Persona The Personalized Knee OsseoTiRecalls & reported problems across all models
Zimmer, Inc. · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls
- 0
We found 14 models of Persona The Personalized Knee OsseoTi by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between May 3, 2023 and Sep 30, 2026 — classified as 28 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (7 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. 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
Most reported Persona The Personalized Knee OsseoTi problems
Device problems
- Adverse Event Without Identified Device or Use Problem18
- Packaging Problem7
- Loosening of Implant Not Related to Bone-Ingrowth6
- Implant subsidence3
- Positioning Failure3
- Device Contaminated During Manufacture or Shipping2
- Device Damaged Prior to Receipt by User2
- Failure to Osseointegrate2
Patient problems
- No Clinical Signs, Symptoms or Conditions16
- Pain13
- Ambulation or Postural Difficulties5
- Aseptic loosening4
- Joint Laxity4
- Loss of Range of Motion4
- Radiolucent Lines3
- Swelling/ Edema3
Persona The Personalized Knee OsseoTi models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Persona® The Personalized Knee® OsseoTi® 42-5350-075-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- Persona® The Personalized Knee® OsseoTi® 42-5350-067-02PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER7 reports
- Persona® The Personalized Knee® OsseoTi® 42-5350-079-01Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive6 reports
- Persona® The Personalized Knee® OsseoTi® 42-5350-079-02PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER5 reports
- Persona® The Personalized Knee® OsseoTi® 42-5350-071-01PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- Persona® The Personalized Knee® OsseoTi® 42-5350-071-02PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- Persona® The Personalized Knee® OsseoTi® 42-5405-000-35PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Persona® The Personalized Knee® OsseoTi® 42-5350-064-02PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- Persona® The Personalized Knee® OsseoTi® 42-5350-075-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Persona® The Personalized Knee® OsseoTi® 42-5350-083-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Persona® The Personalized Knee® OsseoTi® 42-5350-083-02PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- Persona® The Personalized Knee® OsseoTi® 42-5350-064-01Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive1 report
- Persona® The Personalized Knee® OsseoTi® 42-5350-067-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Persona® The Personalized Knee® OsseoTi® 42-5405-000-38PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent Persona The Personalized Knee OsseoTi adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947925 ↗MalfunctionSep 29, 2026Melted; Device Damaged Prior to Receipt by User
It was reported that when the outer box of a tibial implant was opened, the inner portion appeared deformed, as if melted. There was no surgical delay. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931478 ↗MalfunctionSep 23, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869966 ↗MalfunctionSep 23, 2026Packaging Problem
It was reported that upon opening the outer package of the implant box, the plastic packaging around the implant was observed to be deformed. The surgery was completed with a second device. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867758 ↗MalfunctionSep 22, 2026Packaging Problem
It was reported that prior to an initial total knee arthroplasty, the implant packaging was found to be warped. The product was not used. No patient impact or adverse events have been reported as a result of the malfunction. All available information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858856 ↗InjuryAug 10, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported that the patient underwent a right knee arthroplasty revision to address tibial fibrous ingrowth approximately two (2) years post-operatively.Attempts have been made and no further information has been provided.
Patient problems: Arthrofibrosis; Aseptic loosening
MAUDE report 50192481 ↗MalfunctionAug 6, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50161449 ↗InjuryAug 3, 2026Loosening of Implant Not Related to Bone-Ingrowth
It was reported the patient underwent an initial knee arthroplasty on an unknown date. Subsequently, the patient was revised due to tibial loosening. It was noted it appears clinically as fibrous in growth.
Patient problems: Aseptic loosening
MAUDE report 50116477 ↗MalfunctionJul 30, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50082349 ↗MalfunctionJul 17, 2026Positioning Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25857582 ↗MalfunctionJun 15, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THERE WAS A HAIR FOUND IN THE STERILE PACKAGING. THE SURGERY WAS COMPLETED WITH A SECOND DEVICE. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25504227 ↗InjuryMar 23, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS FURTHER REPORTED THAT THE PATIENT WAS REVISED APPROXIMATELY 6 MONTHS POST-OP. THE TIBIAL TRAY WAS REVISED. THE SURGEON NOTED THAT THE PATIENT'S BONE WAS NOTED TO BE OSTEOPOROTIC UPON REMOVING THE IMPLANTS. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Osteopenia/ Osteoporosis; Pain
MAUDE report 24668159 ↗InjuryFeb 19, 2026Failure to Osseointegrate
IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION TO ADDRESS INADEQUATE OSSEOINTEGRATION. DURING THE PROCEDURE, THE TIBIAL AND FEMORAL COMPONENTS WERE NOTED TO NOT HAVE ANY BONY INGROWTH. THE FEMORAL COMPONENT WAS ALSO NOTED TO BE DELAMINATED. ATTEMPTS HAVE BEEN MADE; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Patient problems: Inadequate Osseointegration
MAUDE report 24387405 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Joint Laxity; Loss of Range of Motion; Pain
MAUDE report 24382524 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED CONTINUED PAIN, SWELLING, LAXITY AND STIFFNESS SINCE UNDERGOING A KNEE ARTHROPLASTY TEN (10) MONTHS PRIOR. INITIAL OPERATIVE NOTES NOTE NO INTRAOPERATIVE COMPLICATIONS. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Joint Laxity; Loss of Range of Motion; Pain
MAUDE report 24382496 ↗
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
- PERSONA Natural Tibia25 models · 417 reports · 2 recalls
- NexGen Legacy119 models · 319 reports · 3 recalls
- Alliance32 models · 275 reports · 2 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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