TRIATHLON 5612-P-611Recalls & reported problems
Howmedica Osteonics Corp. · Hinge Insert · Class 2 · Implant
All models of Triathlon (608)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327601954), received between Feb 25, 2026 and Aug 25, 2026 — classified as 3 injuries.
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
- Adverse Event Without Identified Device or Use Problem3
Patient problems
- Unspecified Infection3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
The patient had Right TKA Out of CORS Scope. The patient developed PJI and was revised (All components) on (b)(6) 2024 (Is then included in CORS) The patient received a Triathlon Revision System. The patient developed again PJI and is revised on (b)(6), 2025. Only the Poly and Rotating Hinge Components were Exchanged.
Patient problems: Unspecified Infection
MAUDE report 50422113 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: REVISED A RIGHT KNEE DISTAL FEMORAL REPLACEMENT DUE TO INFECTION. REVISED TO A SPACER USING TWO RETROGRADE NAILS AND A PLATE.
Patient problems: Unspecified Infection
MAUDE report 25147110 ↗InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem
THE FOLLOWING INFORMATION WAS PROVIDED: SURGEON PERFORMED A RIGHT KNEE I&D OF A DISTAL FEMORAL REPLACEMENT DUE TO INFECTION. HE SWAPPED ALL MODULAR PARTS.
Patient problems: Unspecified Infection
MAUDE report 24443461 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER devices
- ELEOS™ 25001208EOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER3 deaths193 reports
- ELEOS™ THSMWRS01MOnkos Surgical, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER190 reports
- "UNITED" USTAR II Hip System 1115-1413United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls3 reports
- "UNITED" USTAR II Hip System 1115-1213United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1417United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- "UNITED" USTAR II Hip System 1115-1217United Orthopedic Corp. · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer3 recalls0 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/12WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 reports
- Endo-Model Modular Knee Prosthesis System 15-3816/11WALDEMAR LINK GmbH & Co. KG · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer2 recalls6 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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