GENESIS II 71441153Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03596010497215), received between Feb 10, 2019 and Feb 5, 2023 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII MIS DCF AP CT BLK 5 WAS BENT AND BROKE OFF. BROKEN PARTS WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16302085 ↗
• MalfunctionOct 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, ONE OF THE HOLDING PINS ON THE BACK OF THE GII MIS DCF AP CT BLK 5 BROKE OFF. AS THIS WAS NOTICE WHILE CLEANING, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15675023 ↗
• MalfunctionOct 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE GII MIS DCF AP CT BLK 5 IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15577408 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP, THE PIN ON POSTERIOR OF GII MIS DCF AP CT BLK 5 WAS BROKEN. PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13710913 ↗
• MalfunctionAug 18, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PEG OF A GENESIS II MINIMALLY INVASIVE DISTAL CUT FIRST ANTERIOR POSTERIOR CUTTING BLOCK SIZE 5 BROKE OFF. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12340239 ↗
• InjuryAug 16, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE PEG OF A GII MIS DCF AP CT BLK 5 BROKE OFF INSIDE THE PATIENT. SURGERY WAS RESUMED, WITH A BACK-UP DEVICE, IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12329271 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT THE CUTTING SLOT OF THE GII MIS DCF AP CT BLK 5 WAS CHIPPED. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803149 ↗
• 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 11586562 ↗
• MalfunctionMar 1, 2021Break; Break

  IT WAS REPORTED THAT DURING USE, OUTSIDE THE PATIENT, THE SPIKES BROKE OFF. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391232 ↗
• MalfunctionFeb 11, 2021Break

  IT WAS REPORTED THAT DURING TKA PROCEDURE THE SPIKE OF THE GENESIS II MIS DCF AP CT BLK 5 BROKE OFF WHILE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY WITH AN SMITH&NEPHEW BACKUP DEVICE. NO PATIENT HARM OR ADDITIONAL COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11319821 ↗
• MalfunctionSep 10, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE GII MIS DCF AP CT BLK 5 IS WORN FROM EXCESSIVE USE. NO CASE WAS INVOLVED. NO PATIENT HARM OR SURGICAL DELAY WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10518192 ↗
• 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 10176747 ↗
• MalfunctionJun 8, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING SURGERY, THE UPPER RIGHT PIN HOLE WAS WORN AND PINS WERE STICKING. THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS FINISHED WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10127304 ↗
• MalfunctionFeb 10, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE METAL PIECE BETWEEN CHAMFER CUT GUIDES BROKE OFF. A BACKUP DEVICE WAS AVAILABLE AND NO DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8324772 ↗

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