GENESIS II 71420818Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010209580), received between May 11, 2017 and Dec 24, 2025 — classified as 6 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (4 reports).

6 other recalls cover devices cleared under the same FDA submission (K951987); 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THERE WERE PROBLEMS WHEN PLACING ONE (1) GII PS INSERT SZ 3-4 11MM, IT DID NOT FIT CORRECTLY THE TIBIAL BASE. IT WAS ATTEMPTED FOR 45 MINUTES WITHOUT SUCCESS, THE SURGEON DECIDED NOT TO CHANGE THE IMPLANTED TIBIA TO AVOID PROLONGING THE SURGERY AND POSSIBLE COMPLICATIONS. THE PROCEDURE WAS RESUMED, AFTER A 45 MINUTES DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS STABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887822 ↗
• InjuryNov 25, 2021Break; Break

  IT WAS REPORTED THAT, DURING TKA SURGERY, A GII PS INSERT SZ 3-4 11MM WAS FOUND TO BE BROKEN DURING SURGERY. DEVICE INSIDE THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12875251 ↗
• MalfunctionMay 10, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A TKA SURGERY. THE SURGEON FIRST PERFORMED A TEST WITH FEMUR PS 5 LEFT AND GII PS INSERT SZ 3-4 11MM. THEN, THE SURGEON PROCEEDS TO PLACE THE GII PS INSERT SZ 3-4 11MM AND SLIDES IT FROM INTERIOR TO POSTERIOR AND FINALLY USES THE INSERT REDUCER TO FINISH FIXING IT, BUT THE INSERT DID NOT ENGAGED AND CLICK SO IT REMAINED RAISED 1MM. THE SURGEON REPEATED THE MANEUVER THREE TIMES, ENSURING THAT THERE WAS NOTHING THAT PREVENTS THE PROPER ASSEMBLY OF THE INSERT WITH THE TIBIAL BASE, BUT THE INSERT WAS ALWAYS RAISED BY 1MM AND DID NOT MADE THE CLICK THAT ENSURED A CORRECT ASSEMBLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DELAY LESS THAN OR EQUAL TO 30 MINUTES USING A SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803263 ↗
• MalfunctionDec 14, 2020Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING A REVISION SURGERY OF LEGION PRIMARY CR PROSTHESIS, WHEN TRYING TO EXCHANGE INLAY, A GENESIS II PS INSERT SZ 3-4 11MM WAS USED, BUT IT COULD NOT BE FIXED ON THE TIBIAL BASE. THEN, IT WAS ATTEMPTED TO ANCHOR A LEGION CON ARTICULAR INSERT 9MM SZ 3-4 AND IT ALSO FAILED. THE INLAY COULD NOT BE FIXED AND THE PROCEDURE WAS FINISHED USING THE SAME INLAY IN THE PATIENT. THIS ISSUE CAUSED A DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11001965 ↗
• MalfunctionDec 4, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING THE TKA PROCEDURE, THE GII PS INSERT SZ 3-4 11MM COULD NOT BE INSERTED. IT WAS THEN TRIED TO INSERT ANOTHER GII PS INSERT SZ 3-4 11MM, BUT IT WAS NOT POSSIBLE EITHER. A THIRD IMPLANT FROM SMITH & NEPHEW WAS USED. THE PROCEDURE HAD A DELAY OF 15 MIN. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10945454 ↗
• MalfunctionDec 2, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT, DURING THE TKA PROCEDURE, THE GII PS INSERT SZ 3-4 11MM COULD NOT BE INSERTED. IT WAS THEN TRIED TO INSERT ANOTHER GII PS INSERT SZ 3-4 11MM, BUT IT WAS NOT POSSIBLE EITHER. A THIRD IMPLANT FROM SMITH & NEPHEW WAS USED. THE PROCEDURE HAD A DELAY OF 15 MIN. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10934457 ↗
• MalfunctionOct 14, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE GII PS INSERT SZ 3-4 11MM IS NOT LOCKING PROPERLY. IT IS UNKNOWN WHEN WAS THIS MALFUNCTION DISCOVERED. THERE WAS NO DELAY AND A S&N BACK UP DEVICE WAS AVAILABLE. NO INJURIES REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10681166 ↗
• MalfunctionSep 29, 2020Defective Device; Positioning Problem; Defective Device; Positioning Problem

  IT WAS REPORTED THAT DURING A TKA SURGERY, THE PRODUCT NARROW WAS USED, AND THE INSERT 3-4 11MM COULD NOT BE PLACED. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. NO SURGICAL DELAY REPORTED. NO PATIENT HARM 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; No Known Impact Or Consequence To Patient

  MAUDE report 10604096 ↗
• MalfunctionApr 21, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY, INSERT WAS UNABLE TO BE INSERTED PROPERLY. ALTERNATIVE IMPLANTS FROM SMITH AND NEPHEW WERE USED IN THE SURGERY. DELAY OF LESS THAN 30 MINUTES, PATIENT DID NOT SUFFER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8534331 ↗
• MalfunctionDec 21, 2018Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE DEVICE INSERTED COULD NOT LOCK IN PROPERLY. BACKUP AVAILABLE. NO DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8188903 ↗
• MalfunctionOct 17, 2018Blocked Connection; Blocked Connection

  IT WAS REPORTED THAT AFTER THE TIBIAL TRAY PROSTHESIS WAS IMPLANTED, THE INSERT WAS IMPLANTED MULTIPLE TIMES AND LONG-TERM STANDARD OPERATION, IT COULD NOT BE PROPERLY LOCKED. THE INSERT AND THE TIBIAL TRAY PROSTHESIS COULD NOT BE REMOVED NORMALLY AFTER BEING LOCKED. FINALLY, TAKING A LOT OF FORCE TO REMOVE THE TIBIA AND BONE CEMENT LOOSENED AND TOOK AWAY PART OF THE BONE MASS. ALSO NEED TO RE-SELECT THE LARGER PROSTHESIS.

  Patient problems: No Information

  MAUDE report 7974357 ↗
• MalfunctionOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY THE DEFINITIVE INSERT DID NOT LOCK. DELAY OF LESS THAN 30MIN REPORTED. NO INJURY REPORTED. BACK UP AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7970343 ↗
• InjuryOct 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH A POSTERIOR DISLOCATION OF A PREVIOUSLY WELL-FUNCTIONING LEFT TOTAL KNEE REVISION. THIS WAS THOUGHT SECONDARY TO THE PATIENT'S WEIGHT OF APPROXIMATELY 150 KG. THE KNEE WAS REDUCED UNDER ANESTHESIA, POSTERIORLY THE SURGEON PROCEED TO REMOVED THE TIBIAL COMPONENT AND REPLACED IT WITH A 15 MM SIZE 3/4 GENESIS II CONSTRAINED ARTICULAR INSERT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7928416 ↗
• MalfunctionJun 26, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING SURGERY POLY WOULD NOT STAY LOCKED IN TIBIA, TRIED SEVERAL TIMES THEN OPENED ANOTHER POLY AND IT LOCKED AND STAYED IN.

  Patient problems: No Information

  MAUDE report 7640017 ↗
• InjuryJun 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNSPECIFIED REASONS. A WASHOUT WAS DONE DURING THE PROCEDURE AND THE POLY WAS ALSO EXCHANGED.

  Patient problems: Injury

  MAUDE report 7608447 ↗
• InjuryMar 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A TOTAL KNEE REPLACEMENT, THE INSERT WAS NOT ABLE TO EFFECTIVELY MOUNT ON BASEPLATE. THE SURGERY DELAYED 30 MIN AND BLEEDING INCREASED AND BLOOD TRANSFUSIONS WERE NEEDED.

  Patient problems: Injury

  MAUDE report 7325459 ↗
• InjuryDec 21, 2017Positioning Problem; Positioning Problem

  IT WAS REPORTED A SURGERY DELAY OF 30-60 MINUTES SINCE SURGEON FAILED TO IMPLANT THE INSERT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7140020 ↗
• InjuryMay 11, 2017Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING A UNILATERAL KNEE JOINT REPLACEMENT, THE INSERT COULD NOT BE LOCKED EFFECTIVELY. THE ISSUE RESULTED IN A 40 MINUTE SURGICAL DELAY. THE PATIENT'S BLOOD PRESSURE BECAME UNSTABLE AND BEGAN TO VOMIT. A DIFFERENT INSERT WAS USED TO COMPLETE THE SURGERY.

  Patient problems: Vomiting

  MAUDE report 6560674 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951987. One submission often covers many models, so check the product and lot details in each record.

• Z-1418-2022 · Jun 27, 2022 · Terminated
  (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.
• Z-2774-2020 · Jul 16, 2020 · Open, Classified
  Tibial knee prosthesis
• Z-2883-2018 · Aug 1, 2017 · Terminated
  GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
• Z-0573-2016 · Nov 9, 2015 · Terminated
  Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 kn
• Z-0130-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
• Z-0131-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic