Series II 3052-0508Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327034011), received between Jul 19, 2018 and Jul 19, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K884398); 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.

• InjuryJul 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO PAIN, INSTABILITY, AND WEAR OF THE INSERT. THE INSERT WAS REVISED TO THE SAME CATALOG NUMBER, THE PATELLA WAS REVISED TO AN ASYMMETRIC PATELLA.

  Patient problems: Injury; Pain

  MAUDE report 7704137 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K884398. One submission often covers many models, so check the product and lot details in each record.

• Z-0874-2024 · Dec 1, 2023 · Open, Classified
  SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0524
• Z-0873-2024 · Dec 1, 2023 · Open, Classified
  SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515