VANGUARD COMPLETE KNEE SYSTEM 195757Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304552807), received between Jul 14, 2021 and Jan 22, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (1 report).

22 other recalls cover devices cleared under the same FDA submission (K132873); 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 16, 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.

• MalfunctionJan 22, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE LOCKING BAR WOULD NOT SUCCESSFULLY MATE WITH THE TIBIAL INSERT. THE PROCEDURE WAS COMPLETED USING ANOTHER TIBIAL INSERT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552388 ↗
• InjuryJul 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion; Pain; Swelling/ Edema

  MAUDE report 12165387 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132873. One submission often covers many models, so check the product and lot details in each record.

• Z-2507-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 69mm Item # 195272
• Z-2514-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 91 mm Item # 195279
• Z-2522-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 71 mm Item # 195755
• Z-2526-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 63 mm Item # 195751
• Z-2517-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 87 mm Item # 195760
• Z-2524-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 67 mm Item # 195753
• Z-2525-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 65 mm Item # 195752
• Z-2513-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 87 mm Item # 195278
• Z-2509-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 73mm Item # 195274
• Z-2504-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 63mm Item # 195269
• Z-2519-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 79 mm Item # 195758
• Z-2523-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 69 mm Item # 195754
• Z-2511-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 79 mm Item # 195276
• Z-2520-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 75 mm Item # 195757
• Z-2521-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 73 mm Item # 195756

…and 7 more.