GENESIS II 71932635Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00885556056516), received between Apr 18, 2018 and Jun 2, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Fracture” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2024, THE PATIENT EXPERIENCED A DISLOCATION OF THE PATELLA. THIS ADVERSE EVENT WAS SOLVED BY AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) ON (B)(6) 2024, IN WHICH ALL OF THE IMPLANTS REMAINED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25367699 ↗
• InjuryApr 23, 2024Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON AN UNSPECIFIED DATE, THE GEN II 7.5MM RESUR PAT 29MM CAME OFF IN PATIENT. THIS INCIDENT WAS SOLVED PERFORMING A REVISION SURGERY ON (B)(6) 2024, IN WHICH THE GEN II 7.5MM RESUR PAT 29MM WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 19164693 ↗
• InjuryOct 7, 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) 2016, THE CLINICAL SUBJECT EXPERIENCED AN UNSPECIFIED ADVERSE EVENT. HOWEVER, IT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2019. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12595348 ↗
• InjuryJun 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL KNEE ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS SOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2021. THE REPORTED DEVICES WERE A JOURNEY II BCS XLPE ARTICULAR INSERT SIZE 3-4 LT 9MM, A JOURNEY TIBIA BASE NP LT SIZE 3 , A GENESIS II 7.5MM RESUR PATELLA 29MM AND A JRNY II BCS FEM COCR LT SZ 4. THE SURGEON STATED THE DEVICES WERE NOT DEFECTIVE.

  Patient problems: Unspecified Infection

  MAUDE report 12017303 ↗
• InjuryNov 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD IMPLANTATION ON (B)(6) 2020. SINCE SEPTEMBER, THE PATELLA OF THE PATIENT HAS GONE THINNER GRADUALLY. THEREFORE, ON (B)(6) A BONE FRACTURE (PATELLA) WAS FOUND. THE PATIENT DID NOT HAVE TRAUMATIC EVENTS AND RHEUMATOID ARTHRITIS. REVISION SURGERY IS NOT SCHEDULED.

  Patient problems: Bone Fracture(s)

  MAUDE report 10912996 ↗
• InjuryFeb 26, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO PAIN AND IMPLANT FRACTURE. THE IMPLANTED INSERT WAS THE ONLY DEVICE REVISED.

  Patient problems: Injury

  MAUDE report 9757100 ↗
• InjuryFeb 6, 2020Material Separation; Material Separation

  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 WAS PERFORMED ON (B)(6) 2020, WHERE THE PATELLA AND INSERT WERE REVISED.

  Patient problems: Injury

  MAUDE report 9676189 ↗
• InjuryJan 10, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Joint Dislocation

  MAUDE report 9577202 ↗
• InjuryMar 18, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED DUE TO DEFORM, FRACTURE, OSTEOLYSIS AND DISLOCATION OF PATELLA. THE PATELLAR COMPONENT WAS REMOVED.

  Patient problems: Injury

  MAUDE report 8430646 ↗
• InjuryFeb 21, 2019Fracture; Fracture

  IT WAS REPORTED THAT AFTER PROCEDURE, THE PATIENT'S PATELLA FRACTURED DURING REHABILITATION. ADVERSE EVENT TREATED WITH A CAST, NO PROCEDURE HAS BEEN SCHEDULED.

  Patient problems: Bone Fracture(s)

  MAUDE report 8359911 ↗
• InjuryOct 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. THE AFFECTED KNEE WAS IRRIGATED. COMPONENT WAS REMAINED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7931735 ↗
• InjuryJul 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT HAD A MANIPULATION UNDER ANESTHESIA DUE TO ARTHROFIBROSIS

  Patient problems: Injury

  MAUDE report 7684028 ↗
• InjuryApr 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS TOLD BY HER DOCTOR THAT A SURGICAL INTERVENTION COULD BE PERFORMED IN THE FUTURE.

  Patient problems: No Information; Pain

  MAUDE report 7441659 ↗

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