GENESIS II 71433358Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556032312), received between Sep 20, 2020 and May 4, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

4 other recalls cover devices cleared under the same FDA submission (K121393); 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.

• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT A GII SPC REAMTHRU CR TR SZ 8 RT WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14279651 ↗
• MalfunctionFeb 21, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT, DURING THE SET UP FOR A THR SURGERY, THE COLLET OF A GENESIS II SYMMETRICAL POSTERIOR CONDYLES REAM THROUGH CRUCIATE RETAINING TRIAL SIZE 8 RIGHT WON'T FIT AND THE SPIKE ON THE BACK SHEARED OFF. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573310 ↗
• InjuryDec 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE GII SPC REAMTHRU CR TR SZ 8 RT DEVELOPED METAL SHARD AND CUT THE SPD TECH DURING CLEANING PROCESS. THE CURRENT STATE OF HEALTH OF THE SPD TECH IS UNKNOWN.

  Patient problems: Laceration(s)

  MAUDE report 13111588 ↗
• MalfunctionSep 20, 2020Break; Break

  IT WAS REPORTED AFTER THE TRIAL REMOVED FROM THE PATIENT, 2 PIECES OF METAL HAD BROKEN OFF OF THE FEMORAL TRIAL. BOTH PIECES WERE RETRIEVED. NO SURGERY DELAY. NO PATIENT HARM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 10558111 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121393. One submission often covers many models, so check the product and lot details in each record.

• Z-0878-2020 · Dec 16, 2019 · Open, Classified
  LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 714344
• Z-0200-2019 · Sep 18, 2018 · Terminated
  Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to mak
• Z-2163-2018 · May 4, 2018 · Terminated
  smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
• Z-1902-2018 · Apr 9, 2018 · Terminated
  smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic a