NEXGEN® TRABECULAR METAL® 00-5878-065-32Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00889024309807), received between May 20, 2019 and Apr 30, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Fracture” (9 reports).

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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT RIGHT KNEE A TWO-STAGE REVISION FOR INFECTION. APPROXIMATELY SEVEN MONTHS LATER THE PATIENT BEGAN TO HAVE INTERMITTENT PAIN AND SWELLING. TWO YEARS AND FIVE MONTHS LATER THE PATIENT REPORTED AN INCREASE IN PAIN AND WAS PRESCRIBED PHYSICAL THERAPY. ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 25045506 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PATELLAR PAIN APPROXIMATELY FOURTEEN (14) MONTHS POST-OPERATIVELY. DURING THE REVISION, THE SURGEON ALSO EXCHANGED THE ARTICULAR SURFACE FOR A LARGER SIZE TO ACHIEVE BETTER STABILITY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 25016087 ↗
• InjuryApr 16, 2026Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS POST-OPERATIVE PEG FRACTURE OF THE PATELLAR IMPLANT APPROXIMATELY SEVENTEEN (17) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 24899225 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY SEVEN (7) MONTHS POST-IMPLANTATION DUE TO A BONE FRACTURE OF THE PATIENT'S PATELLA. THE TM PATELLA WAS REMOVED AND OSTEOSYNTHESIS WAS PERFORMED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 24757709 ↗
• InjuryAug 21, 2025Fracture; Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

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

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Pain

  MAUDE report 22861495 ↗
• InjuryDec 2, 2024Fracture; Fracture

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

  Patient problems: Failure of Implant

  MAUDE report 20819016 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY SEVEN (7) MONTHS POST-IMPLANTATION DUE TO A BONE FRACTURE OF THE PATIENT'S PATELLA. THE TM PATELLA WAS REMOVED AND OSTEOSYNTHESIS WAS PERFORMED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Bone Fracture(s)

  MAUDE report 20520958 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD NERVE ABLATIONS PERFORMED DUE TO CHRONIC PROBLEMS POST IMPLANTATION. THE PATIENT IS PLANNING A LEFT KNEE REVISION SURGERY, NO REVISION PROCEDURE HAS BEEN REPORTED TO DATE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 19369962 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT UNDERWENT RIGHT KNEE A TWO STAGE REVISION FOR INFECTION. SUBSEQUENTLY, APPROXIMATELY 7 MONTHS LATER THE PATIENT BEGAN TO HAVE INTERMITTENT PAIN AND SWELLING AND 2 YEARS FIVE MONTHS REPORTED AN INCREASE IN PAIN AND WAS PRESCRIBED PHYSICAL THERAPY. ALL IMPLANTS REMAIN IN PLACE.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 19139750 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Ambulation or Postural Difficulties; Loss of Range of Motion; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19133109 ↗
• InjuryMar 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PATELLA PAIN APPROXIMATELY FOURTEEN (14) MONTHS POST-OPERATIVELY. DURING THE REVISION, THE SURGEON ALSO EXCHANGED THE ARTICULAR SURFACE FOR A LARGER SIZE TO ACHIEVE BETTER STABILITY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 18952101 ↗
• InjuryFeb 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY SIX YEARS POST-IMPLANTATION DUE TO PATELLA FRACTURE FOLLOWING SOME FALLS.

  Patient problems: Failure of Implant; Fall

  MAUDE report 18629322 ↗
• InjuryJan 8, 2024Fracture; Fracture

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

  Patient problems: Pain

  MAUDE report 18468827 ↗
• InjuryJan 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION OF THE TIBIAL TRAY TO ADDRESS PAIN APPROXIMATELY SIXTEEN (16) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Pain

  MAUDE report 18425701 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY FOUR YEARS POST-IMPLANTATION DUE TO PAIN. THE TIBIAL INSERT AND TRAY WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Pain

  MAUDE report 18306573 ↗
• InjuryApr 4, 2023Fracture; Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Unstable; Noise, Audible; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION DUE TO THE POST SHEARING OFF THE PATELLAR COMPONENT APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Ambulation or Postural Difficulties; Aseptic loosening; Failure of Implant; Pain

  MAUDE report 16674520 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT INITIAL RIGHT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY HAD A MANIPULATION UNDER ANESTHESIA TWO MONTHS POST PROCEDURE DUE TO STIFFNESS. COMPONENTS REMAIN IMPLANTED. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Loss of Range of Motion

  MAUDE report 14073720 ↗
• InjuryOct 4, 2021Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Migration; Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Migration

  IT WAS REPORTED THAT APPROXIMATELY 5 YEARS POST IMPLANTATION, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO THE PATELLA BECOMING LOOSE AND SHEARED OFF. A NEW ZIMMER CEMENTED PATELLA WAS IMPLANTED. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: Failure of Implant

  MAUDE report 12569717 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A PRIMARY KNEE PROCEDURE. SUBSEQUENTLY, THE PATIENT HAS COMPLAINED OF FEMORAL & TIBIAL PAIN. PAIN MORE CONCENTRATED ON MEDIAL PROXIMAL TIBIAL, SINCE SURGERY. IT WAS REPORTED THE PATIENT'S KNEE HAS BEEN SWOLLEN SINCE SURGERY. THE PATIENT HAS A NEXGEN IN OPPOSITE SIDE WITH NO PAIN OR POST OP ISSUES. THE DOCTOR IS CONCERNED ABOUT HIS PATIENT OUTCOMES WITH PERSONA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 12561351 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Burning Sensation; Pain; Swelling/ Edema

  MAUDE report 11313742 ↗
• InjuryDec 16, 2019Fracture; Fracture

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

  Patient problems: No Information

  MAUDE report 9475149 ↗
• InjurySep 17, 2019Noise, Audible

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

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling

  MAUDE report 9079313 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS POST IMPLANTATION, THE PATIENT WAS NOTED TO HAVE STIFFNESS AND DECREASED RANGE OF MOTION. SUBSEQUENTLY, THE PATIENT UNDERWENT A MANIPULATION UNDER ANESTHESIA. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9072781 ↗
• InjuryMay 20, 2019Fracture; Insufficient Device Problem Information; Noise, Audible; Fracture; Insufficient Device Problem Information; Noise, Audible

  IT WAS REPORTED THAT THE PATIENT UNDERWENT INITIAL KNEE ARTHROPLASTY ON (B)(6) 2015. SUBSEQUENTLY, THE KNEE STARTED SWELLING AND CAUSED PAIN. SWELLING CONTINUED. KNEE WAS WEAK AND PATIENT COULDN'T EXTEND THE LEG. KNEE OCCASIONALLY CLICKED. PATIENT WAS ABLE TO PUSH ON A SPECIFIC SPOT TO CAUSE PAIN. PATIENT IS SCHEDULED FOR REVISION (B)(6) 2019. NEW INFORMATION ( MAY 16, 2019). PATIENT REVISED ON (B)(6) 2019 AND THE TM PATELLA WAS REVISED. PATIENT CALLED AND TOLD ZIMMER BIOMET MEMBER THAT THE PATELLA WAS FOUND TO BE FRACTURED UPON SURGERY AND WAS CERTAIN THAT PATELLA IS THE ONLY PART THAT WAS REVISED. TM PATELLA AND TM POSTERIOR STABILIZED MONOBLOCK TIBIAL COMPONENT ARE ONLY THE TMT DESIGN CONTROL PARTS .

  Patient problems: Failure of Implant; Pain; Swelling

  MAUDE report 8624031 ↗