GENESIS II 71433356Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556032725), received between Sep 25, 2020 and Oct 11, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2022Crack; Material Fragmentation; Crack; Material Fragmentation

  IT WAS REPORTED THAT, AFTER CLEANING WHEN THE SET WAS BEING RE-ASSEMBLED, IT WAS FOUND THAT METAL SEPARATED/CRACKED FROM A GII SPC REAMTHRU CR TR SZ 6 RT. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15577859 ↗
• MalfunctionMar 30, 2022Break; Break

  IT WAS REPORTED THAT THE GII SPC REAMTHRU CR TR SZ 6 RT BROKE. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13945924 ↗
• MalfunctionDec 14, 2021Crack; Crack

  IT WAS REPORTED THAT THE GII SPC REAMTHRU CR TR SZ 6 RT WAS FOUND CRACKED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005045 ↗
• MalfunctionAug 26, 2021Crack; Crack

  IT WAS REPORTED THAT A GENESIS II SPC REAMTHRU CR TR SIZE 6 RIGHT HAS CRACKS ON THE UNDERSIDE OF THE TRIAL. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NO CASE OR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12374466 ↗
• MalfunctionJul 29, 2021Crack; Crack

  IT WAS REPORTED THAT A GENESIS II SYMMETRICAL POSTERIOR CONDYLES REAM THROUGH CRUCIATE RETAINING TRIAL SIZE 6 RIGHT WAS FOUND WITH A CRACK IN IT. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250755 ↗
• MalfunctionNov 4, 2020Crack; Crack

  IT WAS REPORTED THAT, WHILE INSPECTING INSTRUMENTS, A SLIGHT CRACK WAS NOTICED IN THE TRIALS. NO PATIENT WAS INVOLVED. 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; No Patient Involvement

  MAUDE report 10788404 ↗
• MalfunctionSep 25, 2020Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE FEMORAL TRIALS WERE FOUND CRACKED. THIS WAS DISCOVERED AFTER THE CASE. NO PATIENT WAS AFFECTED OR DELAYS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10587991 ↗

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