GENESIS II 71433357Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00885556031582), received between Feb 11, 2019 and Sep 16, 2025 — classified as 1 injury, 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA SURGERY, A FEMUR WAS REMOVED TO RECUT DISTAL FEMUR AND PLACED FEMUR BACK ON PATIENT. IT WAS USED A FEMUR IMPACTOR HANDLE TO IMPACT FEMUR WITHOUT ENGAGING LOCKING MECHANISM AND USED IMPACTOR AS A SECONDARY IMPACTOR, BUT TWO PIECES OF METAL BROKE OFF THE GII SPC REAMTHRU CR TR SZ 7 RT. IT IS UNKNOWN IF PIECES FELL INSIDE THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063549 ↗
• MalfunctionAug 5, 2021Crack; Crack

  IT WAS REPORTED THAT GII SPC REAMTHRU CR TR SZ 7 RT WAS FOUND CRACKED WHERE CAM SITS. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285675 ↗
• MalfunctionMay 18, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A TKA, THE BOLT OF THE GII SPC P/S HOUS COLLET S 3-8 ((B)(4)) GOT CROSS THREADED IN THE GII SPC REAMTHRU CR TR SZ 7 RT ((B)(4)) AND CAME APART. THE SURGEON COULD NOT GET THE COLLETT OFF OF THE TRIAL. NO SURGICAL DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH SMITH AND NEPHEW BACK-UP DEVICES. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842291 ↗
• MalfunctionMay 18, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A TKA, THE BOLT OF THE GII SPC P/S HOUS COLLET S 3-8 ((B)(4)) GOT CROSS THREADED IN THE GII SPC REAMTHRU CR TR SZ 7 RT ((B)(4)) AND CAME APART. THE SURGEON COULD NOT GET THE COLLETT OFF OF THE TRIAL. NO SURGICAL DELAY WAS REPORTED AND THE PROCEDURE WAS FINISHED WITH SMITH AND NEPHEW BACK-UP DEVICES. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11842196 ↗
• MalfunctionMay 10, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A ROUTINE INSPECTION A GII SPC REAMTHRU CR TR SZ 6 LT (CASE: (B)(4)) AND A GII SPC REAMTHRU CR TR SZ 7 RT (CASE: (B)(4)) WERE FOUND CRACKED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803363 ↗
• MalfunctionMar 22, 2021Break; Break

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, WAS FOUND THAT THE GII SPC REAM THROUGH CR TRIAL SIZE 7 RIGHT IS BROKE WHERE THE CAM SITS IN BOX. THERE WAS NO CASE 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

  MAUDE report 11541327 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA WAS NOTICED THE FEMORAL TRIAL BROKE WHERE SLAP/EXTRACTOR SLIDES ONTO TRIAL. INCIDENT OCCURRED AFTER THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431756 ↗
• MalfunctionDec 28, 2020Crack; Crack

  IT WAS REPORTED DURING THE TKA PROCEDURE THAT THE FEMUR WAS CRACKED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY, USING A BACKUP FROM SMITH & NEPHEW. NO PATIENT INJURY OR 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 11083961 ↗
• 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 10588204 ↗
• InjurySep 8, 2020Break; Break

  IT WAS REPORTED THAT DURING A CASE, TRIAL BROKEN WHILE INSIDE THE PATIENT. ALL PIECES WERE RECOVERED AND PATIENT WAS NOT AFFECTED. A DELAY OF LESS THAN 30 MINUTES WAS REPORTED AND IT IS UNKNOWN HOW THE PROCEDURE WAS CONCLUDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10505254 ↗
• MalfunctionAug 21, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING STANDARD OFFICE EFIP INSPECTION THE GENESIS II SPC REAM THROUGH TRIAL SIZE 7 RIGHT WAS NOTICED WITH THE METAL DENTED AND WORN. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10437060 ↗
• MalfunctionFeb 11, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE PIECE BROKE OFF NEAR GAP IN THE MIDDLE. NO BROKEN PIECE WAS LEFT IN THE PATIENT OR FELL IN THE PATIENT. NO HARM TO THE PATIENT WAS RECORDED. A BACKUP DEVICE WAS AVAILABLE AND NO DELAY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8325138 ↗

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