GENESIS II 71420526Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010208057), received between Nov 26, 2018 and Jun 5, 2023 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A LEGION REVISION TKA SURGERY ON (B)(6) 2023 IT WAS IMPLANTED A LEGION TIBIAL BASE PLATE. WHEN SURGEON WAS ATTEMPTING TO INSERT THE 3-4 13MM CONSTRAINED POLY IT WOULD NOT LOCK DOWN. PROCEDURE WAS COMPLETED USING AN S+N BACKUP DEVICE WITHOUT SIGNIFICANT DELAYS, ALTHOUGH ADDITIONAL ANESTHESIA WAS REQUIRED. THE PATIENT WAS NOT HARMED BEYOND THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060774 ↗
• MalfunctionApr 23, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, THE GNS II CON INS SZ3-4 13MM COULD NOT BE SEATED IN THE RIGHT PLACE. THE PROCEDURE WAS COMPLETED USING A S+N BACK-UP DEVICE. IT IS UNKNOWN IF SURGERY WAS DELAYED NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716047 ↗
• MalfunctionApr 11, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT, DURING TKA SURGERY THE SURGEON ATTEMPTED TO IMPLANT THE GNS II CON INS SZ3-4 13MM AND WAS UNABLE TO GET IT TO SEAT IN THE TIBIAL BASE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11646943 ↗
• InjuryApr 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TKA REVISION SURGERY WAS PERFORMED DUE TO PATIENT PRESENTED WITH DISLOCATED KNEE. THE GENESIS II CONSTRAINED INSERT SIZE 3-4 13MM WAS EXPLANTED. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11612108 ↗
• InjuryDec 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKA SURGERY WITH GENESIS II CON INS SIZE 3-4 13MM, THE KNEE WAS INFECTED AND A NEW SMITH AND NEPHEW BACKUP DEVICE WAS IMPLANTED. PATIENT OUTCOME IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Post Operative Wound Infection

  MAUDE report 10958367 ↗
• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A KNEE REVISION WAS PERFORMED DUE INSTABILITY, RESULTING IN A REPLACEMENT OF THE ORIGINAL IMPLANT.

  Patient problems: Injury; No Code Available

  MAUDE report 10604349 ↗
• MalfunctionJul 16, 2020Difficult to Insert; Defective Device; Difficult to Insert; Defective Device

  IT WAS REPORTED THAT DURING A LEGION REVISION TKA SURGERY IT WAS IMPLANTED A LEGION TIBIAL BASE PLATE. WHEN SURGEON WAS ATTEMPTING TO INSERT THE 3-4 13MM CONSTRAINED POLY IT WOULD NOT LOCK DOWN. A SECOND HIGH FLEX LEGION POLY WAS OPENED AND ATTEMPTED TO BE INSERTED IN AND WOULD NOT LOCK IN AS WELL. EACH POLY WAS INSERTED MULTIPLE TIMES AND POPPED OUT WITH A INSTRUMENT WITH MINIMUM ANTERIOR PRESSURE. IT WAS THEN DECIDED AFTER SEVERAL ATTEMPTS TO LEAVE THE CONSTRAINED INSERT IN DUE TO THE TIBIAL BASEPLATE BEING CEMENTED. KNEE SEEMED STABLE WITHOUT THE POLY MOVING. A DELAY GREATER THAN 30 MIN WAS 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 10286063 ↗
• InjuryAug 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. WASHOUT WAS REQUIRED AND THE INSERT WAS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 8864199 ↗
• InjuryJun 16, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A REVISION SURGERY HAD TO BE PERFORMED ON THE PATIENT TO EXCHANGE LINER'S SIZE. NO DELAY SPECIFIED. NO INJURY REPORTED.

  Patient problems: Injury

  MAUDE report 8702651 ↗
• InjuryFeb 11, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE POLY HAS TO BE EXCHANGED FOR A THICKER ONE. A REVISION KNEE WAS PERFORMED APPROXIMATELY 2 YEARS AGO. IT HAS TO BE REPLACED WITH CONSTRAINED 15 MM INSERT.

  Patient problems: Injury

  MAUDE report 8329406 ↗
• InjuryNov 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

  Patient problems: Injury

  MAUDE report 8102414 ↗

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-0131-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
• Z-0130-2014 · Oct 7, 2013 · Terminated
  GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic