Triathlon 5630-G-528Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327015669), received between Sep 10, 2024 and Feb 6, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED BY THE CUSTOMER THAT "REVISION FROM A UNI KNEE TO A TOTAL KNEE DUE TO WEAR ON THE UNI POLYETHYLENE AND PROGRESSION OF DISEASE, UPON SURGICAL APPROACH NOTICED THAT THE FEMORAL COMPONENT WAS BROKEN".

  Patient problems: Insufficient Information

  MAUDE report 21323336 ↗
• InjurySep 10, 2024Use of Device Problem; Use of Device Problem

  THE FOLLOWING WAS REPORTED: "PRIMARY PROCEDURE, RIGHT MEDIAL MAKO UNI. IT WAS REPORTED THAT A TRIATHLON PKR INSERT WAS IMPLANTED WITH A RESTORIS MCK FEMORAL COMPONENT AND BASEPLATE. INTRA-OPERATIVELY, THE INSERT HAD LOCKED INTO THE BASEPLATE. DISCOVERY WAS MADE POST-OP WHEN THE JR ASSOCIATE WAS TRYING TO ENTER THE CASE USAGE. THE PATIENT WAS REVISED THE NEXT DAY TO IMPLANT A RESTORIS MCK INSERT. JR ASSOCIATE CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20186311 ↗

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