GENESIS II 71421038Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 03596010485083), received between Oct 25, 2017 and Nov 19, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA HAS BEEN PERFORMED ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH THE GII OXIN P/S FEM RIGHT SIZ 8, GII PS HI FLEX ISRT SZ 7-8 13, GEN II MIS TIB BASE CEM SZ8 RT AND GII OVAL RESURFACING PAT 38MM WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12848126 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TKR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED ACUTE INFECTION OF LEFT KNEE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. THE DR. CONDUCTED AN OPEN WASHOUT AND DEBRIDEMENT WITH INSERT AND PATELLA REVISION. TISSUE SAMPLES WERE SENT TO PATHOLOGY. THE WOUND IRRIGATED WITH BETADINE AND SALINE AND CLOSED AS PER STANDARD TECHNIQUE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 12639797 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN AND SWELLING FROM INFECTION. A PREVIOUS WASHOUT AND INSERT EXCHANGE WAS PERFORMED ON (B)(6) 2021. AFTER THIS PROCEDURE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. THE JRNY II BCS FEMORAL OXIN LT SZ 8, JOURNEY TIBIA BASE NP LT SZ 6, JRNY II BCS CNSTRD ART ISRT 5-6 LT 11M AND GII OVAL RESURFACING PAT 38MM WERE EXPLANTED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 11880504 ↗
• InjuryNov 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY PATIENT HAD PERONEAL VEIN THROMBOSIS AND CELLULITIS IN LEFT KNEE. MEDICATION THERAPY WAS USED TO RESOLVE THE EVENT.

  Patient problems: Pain

  MAUDE report 9315151 ↗
• InjuryAug 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED RIGHT TIBIAL SPINE FRACTURE AND ACL DEFICIENCY POST OPERATIVE.

  Patient problems: Injury

  MAUDE report 8881973 ↗
• InjuryJul 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A RIGHT KNEE INFECTION. ALL IMPLANTS WERE REMOVED AND AN ANTIBIOTIC CEMENT SPACER WAS INSERTED.

  Patient problems: Unspecified Infection

  MAUDE report 8844588 ↗
• InjuryJan 31, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A RIGHT KNEE MANIPULATION WAS PERFORMED DUE TO THE PATIENT PRESENTED LIMITED RANGE OF MOTION.

  Patient problems: Injury

  MAUDE report 8292195 ↗
• InjuryDec 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A MEDICAL INTERVENTION WAS PERFORMED. PATELLA WAS RESURFACED DUE TO ANTERIOR BASE LEFT KNEE PAIN.

  Patient problems: Pain

  MAUDE report 8146104 ↗
• InjuryAug 24, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY OF THE RIGHT KNEE WAS PERFORMED TO REVISE THE PATELLAR COMPONENT DUE TO PAIN. DURING THE REVISION THE DOCTOR FIND ABUNDANT SYNOVITIS, SIGNIFICANT SCARRING OF THE INFRAPATELLAR FAT PAD. PATIENT WITH LONG MEDICAL HISTORY.

  Patient problems: Pain

  MAUDE report 7814660 ↗
• InjuryAug 23, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY AND MANIPULATION DUE TO: PAIN, STIFFNESS, MECHANICAL SYMPTOMS AND DYSTROPHIC SCAR TISSUE.

  Patient problems: No Code Available

  MAUDE report 7811387 ↗
• InjuryOct 25, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED A REVISION OF THE RIGHT PATELLAR COMPONENT WAS PERFORMED DUE TO DISASSOCIATION.

  Patient problems: Joint Dislocation

  MAUDE report 6975474 ↗

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