HemiCAPWAVE® PX11-0218-WRecalls & reported problems
Arthrosurface Incorporated · Taper Post, 11mm Ø x 21.5mm LG, PFXL CE · Class 2 · Implant
Data updated Oct 16, 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 M528PX110218W0), received between Oct 11, 2024 and Oct 11, 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.
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 11, 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.
Patient problems: Insufficient Information
MAUDE report 20429411 ↗
Other Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer devices
- Scorpio 73-3910Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls4 reports
- Scorpio 73-3508Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls3 reports
- Arthrex® AR-503-TTTCArthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall15 reports
- Arthrex® AR-503-TTTFArthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Scorpio 73-3308Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Arthrex® AR-504-PSC9Arthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- RESTORIS 160405Mako Surgical Corp. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- Arthrex® AR-504-PSD0Arthrex, Inc. · PROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER7 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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