GENESIS II 71932637Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00885556057117), received between Nov 16, 2017 and Feb 20, 2026 — classified as 23 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (5 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 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER LEFT TKA SURGERY HAD BEEN PERFORMED WITH JOURNEY II CR ON (B)(6) 2016, THE CLINICAL SUBJECT EXPERIENCED A FAILURE OF THE GEN II 7.5MM RESUR PAT 35MM. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2022. THE ADVERSE EVENT WAS RESOLVED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 24405029 ↗
• InjuryJan 20, 2026Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2025, THE PATIENT EXPERIENCED A DISASSOCIATION OF THE GEN II 7.5MM RESUR PAT 35MM. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY PERFORMED ON (B)(6) 2025, IN WHICH THE IMPLANT WAS EXCHANGED WITH AN S+N DEVICE. THE SURGEON DOESN'T THINK PRODUCT FAILURE BECAUSE THIS EVENT WAS CAUSED BY POOR IMPLANT POSITION. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Laxity

  MAUDE report 24126056 ↗
• InjuryFeb 24, 2025Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth; Loss of Osseointegration; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT AFTER A TKA THAT TOOK PLACE ON (B)(6) 2022, A GEN II 7.5MM RESUR PAT 35MM BECAME LOOSE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO REMOVE THE GEN II 7.5MM RESUR PAT 35MM AND EXCHANGE THE JRNY II ISRT XLPE DD LT SZ 5-6 9MM. CURRENT PATIENT CONDITION IS UNKNOWN.

  Patient problems: Aseptic loosening

  MAUDE report 21446419 ↗
• InjuryJan 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER PRIMARY TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED DISASSOCIATION OF PATELLA COMPONENT, PAIN AND DISCOMFORT. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH DURING SURGERY, IT WAS FOUND THAT THE GEN II 7.5MM RESUR PAT 35MM WAS NOT FIXED, AND THE RING WAS STUCK IN THE PATELLAR TENDON. THE PATELLA COMPONENT WAS EXCHANGED TO BICONVEX PATELLA. THE OTHER IMPLANTS REMAINED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Discomfort; Joint Dislocation; Pain

  MAUDE report 21061724 ↗
• InjuryMay 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT, AFTER A TKA SURGERY WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED PAIN, FEELING OF WRONGNESS, PATELLA COLLAPSE (ON (B)(6) 2022) AND PATELLAR FRACTURE (ON (B)(6) 2022). THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, IN WHICH A GEN II 7.5MM RESUR PAT 35MM WAS EXPLANTED AND A JRNY II CR ISRT XLPE RT SZ 7-8 9MM WAS EXCHANGED. FURTHERMORE, THE INSERT WAS EXCHANGED TO REDUCE PRESSURE ON THE PATELLA. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Arthralgia; Failure of Implant

  MAUDE report 16947562 ↗
• InjuryMar 28, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA WAS PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED LOOSENING OF THE PATELLA LEADING TO A REVISION SURGERY ON (B)(6) 2023 IN WHICH THE GEN II 7.5MM RESUR PAT 35MM WAS EXPLANTED. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16632835 ↗
• MalfunctionNov 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A TKA SURGERY, WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE METAL RING WAS DISASSEMBLED FROM THE GEN II 7.5MM RESUR PAT 35MM. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15786286 ↗
• InjurySep 30, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKA SURGERY PERFORMED ON (B)(6) 2021, PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022 DUE TO LOOSENING OF THE GEN II 7.5MM RESUR PAT 35MM. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15519197 ↗
• InjuryMar 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  *US LEGAL* IT WAS REPORTED THAT AFTER A BILATERAL TKA ON (B)(6) 2016, THE PLAINTIFF PRESENTED WITH INCREASED LATERAL PATELLAR TILT AND SUBLUXATION WITH MEDIAL HETEROTOPIC BONE FORMATION AND APPARENT PATELLAR MALTRACKING IN THE RIGHT SIDE. IT IS UNKNOWN HOW OR IF THIS EVENT HAS BEEN TREATED WITH OR RESOLVED. THE OUTCOME OF THE PLAINTIFFS IS UNKNOWN.

  Patient problems: Deformity/ Disfigurement; Extraskeletal ossification; Failure of Implant; Pain; Subluxation

  MAUDE report 13815222 ↗
• InjuryFeb 1, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT, AFTER A REVISION SURGERY HAD BEEN PERFORMED ON THE (B)(6) 2017, THE PATIENT UNDERWENT A SECOND REVISION ON THE (B)(6) 2022, IN WHICH THE GEN II 7.5MM RESUR PAT 35MM WAS REVISED DUE TO BEING LOOSE. THE PATIENT CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 13407420 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A REVISION SURGERY WAS PERFORMED DUE TO PAIN, SWELLING, AND INFECTION. GEN II 7.5MM RESUR PAT 35MMWAS EXPLANTED. HOWEVER, THE DOCTOR SAID THAT THE DEVICES WERE NOT DEFECTIVE. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. IT IS UNKNOWN IF THERE WAS A DELAY. NO COMPLICATIONS WERE REPORTED. NO PATIENT INFORMATION NEITHER MEDICAL REPORTS ARE AVAILABLE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 11236165 ↗
• MalfunctionOct 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD S+N SINCE 2019. THE PATIENT FELL AND RUPTURED HIS PATELLA TENDON. THE PATELLA IMPLANT WAS REMOVED AND THE PATELLA TENDON WITH ALLOGRAFT WAS PERFORMED. THE LINER WAS EXCHANGE TO A DISHED INSERT FOR ADDITIONAL STABILITY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Rupture

  MAUDE report 10744212 ↗
• InjuryOct 16, 2020Adverse 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, THE PATIENT EXPERIENCED PAIN AND INFECTION. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE IMPLANTS, ALTHOUGH THE SURGEON STATED THAT IMPLANTS WERE NOT DEFECTIVE. IT IS UNKNOWN IF EVENT WAS RESOLVED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 10689490 ↗
• InjuryOct 14, 2020Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WENT THROUGH A KNEE AND PATELLA REPLACEMENT. DURING SURGERY, WHILE CLEANING THE KNEE BEFORE CLOSING (ABOUT 12-15MIN AFTER CEMENTING), THE PATELLA POPPED OFF THE BONE AND CEMENT MANTLE. THE IMPLANT DETACHED FROM THE CEMENT AND BONE BEFORE THE SKIN INCISION WAS CLOSED. THE PATELLAR BONE WAS RE-PREPARED AND A NEW 7.5*35MM PATELLA (S+N BACKUP DEVICE) WAS IMPLANTED. THE CEMENT USED (SIMPLEX HV W/ GENTAMICIN REF #6195-1-001/LOT #937BA948HA & #939BB952KA) WAS A COMPETITOR'S PRODUCT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10681829 ↗
• InjuryAug 20, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO FAILURE OF GENESIS II 7.5MM RESURFACING PATELLA 35MM. THE PATELLA WAS DISASSOCIATED FROM BONE RESULTING IN NEED FOR REVISION SURGERY. NO ACUTE FALL, INJURY OR ADVERSE EVENT PRIOR TO REVISION SURGERY WAS REPORTED. STRYKER SIMPLEX HV WITH GENT WERE USED FOR PATELLA. THE SURGEON ALSO CONCERNED WITH THE AMOUNT OF "PITTING" ON THE POLY AFTER ONLY 4 YEARS OF PRIMARY IMPLANTATION.

  Patient problems: Failure of Implant; Injury

  MAUDE report 10433856 ↗
• InjuryApr 14, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AFTER PRIMARY SURGERY, USING JOURNEY II XR IMPLANTS PATIENT HAD KNEE STIFFNESS AND DECREASED RANGE OF MOTION. DESPITE PHYSICAL THERAPY; ADEQUATE PAIN MANAGEMENT, THE PATIENT WAS UNABLE TO MAINTAIN AN ACCEPTABLE POST OPERATIVE KNEE RANGE OF MOTION. A MANIPULATION UNDER ANESTHESIA WAS PERFORMED TO RESOLVE THE EVENT. PATIENT GAINED SIGNIFICANT RANGE OF MOTION AND WAS ABLE TO ACHIEVE MORE TERMINAL FLEXION.

  Patient problems: Loss of Range of Motion

  MAUDE report 9957558 ↗
• InjuryJan 13, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO THE DISLOCATION OF THE PATELLA INSERT. THE PATIENT HAD ACCOMPLISHED REHABILITATION.

  Patient problems: Joint Dislocation

  MAUDE report 9580753 ↗
• InjuryJan 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED REVISION SURGERY WAS PERFORMED DUE TO DISASSOCIATION OF THE PATELLA COMPONENT.

  Patient problems: Injury

  MAUDE report 9559444 ↗
• InjuryDec 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY TO EXPLANT A PATELLA DUE TO LOOSENING. INSERT WAS ALSO EXPLANTED.

  Patient problems: Injury

  MAUDE report 9413594 ↗
• InjuryMar 18, 2019Fracture; Fracture

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION, DAMAGED AND FRACTURE OF THE PATELLA COMPONENT.

  Patient problems: Joint Dislocation

  MAUDE report 8430547 ↗
• InjuryJul 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  LOOSE PATELLA WAS REASON FOR REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 7653962 ↗
• InjuryMar 19, 2018Mechanical Problem; Unintended Movement; Mechanical Problem; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO ASEPTIC LOOSENING AND MECHANICAL COMPLICATIONS OF THE DEVICE.

  Patient problems: Injury

  MAUDE report 7351133 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO PES TENDONITIS AND ITB SYNDROME ALSO TREATED WITH STEROID INJECTION.

  Patient problems: Injury; No Code Available

  MAUDE report 7110380 ↗
• InjuryDec 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISED WAS PERFORMED DUE TO STIFFNESS AFTER A RIGHT TKA.

  Patient problems: Injury

  MAUDE report 7075085 ↗
• InjuryNov 16, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON THE RIGHT KNEE FOR PATELLAR COMPONENT AND POLY EXCHANGE DUE TO KNEE PAIN, LEG PAIN, ASSOCIATED SWELLING AND LOOSENING OF INTERNAL PROSTHESIS RIGHT KNEE.

  Patient problems: Joint Swelling

  MAUDE report 7037117 ↗

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