NEXGEN TRABECULAR METALRecalls & reported problems across all models
Zimmer Trabecular Metal Technology Inc. · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 57
- Deaths reported
- 0
- Injuries reported
- 56
- Recalls
- 2
We found 10 models of NEXGEN TRABECULAR METAL by Zimmer Trabecular Metal Technology Inc. in the FDA's device registry (GUDID). Together they are named in 57 adverse event reports in the FDA's MAUDE database, received between May 20, 2019 and Apr 30, 2026 — classified as 56 injuries, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (18 reports).
2 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
NEXGEN TRABECULAR METAL recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 1, 2019Class IITerminated
Potentially comingled, resulting in the product in the box potentially not matching the product on the label
Z-1006-2019 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
- Feb 1, 2019Class IITerminated
Potentially comingled, resulting in the product in the box potentially not matching the product on the label
Z-1005-2019 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗
Most reported NEXGEN TRABECULAR METAL problems
Device problems
- Adverse Event Without Identified Device or Use Problem24
- Fracture18
- Loosening of Implant Not Related to Bone-Ingrowth7
- Noise, Audible4
- Unstable4
- Appropriate Device Problem Term/Code Not Available3
- Insufficient Device Problem Information3
- Biocompatibility2
Patient problems
- Pain25
- Failure of Implant14
- Loss of Range of Motion8
- Insufficient Information6
- Swelling6
- Swelling/ Edema6
- Ambulation or Postural Difficulties4
- No Clinical Signs, Symptoms or Conditions4
NEXGEN TRABECULAR METAL models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NEXGEN® TRABECULAR METAL® 00-5448-004-26PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall0 reports
- NEXGEN® TRABECULAR METAL® 00-5448-004-36PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- NEXGEN® TRABECULAR METAL® 00-5878-065-32PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER24 reports
- NEXGEN® TRABECULAR METAL® 00-5878-065-35PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- NEXGEN® TRABECULAR METAL™ 00-5878-065-38PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER6 reports
- NEXGEN® TRABECULAR METAL® 00-5878-065-41PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- NEXGEN® TRABECULAR METAL® 00-5878-065-29PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- NEXGEN® TRABECULAR METAL™ 00-5490-034-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- NEXGEN® TRABECULAR METAL® 00-5448-006-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- NEXGEN® TRABECULAR METAL™ 00-5490-036-20PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
Recent NEXGEN TRABECULAR METAL adverse event reports
The 15 most recent reports across all models, 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 ↗InjuryMar 20, 2026Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A KNEE REVISION APPROXIMATELY TWO (2) YEARS POST-IMPLANTATION AFTER EXPERIENCING A FALL THAT RESULTED IN THE POST OF THE NEXGEN PATELLA FRACTURING. DURING THE REVISION, THE PATELLA WAS EXPLANTED; HOWEVER, THE FRACTURED PEG PORTION WAS UNABLE TO BE REMOVED AND REMAINS IN THE PATIENT. NO OTHER PATIENT CONSEQUENCES WERE REPORTED AS A RESULT OF THE EVENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 24650116 ↗InjuryMar 13, 2026Fracture
IT WAS REPORTED THAT A PATIENT WAS REVISED DUE TO THE PATELLA FRACTURING AFTER THE PATIENT WAS WEIGHT BEARING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 24597835 ↗InjuryDec 22, 2025Fracture; Fracture
UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS ITEM WAS REPORTED UNDER THE WRONG MFR. THE REPORT WILL BE SUBMITTED UNDER MFR 3005751028.
Patient problems: Insufficient Information
MAUDE report 23863436 ↗InjuryOct 15, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION DUE TO PATELLA IMPLANT FRACTURE APPROXIMATELY TWO (2) YEARS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23303703 ↗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 ↗InjuryFeb 20, 2025Adverse 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: Bone Fracture(s)
MAUDE report 21420466 ↗InjuryJan 8, 2025Fracture; Fracture
IT WAS REPORTED THE PATELLA WAS FOUND FRACTURED AT A POST SURGERY OFFICE VISIT. THERE IS A PLAN TO REVISE THE PATELLA BUT A DATE HAS NOT BEEN CONFIRMED.
Patient problems: Failure of Implant
MAUDE report 21102356 ↗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 ↗InjurySep 26, 2024Fracture; Fracture
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Failure of Implant; Foreign Body In Patient
MAUDE report 20310322 ↗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 ↗
Other Zimmer Trabecular Metal Technology Inc. products
All Zimmer Trabecular Metal Technology Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page