GENESIS II 71420180Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010206329), received between Feb 8, 2018 and Dec 15, 2021 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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.

• InjuryDec 15, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED RIGHT KNEE PAIN AND EFFUSION. THIS ADVERSE EVENT WAS TREATED BY DOING A WOUND DEBRIDEMENT ON (B)(6) 2021. DURING THE SAID PROCEDURE, THE SURGEON FOUND SIGNS OF METALLOSIS. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO METALLOSIS AND IMPLANT LOOSENING. DURING THIS PROCEDURE, THE FEMORAL COMPONENT, INSERT AND TIBIAL COMPONENT WERE EXPLANTED FROM THE PATIENT. CURRENTLY THE PATIENT CONDITION IS STABLE AFTER REVISION SURGERY AND IS IN THE PROCESS OF RECOVERY.

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 13010595 ↗
• InjuryJul 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED ON (B)(6) 2019, THE PATIENT WAS REVISED ON (B)(6) 2021 BECAUSE THE LOCKING MECHANISM OF THE TIBIAL BASEPLATE WAS NOT WORKING AND THE POLY WAS NOT LOCKING. THIS WAS THE SECOND REVISION SURGERY PERFORMED TO THIS PATIENT, THE FIRST REVISION WAS PERFORMED ON (B)(6) 2021 FOR POLY BREAKAGE ((B)(4)). NO SURGICAL DELAY WAS REPORTED. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12111910 ↗
• InjuryDec 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY OF GEN II WAS PERFORMED DUE TO AN UNSPECIFIED REASON. 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 11018594 ↗
• InjuryDec 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION.

  Patient problems: Injury

  MAUDE report 9527943 ↗
• InjuryNov 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO THE INFECTION AND LOOSENING. PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 AND GII FEM COMPONENT(71420052), GII TIB BASE (71420180), LEGION INSERT (71453202), PATELLA (71420580). ALL OF THE IMPLANTED DEVICES WERE REVISED. THE REVISED DEVICES WILL NOT BE RETURNED. THE DOCTOR DOES NOT CONSIDER AS THE FAILURE OF DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 9356854 ↗
• InjuryNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TKR WAS PERFORMED ON THE RIGHT KNEE LAST (B)(6) 2018. THE PATIENT IS IN PAIN AND SWELLING. SHE IS NOT ABLE TO WALK. X-RAYS AND TESTS ATTACHED

  Patient problems: Pain

  MAUDE report 9293541 ↗
• MalfunctionJan 29, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING SURGERY A WRONG IMPLANT WAS FOUND. THE RIGHT SIDE SIZE 2 TIBIAL BASE PLATE WAS OPENED IN THE SURGERY FOR IMPLANTING AND THE SCRUB GUY FOUND OUT THAT THE BOX CONTAINED ANTHEM SIZE 2 TIBIAL BASE PLATE. THE DOCTOR IMPLANTED THE SAME IN THE PATIENT AS THERE WAS NO BACK UP AVAILABLE. IN GENESIS II TIBIAL IMPLANT BOX, ANTHEM TIBIAL IMPLANT WAS FOUND WITH STICKERS. NO DELAY WAS REPORTED. ANTHEM AND GENESIS SETS WERE COMBINED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8285709 ↗
• InjuryDec 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED A REVISION SURGERY DUE TO DISSOCIATION OF INSERT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8126411 ↗
• InjuryNov 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED. THE TIBIA HAD TO BE REMOVED.

  Patient problems: Injury

  MAUDE report 8092364 ↗
• InjuryJul 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AT TIME OF PRIMARY SURGERY, THE PATIENT WENT TO GREAT LENGTHS VIA DIET AND MEDICATION TO GAIN CONTROL OVER DIABETES. SINCE THIS TIME THE PATIENT HAS REGRESSED TO NOW BE A POORLY CONTROLLED DIABETIC. THE PATIENT HAS HAD RECURRENT CHEST INFECTIONS TREATED WITH ANTIBIOTICS. RECENTLY DEVELOPED SYMPTOMS OF INFECTED KNEE. ALL IMPLANTS WERE REMOVED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7703263 ↗
• InjuryFeb 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO GONARTHROSIS AND INSTABILITY IN KNEE.

  Patient problems: Injury

  MAUDE report 7251886 ↗

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