GENESIS II 71420558Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010208217), received between Oct 1, 2018 and Jan 20, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT UNDERWENT A RIGHT TKA REVISION DUE TO ASEPTIC LOOSENING AS PRIMARY DIAGNOSIS WITH BEARING WEAR AND PATELLA MALTRACKING OR INSTABILITY AS SECONDARY DIAGNOSES. APPROXIMATELY NINETY EIGHT (98) MONTHS AFTER THIS PROCEDURE, THE PATIENT EXPERIENCED INSTABILITY OF THE REVISED KNEE PROSTHESIS AND REQUIRED A SECOND REVISION. THE DATES IN WHICH THE INDEX SURGERY, FIRST REVISION AND SECOND REVISION TOOK PLACE ARE NOT KNOWN. IT IS ALSO UNKNOWN WHICH DEVICES WERE EXPLANTED AND/OR EXCHANGED DURING THE SECOND REVISION. THIS INCIDENT WAS IDENTIFIED IN A RETROSPECTIVE POST-MARKET CLINICAL FOLLOW UP ACTIVITY (PMCF) WHERE ANONYMIZED DATA SUMMARIZING TKA REVISION OUTCOMES WERE GATHERED; THEREFORE, ADDITIONAL INFORMATION IS NOT KNOWN.

  Patient problems: Joint Laxity

  MAUDE report 16216023 ↗
• InjuryOct 2, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO SEVERE ARTHROFIBROSIS, LIMITATION OF MOTION, FAILURE OF ANTERIOR LOCKING COMPONENT OF THE TIBIAL INSERT.

  Patient problems: Fibrosis

  MAUDE report 7929016 ↗
• InjuryOct 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT INCISION, DEBRIDEMENT AND PLACEMENT WOUND WERE PERFORMED. IT WAS FOUND TO HAVE APPROXIMATELY A 4CM DEHISCENCE OF THE VERY INFERIOR PORTION OF THE WOUND. THERE WAS A CONCERN THAT THE PATELLAR TENDON MAY WELL BE EXPOSED.

  Patient problems: Abrasion

  MAUDE report 7924140 ↗

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