GENESIS II 71926226Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010587596), received between Dec 6, 2018 and Aug 11, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAD BEEN PERFORMED IN 2019, THE PATIENT EXPERIENCED DAMAGED OF PATELLA IMPLANT BECAUSE OF AN ACCIDENT. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2022, TO EXCHANGE THE GEN II RESURF PATELLA 41MM. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 15211415 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TOTAL KNEE REVISION SURGERY WAS PERFORMED BECAUSE THE POLY AND PATELLA IMPLANT FAILED FROM A PREVIOUS TOTAL KNEE SURGERY. MEDWATCH USER REPORT MW5093972.

  Patient problems: Injury

  MAUDE report 10077378 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PRESENTED THE FOLLOWING SYMPTOMS POST OPERATIVELY: RIGHT POPLITEAL TENDONITIS; RIGHT POSTEROLATERAL KNEE SOFT TISSUE IMPINGEMENT. IT WAS RESOLVED WITH UNSPECIFIED SURGICAL PROCEDURE.

  Patient problems: Injury

  MAUDE report 8897952 ↗
• InjuryAug 12, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED A PATELLA REVISION SURGERY DUE TO LOOSENING. THE PATIENT INJURED HIS CONTRALATERAL LEG 6 MONTHS AGO, WHICH LED HIM TO HAVE TO LIMP AROUND, WHICH IN TURN MADE HIS TKR VERY PAINFUL. UPON OPENING UP THE JOINT, IT WAS DISCOVERED THAT THE PATELLA COMPONENT WAS LOOSE, MISSHAPEN AND ONE OF THE FIXATION PEGS HAD BROKEN OFF. DR BELIEVES THAT DUE TO HIS CHANGE IN GAIT AFTER HIS INJURY TO THE OTHER LEG, ABNORMAL FORCES WERE PUT INTO THE PATELLA COMPONENT, LOOSENING AND DAMAGING IT.

  Patient problems: Injury

  MAUDE report 8883000 ↗
• InjuryJun 24, 2019Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF FEMORAL COMPONENT, PATELLA AND TIBIAL BASEPLATE.

  Patient problems: Injury

  MAUDE report 8727648 ↗
• InjuryMay 14, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PATIENT HAD A BILATERAL ARTHROSOPY WITH SYNOVECTOMY AND LATERAL RELEASE.

  Patient problems: Injury

  MAUDE report 8610535 ↗
• InjuryMay 14, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PATIENT HAD A BILATERAL ARTHROSOPY WITH SYNOVECTOMY AND LATERAL RELEASE.

  Patient problems: Injury

  MAUDE report 8610534 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN THE PATIENT DUE TO PAIN AND SWELLING. NO DELAY REPORTED. IMPLANTS REPLACED WITH COMPETITOR DEVICES.

  Patient problems: Injury

  MAUDE report 8137819 ↗
• InjuryDec 6, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED IN THE PATIENT DUE TO PAIN AND SWELLING. NO DELAY REPORTED. IMPLANTS REPLACED WITH COMPETITOR DEVICES.

  Patient problems: Injury

  MAUDE report 8137733 ↗

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