Triathlon 5630-G-529Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327015676), received between Apr 21, 2026 and Apr 21, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Degraded” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Degraded

  THE FOLLOWING INFORMATION WAS PROVIDED: THE CUSTOMER REPORTED THAT DATE OF THE EVENT: 12/24/2025. LOCATION OF THE EVENT: BLOOD DISORDERS. REASON: DURING FOLLOW-UP AFTER INGUINAL HERNIA REPAIR, THE FOLLOWING WAS OBSERVED: "RESORPTIVE GRANULOMATOUS INFLAMMATION ON PROSTHETIC PARTICLES WITH A MORPHOLOGY CONSISTENT WITH POLYETHYLENE DEBRIS." THE RIGHT KNEE PROSTHESIS WAS IMPLANTED ON (B)(6) 2015. PROVEN CONSEQUENCES: RESORPTIVE GRANULOMATOUS INFLAMMATION ON PROSTHETIC PARTICLES WITH A MORPHOLOGY CONSISTENT WITH POLYETHYLENE DEBRIS? HAVE YOU RECORDED SIMILAR INCIDENTS INVOLVING THIS LOT OR THIS PRODUCT REFERENCE? THE RIGHT KNEE PARTIAL PROSTHESIS REMAINS IN THE PATIENT TO THIS DAY.

  Patient problems: Inflammation; Insufficient Information

  MAUDE report 24937571 ↗

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