GENESIS II 71420006Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010205445), received between Aug 3, 2020 and Jul 13, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Biocompatibility” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 13, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, DURING A FOLLOW UP EXAMINATION 2 YEARS AFTER A TKA SURGERY, THE PATIENT WAS DIAGNOSED WITH METAL ALLERGY; THE CONDITION HAD BEEN ONGOING FOR THE LAST YEAR. TO COUNTER THIS ADVERSE CONDITION MEDICATION WAS PRESCRIBED ON (B)(6)2023. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17322416 ↗
• InjuryMay 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA REVISION SURGERY PERFORMED ON (B)(6) 2019 TO EXCHANGE THE PATELLAR AND POLYETHYLENE INSERT COMPONENTS, THE PATIENT CONTINUED TO EXPERIENCE CHRONIC PAIN, WEAKNESS, LIMITATIONS WITH MOBILITY AND DECREASED ROM. X-RAY EVALUATION SHOWED IMPLANTS IN GOOD ALIGNMENT WITH NO EVIDENCE OF LOOSENING, MALALIGNMENT, OR PROBLEM. ALTHOUGH MEDICATED WITH TYLENOL AND MELOXICAM AND AFTER COMPLETING A PHYSIOTHERAPY PLAN WITHOUT SUCCESS, THE SURGEON RESPONSIBLE FOR THE REVISION SURGERY ON (B)(6) 2019 RECOMMENDED A THIRD INTERVENTION OF THE LEFT KNEE, BUT THE PATIENT HAS DECLINED IT. THE PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Loss of Range of Motion

  MAUDE report 14466765 ↗
• InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PLAINTIFF UNDERWENT MEDICALLY-INDICATED REVISION SURGERY OF THE LEFT KNEE ON (B)(6) 2019 DUE TO CHRONIC PAIN, WHICH THE PATIENT PRESENTED SINCE (B)(6) 2017. DURING THIS PROCEDURE, THE PATELLAR COMPONENT AND THE INSERT WERE EXCHANGED. THE PRIMARY TKR WAS PERFORMED ON (B)(6) 2014. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12595365 ↗
• MalfunctionAug 3, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE IMPLANT COULD NOT BE REMOVED FROM THE PACKAGING BECAUSE IT WAS FUSED TO THE PACKAGING. THIS WAS NOTICED DIRECTLY WHEN OPENING THE PACKAGING. NO SURGERY TIME DELAY. IMPLANT WAS NOT USED AND A S+N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACT. THIS EVENT WAS CONSERVATIVELY REPORTED SINCE COMPLICATIONS DURING TREATMENT HAVE BEEN REPORTED IN THE PAST FOR THIS FAILURE MODE, SUCH AS USE OF AN ALTERNATIVE DEVICE TO COMPLETE THE PROCEDURE, BUT NO PATIENT HARM HAS BEEN REPORTED. THIS ALTERNATIVE TREATMENT IS CONSIDERED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR BODY FUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 10355609 ↗

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