Arthrex® AR-513-BG11Recalls & reported problems
Arthrex, Inc. · IBAL TKA,BEARING IMP,PS,SZ 6,11MM · 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 00888867107465), received between Nov 4, 2019 and Nov 4, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.
Most reported problems
Device problems
- Loose or Intermittent Connection1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2019Loose or Intermittent Connection
IT WAS REPORTED THAT ON (B)(6) 2015 THE PATIENT HAD UNDERGONE A BI-LATERAL TKA PROCEDURE. ON (B)(6) 2019 THE PATIENT UNDERWENT A REVISION RIGHT TKA PROCEDURE DUE TO PAIN AND TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE FOLLOWING ORIGINAL ARTHREX IMPLANT DEVICES WERE EXPLANTED: AR-503-TTTG, TIBIAL TRAY IMPLANT (LOT 108761215), AR-516-7R, FEMORAL IMPLANT (LOT 108761338), AR-513-BG11, TIBIAL BEARING IMPLANT (LOT 113601405), AR-504-PSC9, PATELLA IMPLANT (LOT 113601430). THE REVISION PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER MANUFACTURER'S DEVICES.
Patient problems: Pain
MAUDE report 9272305 ↗
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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