GENESIS II 71440192Recalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 03596010214386), received between Dec 6, 2018 and Mar 20, 2026 — classified as 12 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Break” (56 reports).

2 other recalls cover devices cleared under the same FDA submission (K123598); 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 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII TIBIAL BASE IMPACTOR WAS DAMAGED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649247 ↗
• MalfunctionMar 20, 2026Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII TIBIAL BASE IMPACTOR WAS CRACKED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649167 ↗
• MalfunctionOct 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKR SURGERY, ONE (1) FEMORAL TIBIAL SPACER BROKE. ALL PIECES FELL OUTSIDE THE PATIENT AND WERE ACCOUNTED. THE PROCEDURE WAS COMPLETED WITH AN EQUIVALENT S+N BACK UP PRODUCT, AFTER A NON-SIGNIFICANT DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23205666 ↗
• MalfunctionJun 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, AFTER IMPACTION IT WAS NOTICED THAT ONE (1) GII TIBIAL BASE IMPACTOR HAD BROKEN. THE SITE WAS CHECKED TO CONFIRM NO PIECES WERE IN THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355173 ↗
• MalfunctionMar 17, 2025Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII TIBIAL BASE IMPACTORS WERE BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619932 ↗
• MalfunctionDec 31, 2024Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII TIBIAL BASE IMPACTORS WERE BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047264 ↗
• MalfunctionNov 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, THE GII TIBIAL BASE IMPACTOR'S PLASTIC SPLINTERED DURING USE. ALL PLASTIC WAS REMOVED FROM THE WOUND, IN AN UNKNOWN WAY. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20653187 ↗
• MalfunctionMay 8, 2024Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT DURING A TKA SURGERY, USING A GII TIBIAL BASE IMPACTOR, IT WAS FOUND THAT THE RUBBERIZED SURFACE WAS VERY BRITTLE AFTER A SHORT PERIOD OF USE AND WOULD SPLINTER IF HIT IN THE SURGICAL AREA. HOWEVER, AN ABDOMINAL DRAPE WAS USED TO ENSURE THAT NO SPLINTERS ENTERED THE BODY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274688 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A TKA, THE PLASTIC BUMPERS ON THE GII TIBIAL BASE IMPACTOR BROKE. ALL PIECES WERE RECOVERED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021342 ↗
• MalfunctionNov 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII TIBIAL BASE IMPACTOR FRACTURED DOWN THE CENTER. THE DEVICE FRACTURED WHILST IN USE, BUT THE PIECES REMAINED TOGETHER/INTACT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED, NO PIECES FELL INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18210050 ↗
• MalfunctionNov 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, WHEN IMPACTING THE TIBIAL IMPLANT A GII TIBIAL BASE IMPACTOR FRACTURED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209398 ↗
• MalfunctionJan 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TKA SURGERY, ONE (1) GII TIBIAL BASE IMPACTOR FRACTURED WHILE IMPACTING TIBIA. THE PIECES DID NOT FELL INTO PATIENT, ALL OF THEM WERE RETRIEVED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. 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 16189887 ↗
• InjuryOct 18, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A TKA, WHEN IMPACTING THE TIBIAL TRAY, SHARDS OF PLASTIC WERE COMING OFF THE GII TIBIAL BASE IMPACTOR AND FALLING IN THE WOUND. ALL BROKEN PIECES REMOVED WITH FORCEPS. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15626678 ↗
• MalfunctionJun 19, 2022Break; Break

  IT WAS REPORTED THAT, FIVE (5) GII TIBIAL BASE IMPACTORS WERE FOUND WITH BLACK PLASTIC CHIPPING. AS THIS WAS NOTICE DURING SET UP OR INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741402 ↗
• MalfunctionJun 13, 2022Break; Break

  IT WAS REPORTED THAT, THERE WAS CHIP IN THE GII TIBIAL BASE IMPACTOR PLASTIC. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14678219 ↗
• MalfunctionMay 12, 2022Crack; Crack

  IT WAS REPORTED THAT THE HEAD OF THE GII TIBIAL BASE IMPACTOR WAS CRACKED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14380408 ↗
• MalfunctionMay 4, 2022Crack; Crack

  IT WAS REPORTED THAT A GII TIBIAL BASE IMPACTOR CRACKED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283743 ↗
• InjuryApr 28, 2022Material Fragmentation; Naturally Worn; Material Fragmentation; Naturally Worn

  IT WAS REPORTED THAT, DURING TKA SURGERY, THE GENESIS II TIBIAL BASEPLATE IMPACTOR IS LEAVING BLACK BITS IN THE PATIENT DURING USE, DUE TO WEAR AND TEAR. A THOROUGH WASHOUT WAS PERFORMED TO AVOID ANY BITS BEING LEFT IN THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14246271 ↗
• InjuryApr 25, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GII TIBIAL BASE IMPACTOR WAS PRODUCING THIRD BODY WEAR IN THE JOINT WHEN PLACING THE FINAL IMPLANT. THE JOINT WAS PULSE LAVAGED TO TRY AND REMOVE ANY PARTICULATES. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT DELAY. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191580 ↗
• MalfunctionApr 21, 2022Crack; Crack

  IT WAS REPORTED THAT THE GII TIBIAL BASE IMPACTOR WAS CRACKED. AS THIS WAS NOTICED UPON INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14177218 ↗
• MalfunctionApr 9, 2022Break; Break

  IT WAS REPORTED THAT, THE BLACK TIP OF THE GII TIBIAL BASE IMPACTOR BROKE. AS THIS WAS NOTICE IN A FIELD INSPECTION, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14068644 ↗
• MalfunctionMar 31, 2022Break; Break

  IT WAS REPORTED THAT THE TIP OF THE GII TIBIAL BASE IMPACTOR IS CHIPPING OFF. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13961973 ↗
• MalfunctionMar 29, 2022Crack; Crack

  IT WAS REPORTED THAT A GENESIS II TIBIAL BASEPLATE IMPACTOR IS CRACKED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13934850 ↗
• MalfunctionMar 17, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY, IT WAS NOTICED THAT THE GII TIBIAL BASE IMPACTOR HAS BROKEN DOWN FROM REPEATED USE. AS THIS HAPPENED AFTER SURGERY, THE PATIENT WAS NO LONGER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13795915 ↗
• InjuryMar 16, 2022Break; Break

  IT WAS REPORTED THAT, DURING TOTAL KNEE ARTHROPLASTY, THE PLASTIC TIP OF A GENESIS II TIBIAL BASEPLATE IMPACTOR CHIPPED OFF WHILE IMPACTING, INSIDE THE PATIENT. THE PIECES WERE REMOVED BY HAND AND TWEEZERS. SURGERY WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED BEYOND THE PROBLEM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13777795 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.

• Z-0730-2019 · Jan 7, 2019 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116