ANTHEM 71422843Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556531464), received between Jan 7, 2020 and Jun 10, 2024 — classified as 3 injuries, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K142807, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE ANTHEM TIBIAL BASE PLATE SZ 3 RT COULD NOT LOCK INTO THE ARTICULAR. IT WAS CHANGED THE ARTICULAR TWO TIMES BUT STILL FACED THE SAME ISSUE. THE ANTHEM TIBIAL BASE PLATE SZ 3 RT WAS ALREADY INSERTED INTO PATIENT AND COULD NOT TAKE IT OUT. IT WAS TRIED EVERYTHING BUT STILL COULD NOT LOCK ARTICULAR COMPLETELY SO THIS EVENT COULD CAUSED REVISION IN THE FUTURE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499217 ↗
• InjuryFeb 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT SUFFERED FROM ANEMIA. THE EVENT WAS TREATED VIA TRANSFUSION AND MEDICATION.

  Patient problems: Anemia

  MAUDE report 9739370 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANTHEM CR CLINICAL STUDY 17-4065-07, SUBJECT: 40-022, AE#02. IT WAS REPORTED THAT PATIENT UNDERWENT KNEE MANIPULATION TO RESOLVE A ROM LIMITATION ISSUE.

  Patient problems: Injury

  MAUDE report 9557689 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY (B)(6). SUBJECT: (B)(6). AE#02: IT WAS REPORTED THAT PATIENT UNDERWENT KNEE MANIPULATION TO RESOLVE A ROM LIMITATION ISSUE.

  Patient problems: Injury

  MAUDE report 9557482 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142807, 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