VANGUARD COMPLETE KNEE SYSTEM 195753Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00880304553132), received between Oct 30, 2020 and Feb 10, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 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 10, 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: Cyst(s); Failure of Implant

  MAUDE report 11307028 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY TWO AND A HALF YEARS POST-IMPLANTATION TO ADDRESS PAIN, SWELLING, AMBULATION DIFFICULTIES, INSTABILITY AND LOOSENING OF THE TIBIAL TRAY. INITIAL OPERATIVE NOTES DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTE THE PATIENT WAS REVISED DUE TO PAIN AND ASEPTIC LOOSENING WITH NO INTRAOPERATIVE COMPLICATIONS WERE IDENTIFIED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 10763911 ↗

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-2510-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 75mm Item # 195275
• Z-2511-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 79 mm Item # 195276
• Z-2504-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 63mm Item # 195269
• Z-2518-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 83 mm Item # 195759
• Z-2520-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 75 mm Item # 195757
• Z-2512-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 83 mm Item # 195277
• Z-2517-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 87 mm Item # 195760
• Z-2522-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 71 mm Item # 195755
• Z-2521-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 73 mm Item # 195756
• Z-2508-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 71mm Item # 195273
• Z-2513-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 87 mm Item # 195278
• Z-2523-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 69 mm Item # 195754
• Z-2507-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 69mm Item # 195272
• Z-2525-2019 · Aug 15, 2019 · Terminated
  XP-XP Tibial Tray - Interlok 65 mm Item # 195752
• Z-2505-2019 · Aug 15, 2019 · Terminated
  XP-CR Tibial Tray - Interlok 65mm Item # 195270

…and 7 more.