GENESIS II 71932636Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00885556056721), received between Nov 2, 2017 and Mar 11, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED THE DISSOCIATION OF THE PATELLA COMPONENT AND PAIN. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE PATELLA COMPONENT WAS EXPLANTED. THE PATELLA WAS SHAPED AND THE SURGERY WAS COMPLETED WITHOUT PATELLA COMPONENT REPLACEMENT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 24568370 ↗
• InjuryJan 21, 2026Migration

  IT WAS REPORTED THAT, AFTER THE TKA PRIMARY SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED OSTEOLYSIS, THINNING, AND COLLAPSE OF THE GEN II 7.5MM RESUR PAT 32MM REVEALED BY X-RAY IMAGES. A REVISION SURGERY HAS BEEN SCHEDULED TO EXCHANGE THE PATELLA COMPONENT AND THE INSERT ON (B)(6) 2026. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Osteolysis

  MAUDE report 24132931 ↗
• InjurySep 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA PERFORMED ON (B)(6) 2020, THE PATIENT FELL AND PRESENTED PAIN AND PATELLA DISLOCATION. THIS WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2022 WHERE THE PATELLA AND LINER WERE EXPLANTED AND CHANGED TO OTHER S+N IMPLANTS. THE SURGEON DECIDED IT IS NOT A PRODUCT FAILURE. FURTHER INFORMATION IS UNKNOWN AND WILL NOT BE AVAILABLE.

  Patient problems: Fall; Joint Dislocation; Pain

  MAUDE report 15424538 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A TKA, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 DUE TO AN INFECTION AND SWELLING. THE DOCTOR SAYS THE DEVICES WERE NOT DEFECTIVE. NO HARM BEYOND DESCRIBE EVENT.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 13195197 ↗
• InjuryAug 13, 2021Material Erosion; Material Erosion

  IT WAS REPORTED THAT, AFTER PFJ RECONSTRUCTION SURGERY HAD BEEN PERFORMED ON (B)(6) 2016, THE PATIENT EXPERIENCED PAIN IN THE RIGHT KNEE AFTER A FALL. THIS ADVERSE EVENT WAS SOLVED BY CONVERTING TO TKR ON (B)(6) 2021. IT WAS NOTICED THAT THE JOURNEY PF IMPLANT MED RT WAS CRACKED AND THE GEN II 7.5 MM RESUR PAT 32 MM WAS ERODED. PATIENT LEFT SURGERY IN GOOD HEALTH.

  Patient problems: Arthralgia; Failure of Implant

  MAUDE report 12320869 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT CAME TO THE HOSPITAL DUE TO PAIN. AN X-RAY WAS PERFORMED WHERE IT WAS OBSERVED THE PATELLA COMPONENT WAS DISASSOCIATED. THEREFORE, REVISION SURGERY WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Injury; Pain

  MAUDE report 10819675 ↗
• InjuryJan 10, 2020Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  IT WAS REPORTED THAT PATELLA FRACTURE, LOOSENING OF PATELLA COMPONENT, AND DISLOCATION WERE DIAGNOSED. ON (B)(6) 2019, THE INITIAL SURGERY WAS PERFORMED. ON AN UNKNOWN DATE, THE PATELLA WAS FRACTURED. AND THE PATELLA COMPONENT WAS LOOSE AND DISASSOCIATED. REVISION SURGERY WILL BE PERFORMED ON (B)(6) 2020. AFTER SURGERY, THE COMPONENT WILL BE RETURNED.

  Patient problems: Joint Dislocation

  MAUDE report 9577165 ↗
• InjuryDec 27, 2019Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATELLA AND INSERT WERE REMOVED DUE TO THE PATELLA BEING LOOSE AFTER A FALL. POLY WAS EXCHANGED BUT NO PROBLEMS WERE ASSOCIATED WITH THE DEVICE.

  Patient problems: Injury

  MAUDE report 9526018 ↗
• InjuryAug 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED PATELLOFEMORAL CREPITATION POSTOPERATIVE. THE EVENT WAS RESOLVED PERFORMING AN UNSPECIFIED SURGICAL PROCEDURE AND HOSPITALIZATION.

  Patient problems: Injury

  MAUDE report 8897982 ↗
• InjuryJul 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AFTER SURGERY PATIENT HAD RIGHT KNEE TOTAL ANKYLOSIS AND WAS RESOLVED THROUGH HOSPITALIZATION AND A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Injury

  MAUDE report 8834592 ↗
• InjuryJul 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO RIGHT TOTAL KNEE ANKYLOSIS.

  Patient problems: Injury

  MAUDE report 8830531 ↗
• InjuryJun 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 8746888 ↗
• InjuryApr 17, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PATIENT PRESENTED EXCESSIVE ARTHROFIBROSIS OF RIGHT KNEE RESULTING IN SEVERE LIMITED RANGE OF MOTION AND DEVELOPMENT OF SCAR TISSUE RESULTING IN A CLOSED MANIPULATION.

  Patient problems: Injury

  MAUDE report 8525396 ↗
• InjuryDec 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT (B)(6) PRESENTED LEFT KNEE ANKYLOSIS RELATED TO JOURNEY II BCS RETRO IMPLANTS. EVENT WAS TREATED WITH A MANIPULATION UNDER ANESTHESIA.

  Patient problems: Muscular Rigidity

  MAUDE report 8133152 ↗
• InjuryNov 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO RIGHT KNEE ANKYLOSIS.

  Patient problems: Muscular Rigidity

  MAUDE report 8077505 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A LOCAL ANTISEPTIC INJECTION OF LIDOCAINE AND MARCAINE AND A JOINT ASPIRATION WAS REQUIRED DUE TO POSTOPERATIVE INCREASING PAIN.

  Patient problems: Pain

  MAUDE report 7164285 ↗
• InjuryJan 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO AN INFECTION, ALSO HOSPITALIZATION WAS REQUIRED.

  Patient problems: Unspecified Infection

  MAUDE report 7160937 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT NEEDED REVISION SURGERY DUE TO ARTHROFIBROSIS.

  Patient problems: Injury

  MAUDE report 7070748 ↗
• InjuryNov 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT HAS UNDERGONE MULTIPLE MANIPULATIONS UNDER ANESTHESIA DUE TO PAIN.

  Patient problems: Pain

  MAUDE report 6997820 ↗

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