ANTHEM 71422668Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556583937), received between Aug 21, 2019 and Jun 16, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, AN ANTHEM PS HF INSERT SZ 3-4 11MM (CASE-2021-00057296-1) INSERT WAS NOTICED TO BE BROKEN WHEN THE PACKAGING WAS OPENED BEFORE USE. A DELAY OF LESS THAN 30 MINUTES OCCURRED DUE TO THIS EVENT, AND THE PROCEDURE WAS CONCLUDED USING A SMITH AND NEPHEW BACKUP INSERT. NEITHER PATIENT INJURY NOR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011128 ↗
• MalfunctionMar 5, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING AN UNSPECIFIED SURGERY THE SURGEON FOUND IT DIFFICULT TO LOCK THE POLY INSERT ANTHEM PS HF INSERT SZ 3-4 11MM WHILE DOING THE FINAL IMPLANTATION ON THE TIBIAL TRAY. SURGEON MADE SEVERAL ATTEMPTS FOR FIXATION, HOWEVER THE INSERT WAS NOT LOCKING PROPERLY. THUS IT WAS REPLACED WITH ANOTHER INSERT OF THE SAME SIZE AND IT FINALLY LOCKED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11423377 ↗
• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED ON PATIENTS RIGHT KNEE. TIMELINE: ON (B)(6) 2019 FEVER SYMPTOMS BEGIN. ON (B)(6) 2019 PATIENT VISITED THE HOSPITAL. ON (B)(6) 2019 REVISION SURGERY. IRRIGATION AND DRAINAGE PERFORMED. INSERT REMOVED AND REPLACED.

  Patient problems: Injury

  MAUDE report 9557525 ↗
• InjuryAug 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PERCUTANEOUS INFERIOR VENA CAVA RETRIEVABLE FILTER IMPLANTATION WAS PERFORMED UNDER LOCAL ANESTHESIA DUE TO DEEP VENOUS THROMBOSIS.

  Patient problems: Injury

  MAUDE report 8919242 ↗

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-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-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-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
• 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