GENESIS II 71420162Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010206244), received between Sep 20, 2017 and Nov 7, 2019 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TKR WAS PERFORMED ON THE LEFT 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 9293538 ↗
• InjuryMay 8, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO SEPTIC MOBILIZATION OF THE PROSTHESIS.

  Patient problems: Injury

  MAUDE report 8591282 ↗
• InjuryApr 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT LEFT KNEE REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE TIBIA COMPONENT.

  Patient problems: Injury

  MAUDE report 8547007 ↗
• InjuryOct 3, 2018Naturally Worn; Protective Measures Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SEVERE WEAR AND METAL DEBRIS NOTED ON X-RAYS.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7931201 ↗
• InjuryOct 1, 2018Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

  Patient problems: No Information; Pain

  MAUDE report 7924190 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED. MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION WITH SEMITENDINOSUS ALLOGRAFT LEFT KNEE AND APPLICATION OF LONG LEG IMMOBILIZER. NO IMPLANTS REMOVED.

  Patient problems: Injury

  MAUDE report 7923430 ↗
• InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem

  REVISED A TKA FROM (B)(6) 2006. THE SURGEON DOES NOT FAULT THE DEVICES.

  Patient problems: Injury; No Code Available

  MAUDE report 6881510 ↗

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