Triathlon 5521-B-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327026306), received between Jun 11, 2019 and Oct 29, 2024 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Osseointegration Problem” (5 reports).

1 FDA recall record name this device's identifier, 1 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, 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.

Recalls naming this device

1. Sep 4, 2024Class IIOpen, 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 ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 29, 2024Loss of Osseointegration; Loss of Osseointegration

  A TRIATHLON TS KNEE WITH STEMS AND AUGMENTS WAS IMPLANTED ON (B)(6)2020. AS OF (B)(6)2021, THE FOLLOWING WERE NOTED: "PATIENT FELL IN (B)(6) (2021) AND SUBSEQUENTLY INJURED HER KNEE AND WILL NEED HER PATELLAR REVISED IN THE FUTURE." IN (B)(6) 2021, PATELLAR LOOSENING WAS CITED. ON (B)(6)2021, LOOSENING OF THE TIBIA WAS ALSO NOTED. AS OF (B)(6)2021, THE PATIENT HAS NOT BEEN REVISED DUE TO PATIENT FACTORS.

  Patient problems: Fall; Inadequate Osseointegration; Pain

  MAUDE report 20559719 ↗
• MalfunctionJun 27, 2024Product Quality Problem; Product Quality Problem

  CS POLY (2X10) WOULD NOT PROPERLY LOCK INTO THE UNIVERSAL BASEPLATE. USED A DIFFERENT BASEPLATE AND LONG STEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625581 ↗
• MalfunctionJun 27, 2024Product Quality Problem; Product Quality Problem

  TRIATHLON UNIVERSAL BASEPLATE WAS IMPLANTED INTO THE TIBIA. CORRECT SIZE POLY WAS ATTEMPTED TO IMPLANT WITHOUT SUCCESS. SECOND POLY WAS OPENED AND FAILED AGAIN. IT WAS NOTICED THAT THE ANTERIOR LOCKING TEETH OF THE BASEPLATE SEEMED TO BE TOO LONG AND NOT IN SPECS. BASEPLATE WAS REMOVED AND A NEW BASEPLATE OF THE SAME SIZE WAS IMPLANTED. CEMENT HAD TO BE REMOVED FROM TIBIA DELAYING TO CASE. SECOND BATCH OF CEMENT HAD TO BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19625572 ↗
• MalfunctionDec 21, 2023Device Difficult to Setup or Prepare; Product Quality Problem; Device Difficult to Setup or Prepare; Product Quality Problem

  AFTER IMPLANTING THE TIBIAL BASEPLATE WITH CEMENT BEING SET BY OVER 20 MINUTES, SURGEON TRIED TO IMPACT THE INSERT ONTO THE BASEPLATE. WHILE IT FAILED TO SEAT ON THE BASEPLATE COMPLETELY AS THE LOCKING WIRE WAS PUSHED SUPERIORLY AT TWO POINTS ON THE SLOT. THEN ANOTHER INSERT WAS OPENED BUT THE SAME SITUATION OCCURRED. THEN THE SURGEON LOOKED AT THE TIBIAL BASEPLATE AND SUSPECTED THAT ITS THE DEFECT OF THE BASEPLATE CAUSING THE FAILURE INSTEAD OF THE INSERT ITSELF. HE OPENED ANOTHER BASEPLATE WITH ONE SIZE DOWN TO COMPARE IN ORDER TO INSPECT ANY DEFECTS. HE FOUND OUT THAT THE TWO BARBS OF THE USED BASEPLATE IS DIFFERENT FROM THE NEW ONE. THE BARBS IS NOT FLUSHED WITH AN ANGLE SO THAT IT CANNOT ALLOW THE WIRE OF INSERT TO BE SEATED ONTO BASEPLATE. THE SURGEON THEN DECIDED TO USE THE BUR WITH POWER TO WEAR OUT A LITTLE OF THE BARDS AND SUCCEEDED TO SEAT A NEW INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18378172 ↗
• InjuryMar 1, 2023Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "REVISION TODAY WAS SECONDARY TO PAIN AND APPEARANCE OF TIBIAL LOOSENING ON X-RAY. TIBIAL COMPONENT WAS OBSERVED TO BE LOOSE IN SURGERY." A BASEPLATE AND INSERT WERE REVISED TO ANOTHER INSERT AND BASEPLATE WITH STEM AND AUGMENTS. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED INSERT.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16458083 ↗
• InjuryMay 9, 2022Unstable; Unstable

  PATIENT CALLED AND IS INQUIRING ABOUT RECALL FOR HER RIGHT KNEE SURGERY ON (B)(6) 2016. UPDATE (B)(6) 2022: PATIENT IS EXPERIENCING INSTABILITY. SHE HAS SEEN THREE DIFFERENT SURGEONS AND HAS UPCOMING REVISION SURGERY IN MID JUNE. PATIENT WOULD LIKE TO KNOW WHAT IMPLANTS SHE CAN USE IN HER REVISION FOR A BETTER OUTCOME.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 14342923 ↗
• InjuryDec 19, 2019Osseointegration Problem; Osseointegration Problem

  THIS PI WAS CREATED BASED ON THE MEDICAL REVIEW PROVIDED FOR PI. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2011. DUE TO TIBIAL LOOSENING WHEREBY ALL TRIATHLON TS COMPONENTS EXCEPT THE PATELLA WERE REVISED TO COMPETITORS PRODUCTS.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9495183 ↗
• InjuryNov 15, 2019Osseointegration Problem; Osseointegration Problem

  MEDICAL RECORDS PROVIDED FOR LEGAL PI HAVE INDICATED ADDITIONAL TREATMENTS/REVISIONS THE PATIENT UNDERWENT. THIS PI IS FOR A SECOND REVISION SURGERY THE PATIENT UNDERWENT ON (B)(6) 2017 DUE TO BASEPLATE/TIBIAL STEM LOOSENING. EXCERPT FROM MEDICAL REVIEW: "LOOSENING OF THE TRIATHLON BASEPLATE WITH ASSOCIATED STEM EXTENDER WAS CONFIRMED WHILE FEMORAL AND PATELLAR COMPONENTS PROVED TO BE WELL FIXED AND WERE AS SUCH RETAINED."... ¿THE USE OF A RELATIVELY SHORT 50-MM STEM EXTENDER BELOW AN AUGMENT IN A PROXIMAL TIBIAL BONE DEFECT CONDITION DID NOT PROVIDE ADEQUATE STABILITY TO THE NEWLY IMPLANTED BASEPLATE DURING THE PREVIOUS REVISION WITH EXCESSIVE MICROMOTION IN THE IMPLANT-BONE INTERFACE RESULTING IN EARLY LOOSENING REQUIRING A SECOND REVISION WITHIN SHORT INTERVAL. "...

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9329146 ↗
• InjuryNov 15, 2019Loss of Osseointegration; Osseointegration Problem; Insufficient Device Problem Information; Loss of Osseointegration; Osseointegration Problem; Insufficient Device Problem Information

  MEDICAL RECORDS PROVIDED HAVE INDICATED ADDITIONAL TREATMENTS/REVISIONS THE PATIENT UNDERWENT. THIS PI IS FOR A THIRD REVISION SURGERY THE PATIENT UNDERWENT ON (B)(6) 2018 DUE TO LOOSENING ON TIBIAL SIDE (BASEPLATE/TIBIAL STEM/AUGMENT) LOOSENING. AN INTRAOPERATIVE FRACTURE OF THE TIBIA WAS ALSO REPORTED TO HAVE OCCURRED DURING THIS REVISION SURGERY ON (B)(6) 2019. EXCERPT FROM MEDICAL REVIEW: "EARLY LOOSENING OF BASEPLATE WITH STEM EXTENDER AND AUGMENT OCCURRED REQUIRING A THIRD REVISION SURGERY." "REMOVING ALL BONE CEMENT FROM THE TIBIAL CANAL WAS AGAIN DIFFICULT AND REQUIRED MAKING A WINDOW IN THE TIBIAL CORTICAL BONE FOR DISTAL ACCESS TO THE BONE CEMENT FOR REMOVAL. LATERAL AND POSTERIOR ¿CRACKS¿ DEVELOPED IN THE TIBIAL CORTEX DURING THESE DIFFICULT MANOEUVRES TO REMOVE ALL BONE CEMENT."

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Injury

  MAUDE report 9329141 ↗
• InjuryJun 11, 2019Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THROUGH THE COMMUNICATION OF AN ATTORNEY THAT ALLEGEDLY THE PATIENT WAS REVISED DUE TO "MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHESIS".

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8687201 ↗