GENESIS II 71441152Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010497208), received between Jun 19, 2020 and Apr 16, 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 16, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY THE GENESIS II MIS DCF AP CT BLK FROM SIZE 4 WAS HAVING ISSUES FITTING. NO DELAY OR INJURY REPORTED. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. AFTER PRODUCT EVALUATION IT WAS DETERMINED THAT THE DEVICE IS HEAVILY WORN WITH MANY NICKS, SCRATCHES, AND BURRS AROUND THE CUTTING SLOTS. 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 11682871 ↗
• MalfunctionJan 28, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE OF THE PIN HOLES BY THE BOX OF THE GENESIS II SIZE 4 A-P CUTTING BLOCK DEVICE ARE UNPASSABLE WITHOUT FORCE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. 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 11242907 ↗
• MalfunctionSep 10, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE GII MIS DCF AP CT BLK 4 IS WORN FROM EXCESSIVE USE. NOT CASE WAS INVOLVED. NO PATIENT HARM OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10517996 ↗
• 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 10176726 ↗

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