GENESIS II 71420848Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010209733), received between Jun 28, 2018 and Jul 11, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2004, THE PATIENT EXPERIENCED BROKEN POST ON GII PS INSERT SZ 7-8 13MM. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE IMPLANT WAS EXCHANGED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19721706 ↗
• InjuryJun 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAS A TIBIAL FRACTURE AND AN INFECTION WAS ALSO CONFIRMED. THEREFORE A REVISION SURGERY WAS PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 8663099 ↗
• InjuryNov 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD OCCASIONAL CLICKING AND POPPING WHILE WALKING. DOCTOR SUGGESTED A CONSTRAINED KNEE REVISION AND SYNOVECTOMY SINCE IMPLANTS APPEAR TO BE WELL FIXED AND ALIGNED BUT THERE ARE SOME SUBTLE RADIOLUCENCIES AROUND CEMENTLESS STEMS. A CONSTRAINED POLYETHYLENE AVAILABLE WAS REQUESTED BY THE DOCTOR FOR THE REVISION SURGERY AND POTENTIALLY REVISION IMPLANTS, ALTHOUGH UNLIKELY TO BE NEEDED. INFORMATION ABOUT REVISION SURGERY HASN'T BEEN RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8036268 ↗
• InjuryOct 2, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT (B)(6) WAS DIAGNOSED WITH LOOSENING OF RIGHT TOTAL KNEE ARTHROPLASTY AFTER TKA IN 2012 AND POST RESURFACING OF THE PATELLA PLUS INCREASE IN THE THICKNESS OF THE POLY INSERT TO 13MM IN 2014. A REVISION SURGERY WAS PERFORMED AND THE TIBIAL BASEPLATE, FEMORAL COMPONENT AND THE POLY INSERT WERE REPLACED.

  Patient problems: Injury

  MAUDE report 7928554 ↗
• InjuryJun 28, 2018Break; Break

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED AFTER 10 YEARS BECAUSE OF A BROKEN POST.

  Patient problems: Injury

  MAUDE report 7644681 ↗

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