Triathlon 5620-B-402Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327015553), received between Jan 31, 2018 and Mar 6, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K071881, K082567, K203099); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2023Migration; Migration

  RIGHT MEDIAL PKR. THE ORIGINAL SURGERY WAS ON (B)(6) 2015. AT A RECENT OFFICE VISIT, PER THE SUBJECT'S OFFICE NOTE "X-RAYS REVEAL SOME SUBSIDENCE OF THE TIBIAL COMPONENT ANTERIORLY." SUBJECT HAS PAIN OCCASIONALLY ON STAIRS GLOBALLY AROUND HIS KNEE. SUBJECT HAS SOME PROGRESSION OF ARTHRITIC CHANGES IN LATERAL AND PATELLOFEMORAL COMPARTMENTS AS WELL. HIS SYMPTOMS ARE MOST LIKELY MORE RELATED TO PROGRESSIVE ARTHRITIC CHANGES. DR. NOTED IT WAS UNCLEAR IF THIS IS RELATED TO HIS RIGHT QUADRICEP TENDON INJURY ON (B)(6) 2022 WHEN HE WAS SENT TUMBLING BY A WAVE IN THE OCEAN. THE TENDON RUPTURED DURING THIS EVENT. THE TENDON REPAIR SURGERY TOOK PLACE ON (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 16492408 ↗
• InjuryMay 11, 2020Fracture; Fracture

  AFTER THE OPERATION, IT WAS CONFIRMED THAT THE INNER CONDYLE OF THE TIBIA WAS FRACTURED. OSTEOSYNTHESIS IS SCHEDULED FOR (B)(6).

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10043745 ↗
• InjuryJan 31, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED AND STATED THAT SHE HAD A RIGHT KNEE IMPLANT ON (B)(6) 2016. SHE STATED THAT SHE EXPERIENCED COMPLICATIONS, PAIN AND SWELLING RIGHT FROM THE START AND IT NEVER WENT AWAY. THE PATIENT HAD A REVISION ON (B)(6) 2017. THE PATIENT'S REVISION DOCTOR SAID THAT WHEN HE WENT IN, THE IMPLANT WAS "DANGLING".

  Patient problems: Injury; Pain; Swelling

  MAUDE report 7231704 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071881, K082567, K203099. One submission often covers many models, so check the product and lot details in each record.

• Z-0869-2009 · Nov 25, 2008 · Terminated
  Triathlon PKR Insert X3 #1 LM/RL - 8mm, 5630-G-108, Lot code NXDMEE Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122, Lot Code M8JMEE Intended Use: - Moderately disabling