NexGen® 5880-16-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024199170), received between May 13, 2021 and Aug 5, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Fracture” (5 reports).

4 other recalls cover devices cleared under the same FDA submission (K013385, K173057); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a right total knee arthroplasty and was subsequently revised approximately 1 year and 6 months post-implantation due to instability and mechanical loosening. Subsequently, 3 months after the revision, the patient began experiencing pain, swelling, stiffness, fever in the knee, and limitations in normal activities following the procedure. The devices remain implanted. Attempts have been made and no further information has been provided.

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema

  MAUDE report 50143821 ↗
• InjuryMar 5, 2026Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. APPROXIMATELY ONE (1) YEAR AND TEN (10) MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY DUE TO LOOSENING OF THE FEMORAL COMPONENT. DURING THE PROCEDURE, A FRACTURE WAS FOUND AT THE CONNECTION BETWEEN THE FEMORAL STEM EXTENSION AND THE FEMORAL COMPONENT. IT WAS REPORTED THAT THERE WAS NO PRIOR TRAUMA THAT CONTRIBUTED TO THE EVENT. DUE DILIGENCE IS IN PROGRESS FOR THIS EVENT; TO DATE NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Loss of Range of Motion; Pain

  MAUDE report 24519602 ↗
• InjuryDec 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, ABOUT A YEAR AND 4 MONTHS LATER, THE PATIENT HAD REVISION DUE TO LOOSENING. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Aseptic loosening; Radiolucent Lines

  MAUDE report 23693374 ↗
• InjuryOct 27, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NO ADDITIONAL INFORMATION TO REPORT.

  Patient problems: Aseptic loosening; Pain

  MAUDE report 23391392 ↗
• InjuryNov 13, 2024Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS FEMORAL HINGE FRACTURE APPROXIMATELY THREE (3) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 20678802 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL ROTATING HINGE KNEE ARTHROPLASTY PERFORMED AND SUBSEQUENTLY UNDERWENT TWO REVISION SURGERIES DUE TO DISASSOCIATION OF THE HINGE POST EXTENSION. APPROXIMATELY THREE (3) WEEKS FOLLOWING THE SECOND REVISION SURGERY, THE PATIENT PRESENTED WITH SIGNIFICANT PREPATELLAR SWELLING AND UNDERWENT ADDITIONAL SURGERY TO REPAIR THE QUADRICEPS TENDON. DURING THE PROCEDURE, PREPATELLAR BURSITIS WAS REMOVED, AND TWO AREAS OF PARTIAL RUPTURE OF THE VASTUS MEDIALIS OFF THE QUADRICEPS TENDON WERE NOTED. THERE WERE NO CONCERNS WITH THE IMPLANTS WHICH WERE ALL RETAINED. THE TENDON WAS REPAIRED WITHOUT COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Bursitis; Muscle/Tendon Damage; Swelling/ Edema

  MAUDE report 20523745 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A RIGHT TOTAL ROTATING HINGE KNEE ARTHROPLASTY PERFORMED AND SUBSEQUENTLY UNDERWENT TWO REVISION SURGERIES DUE TO DISASSOCIATION OF THE HINGE POST EXTENSION AS WELL AS A QUADRICEPS TENDON REPAIR PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS CONTINUED TO EXPERIENCE SIGNIFICANT PAIN WHICH INTERFERES WITH AMBULATION AND DAILY ACTIVITIES FOR TWO (2) YEARS FOLLOWING THE MOST RECENT PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION HAS BEEN REPORTED TO DATE TO ADDRESS THE CONTINUED PAIN. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 20523350 ↗
• InjuryOct 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION RIGHT TOTAL KNEE ARTHROPLASTY TO REPLACE THE HINGE POST. A POLYETHYLENE BEARING WAS IMPLANTED WITH A HINGE POST EXTENSION PACKAGED WITH ANOTHER DEVICE. APPROXIMATELY FOUR AND A HALF MONTHS POST IMPLANTATION, THE PATIENT PRESENTED WITH INSTABILITY AND IT WAS DETERMINED THAT THE HINGE POST EXTENSION OF THE ARTICULAR SURFACE DISASSOCIATED FOR A SECOND TIME. THE PATIENT AGAIN UNDERWENT REVISION SURGERY WHERE IT WAS NOTED THAT THE HINGE POST EXTENSION WAS ONLY PARTIALLY THREADED DESPITE THERE BEING NO OBVIOUS FAILURE OF THE COMPONENTS. WEAR OF THE POLYETHYLENE BEARING WAS ALSO NOTED. THE ENTIRE HINGE POST APPARATUS, HINGE POST EXTENSION, AND ARTICULAR SURFACE WERE REPLACED WITHOUT REPORTED COMPLICATION AND ALL OTHER COMPONENTS REMAINED WELL-FIXED AND INTACT. ALL AVAILABLE INFORMATION HAS BEEN REPORTED.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 20523291 ↗
• InjuryAug 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF ZB IMPLANTS APPROXIMATELY FOUR (4) YEARS POST-IMPLANTATION DUE TO INSTABILITY. DURING THE REVISION, IT WAS DISCOVERED THAT THE HINGE MECHANISM OF THE FEMORAL IMPLANT HAD BROKEN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Failure of Implant

  MAUDE report 20049868 ↗
• InjuryJun 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE REVISION APPROXIMATELY FIVE (5) YEARS POST-IMPLANTATION DUE TO PAIN AND LAXITY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19475258 ↗
• InjuryOct 4, 2023Material Erosion; Fracture; Noise, Audible; Material Erosion; Fracture; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL KNEE SURGERY. SUBSEQUENTLY, THE PATIENT WAS REVISED APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO PAIN, SWELLING, HYPER-EXTENSION, AND CLICKING NOISE. DURING THE REVISION, FRACTURE OF THE HINGE MECHANISM, WEAR OF THE FEMORAL COMPONENT AND METALLOSIS WERE NOTED. THE PATIENT UNDERWENT EXCHANGE OF THE FEMORAL COMPONENT AND LINER WITHOUT COMPLICATION. THE INITIAL TIBIAL COMPONENT AND PATELLA REMAINED IMPLANTED. IT WAS REPORTED NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant; Hyperextension; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 17867688 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT NO IMPLANTS DISLOCATED, HOWEVER, THE LCL AND MCL HAD FAILED CAUSING A LACK OF STABILITY IN THE JOINT. THE SURGEON IMPLANTED A ROTATING HINGE KNEE SYSTEM TO PROVIDE ROTATIONAL STABILITY. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 17698915 ↗
• InjuryAug 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL RIGHT TOTAL KNEE ARTHROPLASTY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO CHRONIC INFECTION. ALL COMPONENTS WERE REVISED WITHOUT COMPLICATIONS.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 17614962 ↗
• InjuryJun 29, 2023Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Bacterial Infection; Erosion; Failure of Implant; Inflammation; Necrosis; Scar Tissue

  MAUDE report 17228786 ↗
• InjuryJun 15, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED, THAT: TODAY WE REVISED AN RHK FEMUR AS IT WAS EXPLAINED BY THE OPERATING SURGEON THAT THE PATIENT'S RIGHT KNEE JOINT LINE WAS OUT OF ALIGNMENT. IT WAS THEREFORE DECIDED TO REVISE THE FEMUR AND IMPLANT THE SAME SIZE FEMUR (SIZE F) WITH A LONGER STEM (200MM OFFSET STEM) AND DISTAL AUGMENTS TO DISTALISE THE FEMUR ARE CORRECT THE JOINT LINE. NO DELAY. PATIENT OUTCOME: REVISION.

  Patient problems: Failure of Implant

  MAUDE report 14704763 ↗
• InjuryMay 13, 2021Fracture; Naturally Worn; Noise, Audible; Fracture; Naturally Worn; Noise, Audible

  IT WAS FURTHER REPORTED THROUGH PATIENT¿S MEDICAL RECORDS THAT THE PATIENT WAS REVISED DUE TO PAIN, FRACTURE OF THE ROTATING HINGE POST, AND METALLOSIS. DURING THE REVISION, THE SURGEON NOTED THE FRACTURED HINGE POST WAS LOCATED ANTERIORLY IN THE KNEE, AND A SMALLER FRAGMENT WAS DEPRESSED INTO THE POLYETHYLENE. SUPERFICIAL WEAR WAS NOTED ON THE FEMORAL COMPONENT AND ALSO METALLOSIS WAS NOTED UNDER THE FEMORAL COMPONENT. THE FEMORAL COMPONENTS AND ARTICULAR SURFACE WERE REVISED WITHOUT COMPLICATION. THE SURGEON NOTED THAT THE EXTENSOR MECHANISM WILL LIKELY NEED ADDITIONAL SURGICAL INTERVENTION ON A LATER DATE. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Damage to Ligament(s); Failure of Implant; Joint Laxity; Local Reaction; Metal Related Pathology; Pain

  MAUDE report 11820767 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013385, K173057. One submission often covers many models, so check the product and lot details in each record.

• Z-2092-2023 · May 19, 2023 · Terminated
  NexGen Precoat Stemmed Tibial Plate Size 5
• Z-0321-2020 · Oct 10, 2019 · Terminated
  Various Knee Systems for knee joint arthroplasty, knee prosthesis, Item Nos. 00522000100 00522000200 00522000300 00522000400 00522006304 00522006504 00522006600 00522006800
• Z-1448-04 · Aug 3, 2004 · Terminated
  Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 3, sterile, for cemented use only; Cat. No. 5880-03-02.
• Z-1447-04 · Aug 3, 2004 · Terminated
  Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2, sterile, for cemented use only; Cat. No. 5880-02-02.