Arthrex® AR-513-BG13Recalls & reported problems
Arthrex, Inc. · IBAL TKA,BEARING IMP,PS,SZ 6,13MM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867107489), received between Jun 6, 2025 and Jun 6, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).
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
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 6, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
ON 5/13/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT A PATIENT WHO UNDERWENT AN IBALANCE PROCEDURE HAS EXPERIENCED LOOSE IMPLANTS POST-SURGERY. DURING THE INITIAL SURGERY, AN AR-516-4R IBALANCE CEMENTED TKA FEMORAL IMPLANT PS, AN AR-503-TTTG IBALANCE CEMENTED TKA TIBIAL TRAY IMPLANT, AN AR-504-PSC9 IBALANCE DOMETKA PATELLA IMPLANT, AND AN AR-513-BG13 IBALANCE PS TKA TIBIAL BEARING IMPLANT WERE USED. ADDITIONAL INFORMATION WAS RECEIVED ON 5/21/2025: THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2015 AND THE PATIENT LOOSE IMPLANTS WERE NOTICED AROUND (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 5/22/2025: A REVISION SURGERY HAS NOT OCCURRED. THE PATIENT IS DOING WELL; HOWEVER, WANTS THE ISSUE RESOLVED.
Patient problems: Failure of Implant
MAUDE report 22161038 ↗
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
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Arthrex® AR-503-TTTGArthrex, 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 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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