TriathlonRecalls & reported problems across all models
Howmedica Osteonics Corp. · 608 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
15 open recalls name at least one Triathlon model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3,524
- Deaths reported
- 2
- Injuries reported
- 3,223
- Recalls
- 15
We found 608 models of Triathlon by Howmedica Osteonics Corp. in the FDA's device registry (GUDID). Together they are named in 3,524 adverse event reports in the FDA's MAUDE database, received between Jan 4, 2017 and Sep 25, 2026 — classified as 2 deaths, 3,223 injuries, 299 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (819 reports).
15 FDA recall records name at least one of these models by its device identifier, 15 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Triathlon recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 30, 2026Open, Classified
Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
Z-3198-2026 · Root cause: Process change control · names 2 of these models · Recall details · FDA record ↗
- May 19, 2026Open, Classified
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
Z-2462-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- May 19, 2026Open, Classified
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
Z-2461-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 4, 2024Open, Classified
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
Z-0023-2025 · Root cause: Process control · Recall details · FDA record ↗
- Feb 6, 2024Open, Classified
Potential packaging breaches of inner blister and outer sterile blister.
Z-1266-2024 · Root cause: Packaging · Recall details · FDA record ↗
- Feb 6, 2024Open, Classified
Potential packaging breaches of inner blister and outer sterile blister.
Z-1265-2024 · Root cause: Packaging · Recall details · FDA record ↗
- Feb 6, 2024Open, Classified
Potential packaging breaches of inner blister and outer sterile blister.
Z-1264-2024 · Root cause: Packaging · Recall details · FDA record ↗
- Feb 6, 2024Open, Classified
Potential packaging breaches of inner blister and outer sterile blister.
Z-1263-2024 · Root cause: Packaging · Recall details · FDA record ↗
- Feb 6, 2024Open, Classified
Potential packaging breaches of inner blister and outer sterile blister.
Z-1262-2024 · Root cause: Packaging · Recall details · FDA record ↗
- Feb 6, 2024Open, Classified
Potential packaging breaches of inner blister and outer sterile blister.
Z-1261-2024 · Root cause: Packaging · Recall details · FDA record ↗
- Feb 6, 2024Open, Classified
Potential packaging breaches of inner blister and outer sterile blister.
Z-1260-2024 · Root cause: Packaging · Recall details · FDA record ↗
- Feb 6, 2024Open, Classified
Potential packaging breaches of inner blister and outer sterile blister.
Z-1259-2024 · Root cause: Packaging · Recall details · FDA record ↗
- Apr 13, 2023Open, Classified
Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
Z-1654-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Apr 13, 2023Open, Classified
Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
Z-1653-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 30, 2022Open, Classified
Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.
Z-1237-2022 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
Most reported Triathlon problems
Device problems
- Adverse Event Without Identified Device or Use Problem849
- Insufficient Device Problem Information819
- Unstable665
- Loss of Osseointegration291
- Fracture182
- Osseointegration Problem164
- Degraded104
- Malposition of Device92
Patient problems
- Injury1,300
- Pain749
- Unspecified Infection693
- Inadequate Osseointegration441
- Joint Laxity359
- Ambulation or Postural Difficulties304
- Insufficient Information265
- Loss of Range of Motion183
Triathlon models
608 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Triathlon 5521-B-400PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall28 reports
- Triathlon 5536-B-600PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall28 reports
- Triathlon 5536-B-500PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall21 reports
- Triathlon 5521-B-300PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-610-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 reports
- Triathlon 5531-G-611-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall15 reports
- Triathlon 5521-B-200PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall10 reports
- Triathlon 5520-B-400PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER58 reports
- Triathlon 5531-G-310-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall6 reports
- Triathlon 5537-G-411-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall5 reports
- Triathlon 5537-G-416-EPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall5 reports
- Triathlon 5537-G-513-EPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall5 reports
- Triathlon 5532-G-413-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall4 reports
- TRIATHLON 5612-P-411PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- TRIATHLON 5612-P-413PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER1 recall1 report
- Triathlon 5537-G-311-EPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Triathlon 5531-G-312-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- Triathlon 5520-B-300PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER48 reports
- Triathlon 5536-B-300PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER47 reports
- Triathlon 5531-G-409PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER45 reports
- Triathlon 5531-G-509-EPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER44 reports
- Triathlon 5531-G-609PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER42 reports
- Triathlon 5531-G-609-EPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER42 reports
- Triathlon 5531-G-509PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER41 reports
- Triathlon 5531-G-309PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER40 reports
- Triathlon 5536-B-400PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER39 reports
- Triathlon 5532-G-509PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER38 reports
- Triathlon 5531-G-409-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER37 reports
- Triathlon 5510-F-502PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER36 reports
- Triathlon 5510-F-402PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER33 reports
- Triathlon 5531-G-309-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER33 reports
- Triathlon 5531-G-311PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER32 reports
- Triathlon 5530-G-409PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER32 reports
- Triathlon 5520-B-500PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER31 reports
- Triathlon 5532-G-609PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER31 reports
- Triathlon 5531-G-411PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER30 reports
- Triathlon 5510-F-302PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER29 reports
- Triathlon 5510-F-401PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER29 reports
- Triathlon 5520-B-200PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER28 reports
- Triathlon 5536-B-200PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER28 reports
- Triathlon 5532-G-409PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER27 reports
- Triathlon 5532-G-411PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER27 reports
- Triathlon 5551-G-320PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER25 reports
- Triathlon 5521-B-600PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER24 reports
- Triathlon 5530-G-411PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER24 reports
- Triathlon 5532-G-311PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER24 reports
- Triathlon 5532-G-309PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER23 reports
- Triathlon 5521-B-500PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER22 reports
- Triathlon 5517-F-402PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER22 reports
- Triathlon 5531-G-209PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER22 reports
- Triathlon 5531-G-511PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER22 reports
- Triathlon 5531-G-709PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER22 reports
- Triathlon 5532-G-709PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER22 reports
- Triathlon 5532-G-511PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER22 reports
- Triathlon 5520-B-600PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER21 reports
- Triathlon 5532-G-611PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER21 reports
- Triathlon 5510-F-501PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER20 reports
- Triathlon 5517-F-401PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER20 reports
- Triathlon 5510-F-301PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER19 reports
- Triathlon 5515-F-402PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER19 reports
- Triathlon 5530-G-309PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER19 reports
- Triathlon 5530-G-509PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER19 reports
- Triathlon 5515-F-502PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER18 reports
- Triathlon 5530-G-311PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER18 reports
- Triathlon 5532-G-513PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER18 reports
- Triathlon 5531-G-209-EPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER18 reports
- Triathlon 5531-G-410-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER17 reports
- Triathlon 5551-G-299PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER16 reports
- Triathlon 5517-F-501PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- Triathlon 5531-G-413PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER16 reports
- Triathlon 5531-G-613PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER16 reports
- Triathlon 5531-G-611PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER16 reports
- Triathlon 5551-G-350PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- Triathlon 5517-F-302PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- Triathlon 5531-G-513PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- Triathlon 5530-G-609PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER15 reports
- Triathlon 5517-F-301PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER14 reports
- Triathlon 5517-F-502PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- Triathlon 5532-G-413PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- Triathlon 5531-G-511-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER14 reports
- Triathlon 5531-G-313PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER13 reports
- Triathlon 5532-G-711PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- Triathlon 5554-L-350PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER13 reports
- Triathlon 5515-F-301PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER13 reports
- Triathlon 5515-F-501PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- Triathlon 5532-G-416PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- Triathlon 5532-G-309-EPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- Triathlon 5532-G-709-EPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER13 reports
- Triathlon 5532-G-409-EPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- Triathlon 5552-L-350PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER12 reports
- Triathlon 5517-F-601PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- Triathlon 5532-G-209PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER12 reports
- Triathlon 5530-G-413PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER12 reports
- Triathlon 5512-F-601PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER11 reports
- Triathlon 5515-F-401PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- Triathlon 5515-F-602PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER11 reports
- Triathlon 5530-G-511PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER11 reports
- Triathlon 5532-G-313PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- Triathlon 5531-G-311-EPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
Recent Triathlon adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem
The following information was provided: I&D with insert exchange of a right knee due to infection. He revised from a 2x16 to a 2x13 for better range of motion.
Patient problems: Unspecified Infection
MAUDE report 50896098 ↗InjurySep 24, 2026Mechanical Problem
The following information was provided: It was reported that the patient's Left knee was revised due to stiffness. A 5x11 Triathlon revision TS insert was revised to a 5x9 TS revision insert. Rep confirmed that no further information will be released by the hospital or surgeon.
Patient problems: Loss of Range of Motion
MAUDE report 50880739 ↗InjuryAug 31, 2026Fracture
After opening the right joint up for a revision, the patella implant was damaged. It had a big piece of poly missing. No particular reason why. It was removed and a cemented patella was used.
Patient problems: Insufficient Information
MAUDE report 50516659 ↗InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient's Right knee was revised due to infection. A CR/ CS knee was removed and a TS knee with stems and augment was implanted. Rep confirmed that no further information will be released by the hospital or surgeon.
Patient problems: Unspecified Infection
MAUDE report 50499707 ↗InjuryAug 27, 2026Unstable
Patient problems: Joint Laxity
MAUDE report 50465563 ↗InjuryAug 26, 2026Unstable
Left knee. Patient had their insert revised due to instability in both flexion and extension. A 4x9 CS insert was exchanged for a 4x11 CS insert. No other information available due to Hospital policy.
Patient problems: Joint Laxity
MAUDE report 50461231 ↗InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem
It was reported by the Sales rep that the patient underwent a MAKO Total Knee Replacement (TKR) on (b)(6) 2026 and was subsequently admitted on (b)(6) 2026 due to septic arthritis. According to the inpatient report, the condition was most likely due to a Streptococcal Prosthetic Joint Infection (PJI). A liner exchange procedure was performed on (b)(6) 2026 at 1250 hrs. The original Triathlon X3 Tibial Bearing Insert ¿ CR, Size 5, 10 mm was explanted and replaced with an identical Triathlon X3 Tibial Bearing Insert ¿ CR, Size 5, 10 mm with Lot: L66ATJ.
Patient problems: Bacterial Infection
MAUDE report 50460765 ↗InjuryAug 25, 2026No Apparent Adverse Event
Patient problems: Unspecified Infection
MAUDE report 50442445 ↗InjuryAug 25, 2026Loss of Osseointegration
Second revision TKA. Reason for revision: loosening. Outcome: all implants removed, TS femur implanted, universal baseplate implanted, TS insert implanted.
Patient problems: Inadequate Osseointegration
MAUDE report 50435587 ↗InjuryAug 25, 2026Loss of Osseointegration
Second revision TKA. Reason for revision: loosening. Outcome: all implants removed, TS femur implanted, universal baseplate implanted, TS insert implanted.
Patient problems: Inadequate Osseointegration
MAUDE report 50435586 ↗InjuryAug 25, 2026Loss of Osseointegration
Second revision TKA. Reason for revision: loosening. Outcome: all implants removed, TS femur implanted, universal baseplate implanted, TS insert implanted.
Patient problems: Inadequate Osseointegration
MAUDE report 50435584 ↗InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50422456 ↗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 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Loss of Range of Motion; Pain
MAUDE report 50419199 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50419196 ↗
Other Howmedica Osteonics Corp. products
- Scorpio107 models · 113 reports · 28 recalls
- Trident160 models · 1,280 reports · 2 recalls
- Accolade57 models · 1,228 reports
- Duracon58 models · 65 reports · 16 recalls
- LFIT23 models · 852 reports
- TRIDENT II42 models · 188 reports · 12 recalls
- INSTRUMENT131 models · 290 reports · 7 recalls
- EXETER36 models · 344 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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