ANTHEM 71422667Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556583944), received between Mar 24, 2018 and Apr 28, 2026 — classified as 6 injuries, 3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA, AN ANTHEM PS HF INSERT SZ 3-4 9MM DID NOT SEAT ONTO THE TIBIA. THE PROCEDURE WAS RESUMED, AFTER A SURGICAL DELAY GREATER THAN 30 MINUTES WITH A SMITH AND NEPHEW BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25013537 ↗
• InjurySep 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AN ANTHEM PS HF INSERT SZ 3-4 9MM BROKE. IT IS UNKNOWN HOW THE SURGERY WAS FINISHED AND IF IT WAS DELAYED. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12545249 ↗
• MalfunctionMay 12, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING TKA SURGERY, THE ANTHEM PS HF INSERT SZ 3-4 9MM COULDN'T BE IMPLANTED. A SMITH AND NEPHEW SAME SIZE INSERT BACK UP DEVICE WAS AVAILABLE. NO INJURY REPORTED. IT IS UNKNOWN IF THERE WAS A SIGNIFICANT DELAY. 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 11813509 ↗
• MalfunctionApr 2, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE ANTHEM PS HF INSERT SZ 3-4 9MM WAS NOT LOCKING PROPERLY FROM MEDIAL SIDE DURING FINAL IMPLANTATION. SURGEON TRIED TWICE TO PLACE THE INSERT, HOWEVER THE INSERT WAS EASILY COMING OUT OF TIBIAL TRAY. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. SURGICAL DELAY OF LESS THAN OR EQUAL TO 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11610697 ↗
• InjuryFeb 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AFTER EIGHT MONTHS OF SURGERY, A REVISION WAS PERFORMED DUE TO THE INSERT THAT DISLOCATED WITHOUT TRAUMA AND WAS FOUND DAMAGED.

  Patient problems: Injury

  MAUDE report 9720228 ↗
• InjuryJan 13, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  (B)(6). IT WAS REPORTED A STIFF RIGHT KNEE SO A PROCEDURE WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 9580103 ↗
• 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 8919243 ↗
• InjurySep 5, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED FOR A REMOVAL OF THE INSERT AND FEMUR COMPONENT AS THE PATIENT WAS EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 7849183 ↗
• InjuryMar 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POLY REMOVAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7368683 ↗

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-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-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-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-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