Triathlon 5550-L-339Recalls & reported problems
Howmedica Osteonics Corp. · Patella · Class 2 · Implant
All models of Triathlon (608)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327050226), received between May 1, 2019 and Aug 4, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Osseointegration Problem” (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
- Osseointegration Problem1
- Unstable1
Patient problems
- Inadequate Osseointegration1
- Injury1
- Joint Laxity1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2021Unstable; Unstable
AS REPORTED: "THE (RIGHT KNEE) REVISION WAS PERFORMED DUE TO FLEXION INSTABILITY. THERE IS NO FURTHER INFORMATION AVAILABLE." SPOKE TO REP, WHO PROVIDED THE PRIMARY MAKO AND REVISION USAGE SHEETS. THERE ARE NO ALLEGATIONS AGAINST ANY OF THE BONE CUTS OR IMPLANT POSITIONING. A CR FEMUR, CS INSERT, AND CEMENTED PATELLA WERE REVISED TO A PS FEMUR WITH AUGMENTS, A TS INSERT, AND ANOTHER CEMENTED PATELLA. REP RE-CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Joint Laxity
MAUDE report 12273817 ↗InjuryMay 1, 2019Osseointegration Problem; Osseointegration Problem
POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT (B)(6) 2012. IMAGING REVEALED GROSSLY LOOSE PATELLA PROSTHESIS. PATIENT UNDERWENT KNEE REVISION, THE LINER WAS ALSO REMOVED (B)(6) 2018.
Patient problems: Inadequate Osseointegration; Injury
MAUDE report 8568516 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- 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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