ANTHEM 71422675Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556583883), received between Apr 23, 2021 and Mar 8, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K032295, K230653); 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.

• InjuryMar 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2026, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH ONE (1) ANTHEM PS HF INSERT SZ 5-6 11MM WAS EXPLANTED AND REPLACED WITH ONE (1) GII PS INSERT SZ 5-6 11MM.

  Patient problems: Unspecified Infection

  MAUDE report 24542205 ↗
• MalfunctionApr 23, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A TKA, THE CONNECTION OF A ANTHEM PS HF INSERT SZ 5-6 11MM FAILED WHILE INSIDE THE PATIENT. IT WAS REPORTED THAT THIS WAS AN OUT OF THE BOX FAILURE. THERE WAS DELAY OF 30 MINUTES OR LESS AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716294 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032295, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-0448-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0446-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0447-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0445-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0444-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0449-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic