GENESIS II 71420166Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 03596010206268), received between Apr 17, 2017 and Apr 1, 2024 — classified as 27 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 reports).

1 FDA recall record name this device's identifier.

5 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.

Recalls naming this device

1. Jun 27, 2022Terminated

   The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

   Z-1418-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT, AFTER A TKR HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT WAS DETERMINED TO REQUIRE A TIBIAL COMPONENT REVISION DUE TO OVERSIZING. EVEN THOUGH THE REVISION SURGERY HAS NOT BEEN PERFORMED YET, THE SURGEON STATED THIS PROCEDURE WILL BE SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 19016744 ↗
• MalfunctionSep 9, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT AFTER A TKA PROCEDURE HAD BEEN FINISHED, THE CUSTOMER NOTICED THAT THE LABELS DID NOT MATCH WHEN REORDERING THE OP CONSUMPTION. ACCORDING TO THE INSIDE LABEL (STICKER), A GNS II CMT TIB SIZE 4 LEFT HAS BEEN INSTALLED. THE CUSTOMER SAID THE OUTSIDE LABEL SAID JOURNEY TIBIAL COMPONENT. THE OUTER PACKAGING IS NO LONGER AVAILABLE. IT IS UNCLEAR WHICH COMPONENT WAS ACTUALLY IMPLANTED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393572 ↗
• InjuryJul 26, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKR CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT KNEE ON (B)(6) 2019, THE PATIENT EXPERIENCED PAIN, LIMITED RANGE OF MOTION, SWELLING, INSTABILITY AND DEMONSTRATED UPTAKE ON ALL 3 PHASES AS REVEALED BY A BONE SCAN ANALYSIS. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. INTRAOPERATIVELY, THE TIBIAL TRAY WAS NOTED TO HAVE SOFT TISSUE INTERPOSITION AND THE FEMORAL CONDYLE WAS ALSO NOTED TO HAVE GRANULATION INTERPOSING THE BONE IMPLANT INTERFACE, ALL CONSISTENT WITH LOOSENED PROSTHESIS. THE FEMORAL COMPONENT, TIBIAL TRAY AND THE ARTICULAR INSERT WERE EXPLANTED AND REPLACED WITH A REVISION SYSTEM. THE PATIENT WAS EVENTUALLY AWAKENED, EXTUBATED AND TRANSFERRED TO THE PACU ROOM IN STABLE CONDITION. TO DATE, PATIENT HAS CONSTANT PAIN, SWELLING, AMBULATION DIFFICULTNESS AND INSTABILITY OF HER LEG.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Failure of Implant; Joint Laxity; Pain; Swelling/ Edema

  MAUDE report 15105959 ↗
• MalfunctionMay 27, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN THE IMPLANT WAS OPENED THE GNS II CMT TIB SIZE 4 LEFT PACKAGING HAD THE WRONG ITEM IN THE BOX. INSIDE WAS A GNS II CMT TIB SIZE 5 RIGHT INSTEAD. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW GNS II CMT TIB SIZE 4 LEFT BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14520217 ↗
• MalfunctionMay 21, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THE OUTER LABEL AND CHART STICKS SHOWED ITEM 71420166 / LOT 21FM13870A WHICH CORRESPONDS TO A GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 4 LEFT, BUT THE ACTUAL IMPLANT AND THE INNER STERILE PACKAGE ARE 71420186 / 21DM14954R WHICH CORRESPONDS TO A GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 5 RIGHT. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466784 ↗
• MalfunctionMay 21, 2022No Apparent Adverse Event; Inaccurate Information; No Apparent Adverse Event; Inaccurate Information

  IT WAS REPORTED THAT, DURING A TKA SURGERY, WHEN OPENING THE PACKAGE OF A GNS II CMT TIB SIZE 4 LEFT, IT WAS FOUND THAT INSTEAD OF IT, THERE WAS A GNS II CMT TIB SIZE 5 RIGHT INSIDE. THE ISSUE WAS NOTICED BEFORE HANDING THE IMPLANT OFF TO THE NURSE. THE PROCEDURE WAS COMPLETED, WITH A NON-SIGNIFICANT DELAY, USING A GNS II CMT TIB SIZE 4 LEFT BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14466754 ↗
• InjuryFeb 8, 2022Adverse 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) 2020, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022, IN WHICH THE GNS II CMT TIB SIZE 4 LEFT WAS REMOVED AND REPLACED WITH LEGION REVISION. THE REASON FOR THE REVISION SURGERY IS UNKNOWN. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13484702 ↗
• InjuryDec 10, 2021Break; Break

  IT WAS REPORTED THAT, DURING A TKA SURGERY, TWO (2) LGN XLPE PS INSERT SZ 3-4 9MM WOULD NOT SEAT INTO THE TIBIAL GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 4 LEFT INTRAOPERATIVELY; DEEMING THE LOCKING MECHANISM OF THE GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 4 LEF BROKEN. THE GENESIS II NON-POROUS TIBIAL BASEPLATE SIZE 4 LEFT HAD TO BE EXPLANTED BY CUTTING IT OUT, BECAUSE IT WAS ALREADY CEMENTED, MORE BONE WAS TAKEN. IT TOOK TWICE AS LONG TOURNIQUET TIME AND MORE BLOOD LOSS WAS REPORTED. SURGERY WAS RESUMED, AFTER A DELAY GREATER THAN 30MINS, WITH A BACK-UP DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975732 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF LEGION PRIMARY CR PROSTHESIS WAS PERFORMED DUE TO MALROTATION FEMUR. THE GENESIS II CMT TIBIAL SIZE 4 LEFT WAS REVISED AND EXCHANGED. THE PATIENT WAS DISCHARGED FROM HOSPITAL.

  Patient problems: Failure of Implant

  MAUDE report 11001988 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. THE PATIENT HAS NEUROLOGICAL ISSUES. A REVISION SURGERY WAS PERFORMED TO EXPLANT GNS II CMT TIB SIZE 4 LEFT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Nervous System Injury

  MAUDE report 10912656 ↗
• InjuryNov 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO TIBIA BECAME LOOSE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Failure of Implant

  MAUDE report 10848159 ↗
• InjuryNov 11, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER 13 YEARS OF THE PRIMARY TKA SURGERY, THE SZ4 TIBIA BECAME LOOSE. A REVISION SURGERY TOOK PLACE TO REPLACE THE GENESIS II CMT TIB SIZE 4 LEFT. THE 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: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 10822931 ↗
• InjuryOct 23, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED A REVISION SURGERY WAS CONDUCTED BECAUSE THE PATIENT PRESENTED PAIN AND LOOSENING OF THE BASE PLATE. THE SURGEON SAYS THE DEVICES WERE NOT DEFECTIVE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 10731242 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A INFECTION. NO MORE INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 10668141 ↗
• InjuryJun 18, 2020Unstable; Use of Device Problem; Unstable; Use of Device Problem

  IT WAS REPORTED THAT DURING A KNEE ENDO-PROSTHESIS SURGERY, THE TIBIAL ELEMENT WAS NOT ATTACHED CORRECTLY. AFTER IMPLANT PLACEMENT AND WAITING FOR CEMENT SETTING TIME, THE IMPLANT WAS STILL LOOSE. AFTER TAKING OFF THE ELEMENT, THERE WERE NO VISIBLE CEMENT MARKS ON IT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED. 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 10171631 ↗
• InjurySep 15, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT WAS NOTED WITH STIFFNESS POST LEFT TKR FOR WHICH MANIPULATION UNDER ANESTHESIA WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 9058532 ↗
• InjuryAug 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE FEMUR AND STEMMED WERE REVISED, POOR BONE STOCK + OSTEOPOROSIS + OXINIUM METAL ALLERGY. BONE FROM ANTERIOR FEMUR FELL OUT AFTER TRIALLING. IMPLANTS WELL FIXED ORIENTATION ACCEPTABLE. NO MORE INFORMATION PROVIDED YET.

  Patient problems: Injury

  MAUDE report 8904434 ↗
• InjuryJun 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED ARTHROFIBROSIS IN THE LEFT KNEE. PATIENT WAS TREATED WITH A MANIPULATION UNDER ANESTHESIA. THE EVENT WAS RESOLVED.

  Patient problems: Fibrosis

  MAUDE report 8663519 ↗
• MalfunctionMay 13, 2019Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT DURING SURGERY A LEFT GENESIS II TIBIAL BASEPLATE (71420166) WAS IMPLANTED DURING A JOURNEY II TKA PROCEDURE. A J2 INSERT (74027241) WAS IMPLANTED AND LOCKED IN APPROPRIATELY TO THE GEN II TIBIAL BASEPLATE. NO DELAY WAS REPORTED AND NO BACKUP WAS NEEDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8604532 ↗
• InjuryMay 13, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENED BASEPLATE.

  Patient problems: Injury

  MAUDE report 8604088 ↗
• InjuryMar 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT PRESENTED A LEFT KNEE STIFFNESS POST TKA. ADVERSE EVENT WAS RESOLVED WITH MANIPULATION UNDER ANESTHESIA. NO DEVICE IS IDENTIFIED AS PRIMARY SOURCE OF FAILURE.

  Patient problems: Injury

  MAUDE report 8464646 ↗
• InjuryJan 15, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BASEPLATE LOOSENING. BASEPLATE AND INSERT WERE REPLACED.

  Patient problems: Injury

  MAUDE report 8248643 ↗
• InjuryJan 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO GONARTHROSYS. THE DEVICES WERE IMPLANTED IN 2017 AND EXPLANTED ON (B)(6) 2018.

  Patient problems: Injury

  MAUDE report 8214916 ↗
• InjuryNov 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL THE IMPLANTS WERE REMOVED DUE TO INFECTION CAUSED BY POST OPERATIVE TRAUMA. NO X-RAYS AVAILABLE, IMPLANTS UNABLE TO BE RECOVERED. ALSO THE SURGEON DOES NOT BLAME THE IMPLANTS FOR THE SITUATION.

  Patient problems: Unspecified Infection

  MAUDE report 8098828 ↗
• InjurySep 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY HAS BEEN PERFORMED DUE TO A SEPTIC ARTHRITIS DEVELOPMENT. AN INCISION AND DRAINAGE WITH IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON THE LEFT KNEE.

  Patient problems: Injury

  MAUDE report 7921366 ↗

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-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