Arthrex® AR-513-BH10Recalls & reported problems
Arthrex, Inc. · IBAL TKA,BEARING IMP,PS,SZ 7,10MM · Class 2
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 00888867107557), received between May 18, 2021 and May 18, 2021 — 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.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
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.
InjuryMay 18, 2021Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED BY THE PATIENT¿S LEGAL REPRESENTATIVE THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE PROCEDURE ON (B)(6) 2014, AND IS EXPERIENCING UNKNOWN ISSUES WITH THE KNEE REPLACEMENT. THE FOLLOWING ARTHREX PRODUCT WAS IMPLANTED DURING THE PRIMARY PROCEDURE: AR-503-TTTH (LOT: 780842), AR-516-7R (LOT: 108761412) X 2, AR-513-BH10 (LOT: 113601339), AR-504-PSD0 (LOT: 113601323). TO DATE NO REVISION HAS BEEN REPORTED. THE PATIENT ALSO HAD A LEFT TOTAL KNEE PROCEDURE ON (B)(6) 2014 WHICH WAS REVISED ON (B)(6) 2019 (SEE CASE (B)(4)). ADDITIONAL INFORMATION RECEIVED ON 4/26/2021: ARTHREX HAS RECEIVED CONFIRMATION THAT THE PATIENT'S RIGHT KNEE WAS REVISED ON (B)(6) 2021. NO ADDITIONAL DETAILS PERTAINING TO THE REVISION SURGERY HAVE BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 11841724 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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