GENESIS II 71421515Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 03596010492371), received between Sep 18, 2017 and Apr 5, 2026 — classified as 40 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Fracture” (8 reports).

6 other recalls cover devices cleared under the same FDA submission (K032295); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER TKA HAD BEEN PERFORMED ON 14 YEARS AGO, THE PATIENT STARTED TO BECOME SORE, SCAN SHOWED THE TIBIA WAS LOOSE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2026, IN WHICH DOCTOR REMOVED ONE (1) GII PS HI FLEX ISRT SZ 5-6 9MM AND ONE (1) GNS II CMT TIB SIZE 6 RIGHT, AND REPLACED THEM WITH LEGION REVISION STEMMED TIBIA AND BASEPLATE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 24786767 ↗
• InjuryMar 25, 2026Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON 2018, THE PATIENT EXPERIENCED SUDDEN A/P INSTABILITY AND REPORTED A ¿POP SENSATION¿ DUE TO THE BREAKAGE OF ONE (1) GII PS HI FLEX ISRT SZ 5-6 9MM. THIS ADVERSE EVENT WAS SOLVED BY A TKA REVISION SURGERY ON (B)(6) 2026, IN WHICH THE DEVICE WAS EXPLANTED, REPLACED FOR A GII PS HI FLEX ISRT SZ 5-6 11 AND THE INSTABILITY WAS REMEDIED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 24688839 ↗
• InjuryMar 4, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (b)(6)2025, THE GII PS HI FLEX ISRT SZ 5-6 9MM DISLOCATED. THIS ADVERSE EVENT WAS ADDRESSED BY PERFORMING A REVISION SURGERY ON (b)(6)2026, DURING WHICH, THE GII PS HI FLEX ISRT SZ 5-6 9MM WAS EXCHANGED TO AN EQUIVALENT INSERT. PATIENT IS CURRENTLY DOING WELL.

  Patient problems: Joint Dislocation

  MAUDE report 24506030 ↗
• MalfunctionFeb 3, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, SHIM INSERTER STRUCK THE GII PS HI FLEX ISRT SZ 5-6 9MM REPEATEDLY AND FAILED TO IMPLANT, THE PROSTHESIS TRENCH COULD NOT TRAP THE INSERT. FINALLY, THE GII PS HI FLEX ISRT SZ 5-6 9MM WAS REPLACED FOR A SAME TYPE INSERT. THE PROCEDURE WAS COMPLETED, AFTER A DELAY GREATER THAN 30 MINUTES. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21293153 ↗
• InjuryDec 27, 2024Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING TKA, IT WAS FOUND THAT THE OUTER PACKAGING OF ONE (1) GII PS HI FLEX ISRT SZ 5-6 9MM WAS INTACT WITH NO SIGNS OF TAMPERING, BUT THE INNER AND OUTER TRAYS WERE UNSEALED AND NOT STERILE. WITH ONLY ONE PROSTHESIS OF EACH SIZE ON HAND, THE SURGEON WAS FORCED TO USE AN 11 MM PROSTHESIS INSTEAD. THE SURGEON NOTED THAT THIS SWITCH REQUIRED ADDITIONAL BONE RESECTION, WHICH COULD POTENTIALLY HARM THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: Laceration(s)

  MAUDE report 21031321 ↗
• InjuryOct 31, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED IN 2009, THE PATIENT EXPERIENCED CHUNKINESS WITH MOVEMENT, THE PATIENT WAS DIAGNOSED AS POST BREAKAGE. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH A GII PS HI FLEX ISRT SZ 5-6 9MM WAS EXCHANGED AND PATELLA WAS RESURFACED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Loss of Range of Motion

  MAUDE report 20579760 ↗
• InjurySep 25, 2024Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA SURGERY WAS PERFORMED IN 2004, THE POST ON A GII PS HI FLEX ISRT SZ 5-6 9MM BROKE OFF. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE INSERT WAS REPLACED. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 20302464 ↗
• InjuryAug 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2008, THE POST OF AN GII PS HI FLEX ISRT SZ 5-6 9MM BROKE, ON A HIGH DEMAND PATIENT, WHEN GOING DOWNSTAIRS. SINCE THE PATIENT HAD ANTERIOR/POSTERIOR INSTABILITY A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN, NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 20081962 ↗
• MalfunctionMay 6, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, IT WAS NOTICED THAT ONE (1) GII PS HI FLEX ISRT SZ 5-6 9MM COULDN'T LOCK TIGHTLY AFTER SEVERAL TIMES. THE PROCEDURE WAS RESUMED, AFTER A 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 19248865 ↗
• InjuryDec 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2008, THE POST OF THE GII PS HI FLEX ISRT SZ 5-6 9MM BROKE. THIS EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2023, WHERE THE GII PS HI FLEX ISRT SZ 5-6 9MM WAS REPLACED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 18322617 ↗
• InjuryNov 3, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON AN UNDISCLOSED DATE, THE PATIENT EXPERIENCED PAIN. IN ORDER TO TREAT THIS ADVERSE EVENT, A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2023. DURING THE PROCEDURE, IT WAS FOUND THAT THE INSERT WAS BROKEN AND THE GII PS HI FLEX ISRT SZ 5-6 9MM WAS EXCHANGED. THE PATIENT IS RECOVERING.

  Patient problems: Arthralgia; Failure of Implant

  MAUDE report 18066301 ↗
• MalfunctionSep 19, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA PROCEDURE, A GII PS HI FLEX ISRT SZ 5-6 9 COULDN'T BE IMPLANTED. THE PROCEDURE WAS RESUMED, AFTER A 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 17777947 ↗
• MalfunctionJul 25, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT, DURING A TKA SURGERY, A GII PS HI FLEX ISRT SZ 5-6 9 WAS UNABLE TO BE IMPLANTED PROPERLY, IT WAS FALLING OUT AS SOON IT WAS RESET. THE PHYSICIAN TRIED TO PLACE IT SEVERAL TIMES, WITHOUT SUCCESS. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, WITH A SAME SIZE BACK-UP DEVICE. PATIENT REQUIRED ADDITIONAL ANESTHESIA BECAUSE OF THE DELAY IN PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393242 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 WEEKS AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, A WASHOUT AND GII PS HI FLEX ISRT SZ 5-6 9 DEVICE EXCHANGE WAS PERFORMED. NO FURTHER INFORMATION IS AVAILABLE AT THIS MOMENT.

  Patient problems: Insufficient Information

  MAUDE report 16428218 ↗
• InjuryFeb 5, 2023Fracture; Fracture

  IT WAS REPORTED THAT AFTER A LEFT TKA SURGERY WAS PERFORMED ON (B)(6) 2013, THE PATIENT STARTED TO FEEL CLICKING IN HIS KNEE 2 YEARS AGO AND INSTABILITY 1 YEAR AGO. THE PS POLY PRESENTED A BROKEN POST. THIS ADVERSE EVENT WAS TREATED WITH A REVISION SURGERY ON (B)(6) 2023, IN WHICH THE GENESIS II POSTERIOR STABILIZED HIGH FLEXION INSERT SIZE 5-6 9MM WAS REMOVED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 16302046 ↗
• InjuryDec 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT AFTER A TKA SURGERY, THE POST OF A GII PS HI FLEX ISRT SZ 5-6 9. A REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2022 TO TREAT THIS EVENT WHERE THE INSERT WAS EXCHANGED. PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16048673 ↗
• InjuryMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED APPROXIMATELY 1 YEAR AGO, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2022 TO REVISE THE GII PS HI FLEX ISRT SZ 5-6 9 DUE TO STIFFNESS AND LACK OF RANGE OF MOTION. THE SURGEON OPENED THE JOINT AND DID SOFT TISSUE RELEASES AND BALANCING. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. OUTCOME RESOLVED.

  Patient problems: Loss of Range of Motion

  MAUDE report 14539236 ↗
• InjuryFeb 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A SURGERY PERFORMED ON (B)(6) 2012, THE PATIENT EXPERIENCED PAIN, THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 TO REMOVE THE IMPLANT. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 13615115 ↗
• MalfunctionDec 30, 2021Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT THE GENESIS II PS HI FLEX INSERT SIZE 5-6 9 CANNOT BE LOCKED WITH THE BASEPLATE AND IT IS BROKEN. THERE WAS A DELAY GREATER THAN 30 MINUTES AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118818 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED RECURRENT EFFUSIONS AND MILD JOINT INSTABILITY. TWO ASPIRATES WERE PERFORMED WITH NO GERM GROWTH. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY TO EXPLORE THE JOINT ON (B)(6) 2021. ONLY THE POLY INSERT WAS EXCHANGED WITH A THICKER ONE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity; Swelling/ Edema

  MAUDE report 13002082 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED ANTERIOR KNEE PAIN AND THE XRAYS SHOWED DISLOCATED ARTICULAR INSERT, THE ISSUE WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2021.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12968120 ↗
• InjuryNov 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2015, THE PATIENT EXPERIENCED AN ANTERIOR KNEE PAIN, X-RAYS SHOWED A DISLOCATED ARTICULAR INSERT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 12878928 ↗
• MalfunctionNov 19, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII PS HI FLEX ISRT SZ 5-6 9 WAS UNABLE TO BE IMPLANTED NORMALLY, IT WAS FALLING OUT AS SOON IT WAS RESET. THE PHYSICIAN TRIED MORE THAN 10 TIMES, WITHOUT SUCCESS. SURGERY WAS RESUMED, AFTER A DELAY GREATER THAN 30 MINUTES, WITH A BACK-UP DEVICE (A 5-6 11 MM INSERT). PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12844282 ↗
• InjuryNov 15, 2021Break; Break

  IT WAS REPORTED THAT THERE WAS A POTENTIAL INSERT PEG (UNKNOWN ORTHOPEDIC RECONSTRUCTION DEVICE) BREAKAGE. THIS IS A REOCCURRING COMPLAINT - HAPPENED 3 TIMES PREVIOUSLY FOR SAME CUSTOMER. FURTHER INFORMATION IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12811941 ↗
• InjurySep 22, 2021Break; Break

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2007, THE PATIENT EXPERIENCED LOOSENING AND ANTERIOR KNEE PAIN, WHEN THE SURGEON OPENED THE KNEE THE GII PS HI FLEX ISRT SZ 5-6 9 WAS FOUND TO BE BROKE. THIS ADVERSE EVENT WAS TREATED BY REPLACING THE POLY GOING FROM A 9MM TO A 12MM, AND RESURFACING THE PATELLA ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Laxity; Pain

  MAUDE report 12517017 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032295. One submission often covers many models, so check the product and lot details in each record.

• Z-0447-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0444-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0448-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0446-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0449-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic
• Z-0445-2014 · Aug 27, 2013 · Terminated
  GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic