHROSURFACE RECEIVED AN UNSOLICITED INQUIRY BY A HCP REQUESTING A REPRESENTATIVE CONTACT THE CLINIC REGARDING EXPLANTING A ARTHROSURFACE HEMICAP ARTHROPLASTY SYSTEM. THE HCP STATED THAT THE PATIENT'S (UNKNOWN AGE AND DEMOGRAPHIC) DISEASE (UNSPECIFIED) HAS PROGRESSED AND WILL BE REVISED WITH A TOTAL KNEE IMPLANT, (MANUFACTURER / TYPE UNKNOWN). THE HCP STATED THAT THERE WAS NO APPARENT DEFECT WITH THE ARTHROSURFACE IMPLANT. THE ORIGINAL IMPLANT DATE IS UNKNOWN. THE REVISION PROCEDURE DATE IS UNKNOWN. THE PART NUMBERS AND LOT NUMBERS OF THE INITIAL IMPLANT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN SOLICITED. THIS IS ONE OF THREE SUBMISSIONS FOR THE SAME EVENT.
Patient problems: Insufficient Information
MAUDE report 20484989 ↗
Other Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer devices
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- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.