Arthrex® AR-513-BE13Recalls & reported problems
Arthrex, Inc. · IBAL TKA,BEARING IMP,PS,SZ 4,13MM · Class 2
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 00888867107281), received between Oct 27, 2017 and Oct 27, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Slipped” (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 16, 2026.
Most reported problems
Device problems
- Device Slipped1
- Fracture1
- Unstable1
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.
InjuryOct 27, 2017Fracture; Device Slipped; Unstable
ON (B)(6) 2017 IT WAS REPORTED VIA THE PATIENT'S ATTORNEY THAT A PATIENT HAD UNDERGONE A REVISION TKA PROCEDURE. IT WAS REPORTED THAT PATIENT'S FIRST ISSUES WITH THE EXPLANTED DEVICE WERE INSTABILITY, PAIN AND MOTION WHICH AROSE IN (B)(6) 2015. AT THE TIME OF INITIAL REPORT THE FOLLOWING ARTHREX PRODUCT WAS INDICATED: AR-503-TTTE, LOT 1206173. NEITHER THE ORIGINAL SURGERY DATE OR REVISION SURGERY DATE WERE PROVIDED DURING INITIAL REPORT. PATIENT DATE OF BIRTH IS (B)(6). ADDITIONAL INFORMATION RECEIVED ON 10/02/2017: ON (B)(6) 2014 PATIENT UNDERWENT A BILATERAL TKA PROCEDURE. PATIENT HAS EXPERIENCED CONSTANT PAIN SINCE ORIGINAL SURGERY. ON (B)(6) 2016 EXAM AND RADIOGRAPHS WERE PERFORMED. ON (B)(6) 2016 SURGEON PERFORMED A REVISION RIGHT TKA DUE TO PAIN AND TIBIAL LOOSENING. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE IBALANCE TKA TIBIAL TRAY, AR-503-TTTE, LOT 1206173 (LINE 206787); IBALANCE PATELLA IMPLANT DOME, AR-504-PSC9, LOT 113601411 (LINE 209438); IBALANCE TKA BEARING, AR-513-BE13, LOT 113601345 (LINE 209440); AND IBALANCE TKA FEMORAL IMPLANT, AR-516-4R, LOT 108761406 (LINE 209441). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT
Patient problems: Pain
MAUDE report 6983256 ↗
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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