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Anthem 71422977Recalls & reported problems

Smith & Nephew, Inc. · ANTHEM CRUCIATE RETAINING HI-FLEX INSERT SIZE 7-8 9MM · Class 2 · Implant

All models of ANTHEM (25)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556656112), received between Nov 3, 2020 and Nov 3, 2020 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K170648, 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO COMPLAINS OF SORENESS AND STIFFNESS. THE SURGEON EXPLANTED THE FEMORAL COMPONENT AND DOWNSIZED IT FROM AN ANTHEM CR SIZE 8 TO A LEGION PS SIZE 7 AND ALSO REPLACED THE INSERT FROM A CR 9MM TO A PS 11MM.

    Patient problems: Pain

    MAUDE report 10781784 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170648, 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

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page