GENESIS II 71441265Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00885556034354), received between Dec 9, 2019 and Oct 20, 2023 — classified as 1 injury, 24 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2023Break; Break

  IT WAS REPORTED THAT, DURING A TKA THE PLASTIC RING OF A GII SPC PRI SPACER BLOCK WAS BROKEN. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE AND NO PIECES FELT INTO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17978226 ↗
• MalfunctionSep 12, 2023Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, A SPACER SHIM COULD NOT BE PLACED INTO A GII SPC PRI SPACER BLOCK. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. UPON INSPECTION, IT WAS NOTED THAT THE INNER WHITE LOCKING CLIP IN THE GII SPC PRI SPACER BLOCK HAD BROKEN, AND BECOME DISLODGED, BLOCKING THE ACCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17729977 ↗
• MalfunctionFeb 8, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, NURSES WERE UNABLE TO SNAP SPACER SIZED INTO GII SPC PRI SPACER BLOCK, WHITE RINGS APPEAR TO BE BROKEN INSIDE OF SPACER BLOCK. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 16327139 ↗
• MalfunctionAug 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA, IT WAS DIFFICULT TO PUT THE GII SPC PRI SPACER BLOCK TOGETHER. APPEARS PLASTIC RINGS IN BLOCK ARE BROKEN. THE SURGERY FINISHED WITH THE SAME DEVICE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319386 ↗
• MalfunctionAug 30, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING TKA, IT WAS DIFFICULT TO PUT THE GII SPC PRI SPACER BLOCK TOGETHER. APPEARS PLASTIC RINGS IN BLOCK ARE BROKEN. THE SURGERY FINISHED WITH THE SAME DEVICE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319318 ↗
• MalfunctionJun 6, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IN TWO (2) GII SPC PRI SPACER BLOCK THE PLASTIC LOCKING MECHANISM WAS FRACTURED/CRACKED AFTER MANY USES. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14609036 ↗
• MalfunctionMay 27, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP FOR A TKA SURGERY, IT WAS NOTICED THAT THE INNER PLASTIC RING ON THE GII SPC PRI SPACER BLOCK IS BROKEN AND WILL NOT RETAIN THE TRIAL. THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520225 ↗
• MalfunctionMay 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE WHITE RING OF A GII SPC PRI SPACER BLOCK WAS MISSING. AS THIS WAS NOTICED UPON CLEANING AND STERILIZATION ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517602 ↗
• MalfunctionMay 18, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GII SPC PRI SPACER BLOCK IS MISSING THE LOCKING RING. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14432140 ↗
• MalfunctionApr 9, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GII SPC PRIMARY SPACER BLOCK IS MISSING THE PLASTIC O-RINGS. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068444 ↗
• MalfunctionDec 27, 2021Break; Break

  IT WAS REPORTED THAT A GENESIS II SPACER PRIMARY SPACER BLOCK IS BROKEN. THE CONTEXT IN WHICH THIS OBSERVATION WAS MADE IS UNSPECIFIED. THEREFORE, PATIENT INVOLVEMENT IS YET TO BE CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 13090809 ↗
• MalfunctionDec 13, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE PIECE OF O-RING INSIDE GII SPC PRI SPACER BLOCK HAS BROKEN OFF WHILE OUTSIDE THE PATIENT. THE DEVICE CHIPPED UPON REMOVAL AND THE PIECE WAS HANGING ON SLIGHTLY. NO PIECES FELL INSIDE THE PATIENT. IT IS UNKNOWN IF THERE WAS A S&N BACKUP DEVICE AVAILABLE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12988231 ↗
• MalfunctionNov 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE PLASTIC PIECE THAT HOLDS THE GII SPC PRIMARY SPACER BLOCK WAS BROKEN. SURGERY WAS COMPLETED WITH A BACKUP DEVICE, WITHOUT ANY DELAY. NO PIECES FELL INTO THE PATIENT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796993 ↗
• MalfunctionJul 14, 2021Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII SPC PRI SPACER BLOCK WAS WORN OUT AND ITS WHITE LOCKING RING IS MISSING. IT IS UNKNOWN HOW THE PROBLEM WAS SOLVED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171052 ↗
• MalfunctionJun 29, 2021Break; Break

  IT WAS REPORTED THAT, THE INNER RING OF GII SPC PRI SPACER BLOCK WAS BROKEN AND WILL NOT RETAIN SPACER PLATE. NO CASE INVOLVED; THEREFORE, NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086162 ↗
• MalfunctionMay 7, 2021Loose or Intermittent Connection; Component Missing; Loose or Intermittent Connection; Component Missing

  IT WAS REPORTED THAT THE WHITE RETAINING RINGS OF THE GII SPC PRI SPACER BLOCK WERE MISSING. AS THIS WAS NOTICED UPON INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11794854 ↗
• MalfunctionDec 16, 2020Crack; Naturally Worn; Crack; Naturally Worn

  IT WAS REPORTED THAT THE GII SPC PRI SPACER BLOCK IS PRESENTING WEAR AND TEAR. IT HAS CHIPS AND CRACKS. NO CASE RELATED. 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 11016799 ↗
• MalfunctionNov 13, 2020No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED, THAT DURING TKA THE WHITE O RINGS ARE GONE AND WILL NOT HOLD ON CLIP ON BUILD UPS. THE PROCEDURE FINISHED WITH THE SAME DEVICE. NO SURGICAL DELAY. NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10837290 ↗
• MalfunctionSep 22, 2020Break; Break

  IT WAS REPORTED THAT DURING TKA SURGERY, OUTSIDE THE PATIENT WAS NOTICED THAT THE WHITE O RINGS OF THE GENESIS II SPC PRI SPACER BLOCK ARE BROKE AND WILL NOT HOLD ON CLIP ON BUILD UPS. THE PROCEDURE WAS FINISHED USING THE SAME DEVICE, WITH NO SURGICAL DELAY AND NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10564970 ↗
• MalfunctionSep 21, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT DURING SURGERY, THE WHITE O RINGS ARE GONE AND DEVICE WOULD NOT HOLD ON CLIP ON BUILD UPS. THERE WAS NO DELAY AND NO INJURY. PROCEDURE CONCLUDE WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10558538 ↗
• MalfunctionSep 21, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT DURING SURGERY, THE WHITE O RINGS ARE GONE AND DEVICE WOULD NOT HOLD ON CLIP ON BUILD UPS. THERE WAS NO DELAY AND NO INJURY. PROCEDURE CONCLUDE WITH THE SAME DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10558498 ↗
• MalfunctionSep 21, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT DURING SURGERY, THE WHITE O RINGS ARE GONE AND DEVICE WOULD NOT HOLD ON CLIP ON BUILD UPS. THERE WAS NO DELAY AND NO INJURY. IT'S UNKNOWN HOW THE PROCEDURE CONCLUDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10558491 ↗
• InjurySep 16, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY, WHILE OUTSIDE THE PATIENT, DEVICE WAS NOTICED TO HAVE THE PLASTIC GASKET BROKEN. PROCEDURE WAS CONCLUDED USING A DOUBLE SIDED SPACER BLOCK. THERE WAS NO INJURY OR DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10539585 ↗
• MalfunctionJul 14, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PLASTIC RING ON THE INNER MOUNT OF A SPACER BLOCK BROKE OFF. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10273453 ↗
• MalfunctionDec 9, 2019Break; Break

  IT WAS REPORTED THAT THE PLASTIC LOCKING RING ON THE DEVICE BROKE DURING SURGERY. NO DELAY REPORTED. NO PATIENT INJURIES REPORTED. NO S&N BACKUP WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9440303 ↗

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