GENESIS II 71441151Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010497192), received between Jun 19, 2020 and Apr 7, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (2 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.

• MalfunctionApr 7, 2021Failure to Align; Naturally Worn; Failure to Align; Naturally Worn

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY THE GENESIS II MIS DCF AP CT BLK FROM SIZE 3 TO 8 ARE HAVING ISSUES FITTING. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632338 ↗
• MalfunctionMar 29, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, COMPONENT ARE UNFIT FOR USE. THE GII MIS DCF AP CT BLK 3 HAVE BURRS. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586430 ↗
• MalfunctionSep 10, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE GII MIS DCF AP CT BLK 3 IS WORN FROM EXCESSIVE USE AND NEED TO BE REPLACED. THERE WAS NO CASE INVOLVED. NO PATIENT HARM OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10517912 ↗
• InjuryJun 19, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT AFTER PROCEDURE TKA THE SURGEON DID NOT NOTICE THE MISSING PEG FROM THE CUTTING BLOCK UNTIL POSTOPERATIVE X-RAY (DURING THE PROCEDURE THE SURGEON FOLLOWED PROPER TECHNIQUE IN PLACEMENT AND REMOVAL OF THE 4 IN 1 CUTTING BLOCK). THE PROCEDURE WAS COMPLETED WITHOUT DELAY.

  Patient problems: Injury

  MAUDE report 10176686 ↗

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