Triathlon 5552-L-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327013542), received between Apr 20, 2022 and Oct 29, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Unstable” (2 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2025Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED. PATIENT PRESENTED WITH COMPLAINT OF PAIN AND A SUPERFICIAL WOUND INFECTION AND REPORTED A PRIOR FALL AND A BUG BITE. UPON OPENING THE JOINT, METAL-STAINED TISSUE WAS OBSERVED, AS WELL AS POSTERIOR LATERAL WEAR OF THE INSERT TO THE POINT WHERE THE FEMORAL COMPONENT WAS ARTICULATING AGAINST THE BASEPLATE. SURGEON SUSPECTED THE FALL MAY HAVE DISRUPTED THE SOFT TISSUES OR SHIFTED THE IMPLANTS, CAUSING THE UNEVEN WEAR. THOUGH NO LAB RESULTS CAME BACK TO INDICATE WHETHER THE JOINT WAS INFECTED OR NOT, ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED AS A PRECAUTIONARY MEASURE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall; Metal Related Pathology; Pain; Unspecified Infection

  MAUDE report 23417582 ↗
• InjurySep 22, 2025Fracture; Fracture

  ADDITIONAL INFO. 18-SEPT-2025: PT CALLED AND REPORTED; THEY JUST HAD TO HAVE A REVISION FOR THEIR KNEE REPLACEMENT OF A STRYKER PART. THE PATELLA COMPONENT HAD TO BE REPLACED IT WAS DEFECTIVE AND THEY HAD THE REVISION SURGERY ON (B)(6) 2025 AND THEIR ORIGINAL KNEE SURGERY OR KNEE REPLACEMENT WAS ON (B)(6) 2024

  Patient problems: Pain

  MAUDE report 23118597 ↗
• InjuryMar 1, 2024Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO GLOBAL INSTABILITY AND PAIN. INTRA-OPERATIVELY, THE FOLLOWING WERE OBSERVED: THE LOCKING WIRE OF THE INSERT BROKE, AND THE INSERT DISLODGED FROM THE BASEPLATE. THE FEMORAL COMPONENT WAS ARTICULATING POSTERIORLY, CAUSING INSERT WEAR AND METALLOSIS DUE TO ARTICULATING WITH THE BASEPLATE. THE BASEPLATE'S POSTERIOR MEDIAL PORTION WAS BROKEN OFF. PATIENT'S ACTIVITY LEVEL WAS NORMAL, NO TRAUMA REPORTED. THE PATIENT'S CR KNEE (INCLUDING PATELLAR COMPONENT) WAS CONVERTED TO A TS KNEE. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 18814722 ↗
• InjuryApr 20, 2022Unstable; Unstable

  5 YEAR FOLLOW-UP OF TRIATHLON TRITANIUM OUTCOMES STUDY, PATIENT REPORTED DISSATISFACTION WITH THEIR KNEE REPLACEMENT. ADDITIONAL COMMENTS: "ALWAYS PUTTING LIDOCAINE ON EVERY NIGHT TO GET TO SLEEP. NOT MUCH PAIN. HAVE FALLEN NUMEROUS TIMES. ALWAYS NERVOUS WALKING. KNEE STILL GIVES OUT, JUST FEELS TOO LOOSE."

  Patient problems: Pain

  MAUDE report 14161914 ↗