GENESIS II 71933043Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556059951), received between Mar 26, 2019 and Jul 30, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionJul 30, 2022Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GENESIS II SPC F/E SZ GDE BROKE. NO PIECES FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136780 ↗
• MalfunctionNov 11, 2021Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT, DURING SURGERY, THE GENESIS II SPC F/E SZ GDE WAS FOUND BROKEN: THE ROD WOULD NOT ATTACH PROPERLY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT HARMED. ON INVESTIGATION RESULTS IT WAS FOUND THAT THE CONNECTING FEATURE WAS OVERSIZE ON THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12800899 ↗
• MalfunctionApr 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING AN UNKNOWN PROCEDURE, THE GENESIS II SPC F/E SZ GDE AND JOURNEY F/E GAP BAL SZ GDE HEX BOLT THAT HOLD THE MECHANISM TOGETHER WERE STRIPPED AND WILL NOT SEAT THE INSERTION PEG FLUSH WITH THE REST OF THE MECHANISM. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED (ABOUT 5 MINUTES), AS THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP DEVICE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683756 ↗
• MalfunctionMar 26, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SURGERY THE BALANCE MEASUREMENT TOOL OF THE KNEE JOINT DID NO MARK THE LINE, AND IT CANNOT CORRECTLY MARK THE OSTEOTOMY. THERE WAS NOT AN S&N BACKUP DEVICE AVAILABLE AND THE SURGEON HAD TO USE REGULAR TOOLS INSTEAD AND DIVERT FROM THE ORIGINAL PROCEDURE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8452269 ↗

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