PERSONA Natural TibiaRecalls & reported problems across all models
Zimmer, Inc. · 25 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 417
- Deaths reported
- 0
- Injuries reported
- 381
- Recalls
- 2
We found 25 models of PERSONA Natural Tibia by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 417 adverse event reports in the FDA's MAUDE database, received between Oct 8, 2019 and Sep 28, 2026 — classified as 381 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (120 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
PERSONA Natural Tibia 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.
- Aug 7, 2017Terminated
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Z-1806-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 7, 2017Terminated
There is a potential for intermittent cracks in the raw material batch used to produce the affected products. The cleanliness of the affected products could be compromised if cracks penetrate the surface of the instrument as a result of the raw material issue.
Z-1805-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported PERSONA Natural Tibia problems
Device problems
- Adverse Event Without Identified Device or Use Problem205
- Loosening of Implant Not Related to Bone-Ingrowth120
- Loss of or Failure to Bond26
- Migration18
- Unstable11
- Fracture9
- Insufficient Device Problem Information9
- Malposition of Device8
Patient problems
- Pain202
- Failure of Implant101
- Swelling/ Edema74
- Loss of Range of Motion56
- Ambulation or Postural Difficulties35
- No Clinical Signs, Symptoms or Conditions35
- Scar Tissue32
- Joint Laxity27
PERSONA Natural Tibia models
25 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PERSONA® Natural Tibia® 42-5320-071-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER64 reports
- PERSONA™ Natural Tibia™ 42-5321-083-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- PERSONA™ Natural Tibia™ 42-5321-083-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- PERSONA® Natural Tibia® 42-5320-067-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER47 reports
- PERSONA® Natural Tibia® 42-5320-071-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER43 reports
- PERSONA® Natural Tibia® 42-5320-075-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER40 reports
- PERSONA® Natural Tibia® 42-5320-067-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER39 reports
- PERSONA® Natural Tibia® 42-5320-075-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER34 reports
- PERSONA® Natural Tibia® 42-5320-064-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER28 reports
- PERSONA® Natural Tibia® 42-5320-079-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER28 reports
- PERSONA® Natural Tibia® 42-5320-079-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER27 reports
- PERSONA® Natural Tibia® 42-5320-064-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER25 reports
- PERSONA™ Natural Tibia™ 42-5320-067-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- PERSONA® Natural Tibia® 42-5320-083-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- PERSONA™ Natural Tibia™ 42-5320-071-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- PERSONA® Natural Tibia® 42-5320-061-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Natural Tibia® 42-5320-061-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Natural Tibia® 42-5320-083-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- PERSONA™ Natural Tibia™ 42-5320-064-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- PERSONA™ Natural Tibia™ 42-5320-067-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- PERSONA™ Natural Tibia™ 42-5320-075-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- PERSONA™ Natural Tibia™ 42-5320-064-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- PERSONA™ Natural Tibia™ 42-5320-071-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- PERSONA™ Natural Tibia™ 42-5320-075-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- PERSONA™ Natural Tibia™ 42-5320-079-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent PERSONA Natural Tibia adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent an initial left knee surgery. Subsequently, the patient fell, fractured their fibula, and blew out their MCL and was revised approximately 4 years post-op. Attempts have been made and all available information has been provided.
Patient problems: Bone Fracture(s); Damage to Ligament(s)
MAUDE report 50919292 ↗InjurySep 23, 2026Improper or Incorrect Procedure or Method
It was reported that wrong-side implants were implanted. It was noticed after the case, and the patient had to be revised. There was a 1-2 hour delay.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867505 ↗InjurySep 22, 2026Implant subsidence
Patient problems: Joint Laxity
MAUDE report 50859875 ↗InjurySep 22, 2026Loosening of Implant Not Related to Bone-Ingrowth
Patient problems: Aseptic loosening
MAUDE report 50857621 ↗InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent an initial left total knee arthroplasty. Subsequently, the patient reported lateral knee pain with occasional swelling approximately 2 years post-op. Lucency was noted on CT scan. Physical therapy was prescribed. Attempts have been made and all available information has been provided.
Patient problems: Pain; Swelling/ Edema
MAUDE report 50495783 ↗InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that during a total knee arthroplasty, vascular bleeding occurred immediately after implantation upon tourniquet release due to injury to the popliteal artery. The bleeding was identified intra-operatively after tourniquet deflation, haemostasis was performed, and the components that had been placed were removed during the same procedure, adding an additional two hours to the procedure. The patient was revised seven days later. Attempts have been made and no further information has been provided.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels
MAUDE report 50411510 ↗InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent an initial right total knee arthroplasty. Two weeks following the initial physical therapy treatment, the patient began to experience a sudden onset of intense pain after waking up. Subsequently, the patient underwent two (2) additional rounds of physical therapy. Four (4) months post-implantation, the patient continues to have pain and decreased range of motion. Due diligence is in progress for this event; to date all available information has been provided.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 50333306 ↗InjuryAug 10, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that the patient underwent an initial left knee surgery. Subsequently, the patient was revised due to femoral and tibial loosening approximately 4 years post-op. All available information has been provided.
Patient problems: Aseptic loosening
MAUDE report 50191690 ↗InjuryAug 6, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that a patient was revised approximately five years eleven and half months post implantation due to pain and tibial loosening. There is no additional information available.
Patient problems: Aseptic loosening; Pain
MAUDE report 50157880 ↗InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient underwent a revision approximately 2 years and 8 months post-implantation due to flexion instability. It was reported that no further information is available.
Patient problems: Joint Laxity
MAUDE report 50133120 ↗InjuryAug 3, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that the patient underwent an initial knee surgery. Subsequently, the patient was revised due to both femoral and tibial loosening approximately 2 years post-op. The bone-cement interface was intact on both the tibia and femur, however, the implant-cement interface was where the loosening occurred. All available information has been provided.
Patient problems: Aseptic loosening
MAUDE report 50114051 ↗InjuryJul 31, 2026Migration
It was reported that the patient underwent a knee arthroplasty revision to address tibial tray migration resulting in instability. Upon removal of the components, femoral osteolysis around the metaphyseal region of the femur was identified that extended to the posterior condyles both medially and laterally. All components were revised and replaced. Attempts have been made, however, no additional information is available.
Patient problems: Joint Laxity; Osteolysis
MAUDE report 50100361 ↗InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported the patient underwent an initial right total knee arthroplasty. Subsequently, approximately five months post-implantation, the patient received a bupivacaine injection for pes anserinus bursitis and iliotibial band tendonitis. The patient experienced resolution of symptoms and reported being satisfied with the outcome. Attempts have been made and no further information has been provided.
Patient problems: Bursitis; Tendinopathy
MAUDE report 50017532 ↗MalfunctionJun 25, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED DURING KNEE ARTHROPLASTY THAT WHEN THE TIBIAL TRAY WAS OPENED, AN UNKNOWN RESIDUE WAS IDENTIFIED ON THE SURFACE OF THE IMPLANT. NO ABNORMALITIES WERE IDENTIFIED WITH THE IMPLANT PACKAGING. ANOTHER IMPLANT WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25627979 ↗InjuryJun 5, 2026Positioning Failure; Fracture
IT WAS REPORTED THAT DURING A KNEE ARTHROPLASTY, THE SURGEON DESCRIBED DIFFICULTY INSERTING THE BEARING ONTO THE TIBIAL TRAY. HE SUGGESTED THAT WHEN USING THE INSERTER, IT APPEARED THAT A PIECE OF METAL SHEARED OFF AND WAS CAUSING THE POLY TO NOT SIT INTO THE TIBIA CORRECTLY. AS THE TIBIA WAS ALREADY CEMENTED IN SITU, THE PIECE WAS UNABLE TO BE RETRIEVED. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Foreign Body In Patient
MAUDE report 25408051 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 reports
- PERSONA Vivacit-E285 models · 1,152 reports
- NexGen198 models · 842 reports · 4 recalls
- Affixus18 models · 1 reports · 17 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 recalls
- Comprehensive18 models · 103 reports · 3 recalls
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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