Persona Partial Knee SystemRecalls & reported problems across all models
Biomet Orthopedics, LLC · 60 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 201
- Deaths reported
- 0
- Injuries reported
- 179
- Recalls
- 0
We found 60 models of Persona Partial Knee System by Biomet Orthopedics, LLC in the FDA's device registry (GUDID). Together they are named in 201 adverse event reports in the FDA's MAUDE database, received between Oct 15, 2019 and Sep 30, 2026 — classified as 179 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (25 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 Partial Knee System problems
Device problems
- Adverse Event Without Identified Device or Use Problem129
- Loosening of Implant Not Related to Bone-Ingrowth25
- Difficult to Insert15
- Unstable10
- Migration7
- Noise, Audible6
- Naturally Worn4
- Patient Device Interaction Problem4
Patient problems
- Pain147
- Failure of Implant24
- Swelling/ Edema20
- No Clinical Signs, Symptoms or Conditions18
- Bone Fracture(s)16
- Swelling13
- Fall12
- Joint Laxity9
Persona Partial Knee System models
60 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Persona® Partial Knee System 42-5580-004-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER12 reports
- Persona® Partial Knee System 42-5580-003-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- Persona® Partial Knee System 42-5380-005-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- Persona® Partial Knee System 42-5282-005-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- Persona® Partial Knee System 42-5380-004-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- Persona® Partial Knee System 42-5380-006-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER9 reports
- Persona® Partial Knee System 42-5380-007-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- Persona® Partial Knee System 42-5580-005-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- Persona® Partial Knee System 42-5380-005-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- Persona® Partial Knee System 42-5380-007-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER7 reports
- Persona® Partial Knee System 42-5580-004-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- Persona® Partial Knee System 42-5580-006-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- Persona® Partial Knee System 42-5580-006-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- Persona® Partial Knee System 42-5380-004-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- Persona® Partial Knee System 42-5182-005-09PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- Persona® Partial Knee System 42-5580-007-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- Persona® Partial Knee System 42-5580-003-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- Persona® Partial Knee System 42-5580-005-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- Persona® Partial Knee System 42-5380-006-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- Persona® Partial Knee System 42-5182-004-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER4 reports
- Persona® Partial Knee System 42-5380-003-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Persona® Partial Knee System 42-5182-006-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Persona® Partial Knee System 42-5282-006-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Persona® Partial Knee System 42-5182-007-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Persona® Partial Knee System 42-5282-007-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Persona® Partial Knee System 42-5282-007-09PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER3 reports
- Persona® Partial Knee System 42-5580-001-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5580-002-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5580-007-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5380-008-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5380-008-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5282-004-09PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5182-005-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5182-005-10PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5282-005-09PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5182-006-09PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5182-006-11PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5282-006-10PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5182-008-09PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 reports
- Persona® Partial Knee System 42-5580-002-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5380-003-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5380-009-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5380-009-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-003-09PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-003-10PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-003-12PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5282-003-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-004-09PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-004-10PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-004-11PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5282-004-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5282-004-10PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-005-11PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-006-10PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-006-12PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-007-09PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-007-10PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5182-008-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5282-008-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
- Persona® Partial Knee System 42-5282-008-10PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 report
Recent Persona Partial Knee System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Laxity; Periprosthetic fracture
MAUDE report 50946495 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient had an initial left partial knee arthroplasty performed. Approximately 6-8 weeks postop, the patient underwent an open reduction internal fixation. The initial partial knee implants remained intact. About 2 years later, the patient swung his club while golfing and felt a pop in his knee which gave out. The surgeon told the patient at follow-up that he will need to be converted to a total knee. Further follow up with the patient indicates that a revision to a total knee arthroplasty was performed approximately a month after that. During the revision, bone filler was applied to a periprosthetic fracture. No intraop or further complications have been reported. The patient currently has no complaints with the new knee. No further information has been provided.
Patient problems: Joint Laxity; Periprosthetic fracture
MAUDE report 50946491 ↗InjurySep 30, 2026Implant subsidence
It was reported that a patient had an initial left partial knee arthroplasty performed. Approximately 6-8 weeks postop, the patient was participating in physical therapy and felt a sudden pain with inability to walk. X-rays revealed a periprosthetic tibial fracture with implant subsidence. As a result, the patient underwent an open reduction internal fixation. The initial partial knee implants remained intact. No further details regarding the event are known at this time.
Patient problems: Ambulation or Postural Difficulties; Pain; Periprosthetic fracture
MAUDE report 50946339 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient had an initial left partial knee arthroplasty performed. Approximately 6-8 weeks postop, the patient underwent an open reduction internal fixation. The initial partial knee implants remained intact. About 2 years later, the patient swung his club while golfing and felt a pop in his knee which gave out. The surgeon told the patient at follow-up that he will need to be converted to a total knee. Further follow up with the patient indicates that a revision to a total knee arthroplasty was performed approximately a month after that. During the revision, bone filler was applied to a periprosthetic fracture. No intraop or further complications have been reported. The patient currently has no complaints with the new knee. No further information has been provided.
Patient problems: Joint Laxity; Periprosthetic fracture
MAUDE report 50946334 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information
MAUDE report 50935696 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information
MAUDE report 50935675 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Insufficient Information
MAUDE report 50935673 ↗InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
It was reported from a clinical study that the patient experienced moderate to severe knee pain and stiffness following an initial left partial knee arthroplasty. This was mentioned at follow-up visits through approximately five years post-implantation, symptoms were managed with acetaminophen and nonsteroidal anti-inflammatory drugs. The implants remained in place without further intervention. Attempts have been made and no further information has been provided.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 50332428 ↗InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem
It was reported from a clinical study that the patient experienced moderate to severe knee pain and stiffness following an initial left partial knee arthroplasty. This was mentioned at follow-up visits through approximately five years post-implantation, symptoms were managed with acetaminophen and nonsteroidal anti-inflammatory drugs. The implants remained in place without further intervention. Attempts have been made and no further information has been provided.
Patient problems: Loss of Range of Motion; Pain
MAUDE report 50332421 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
No further event information available at the time of this report.
Patient problems: Pain
MAUDE report 50174778 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
It was reported in a clinical study that at the two-year follow-up visit a patient reported experiencing increased pain and dissatisfaction. Home strengthening exercises were recommended as well as over the counter medication for pain. All implants remain intact, and no further information has been provided at this time. Attempts to obtain additional information have been made; however, no more information is available at this time.
Patient problems: Pain
MAUDE report 50174757 ↗InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem
No further event information available at the time of this report.
Patient problems: Pain
MAUDE report 50174747 ↗InjuryMar 19, 2026Loosening of Implant Not Related to Bone-Ingrowth
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL BILATERAL PPK SURGERY. SUBSEQUENTLY, THE PATIENT COMPLAINED OF PROXIMAL TIBIAL PAIN ON THE LEFT AND WAS REVISED DUE TO PAIN AND TIBIAL LOOSENING APPROXIMATELY 1 YEAR POST-OP. THE SURGEON NOTED THERE WAS SLIGHT TIBIAL MICROMOTION. ALL COMPONENTS WERE REVISED. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Aseptic loosening; Pain
MAUDE report 24639620 ↗InjuryFeb 17, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT PARTIAL KNEE ARTHROPLASTY. APPROXIMATELY 13 MONTHS POST-OP, THE PATIENT EXPERIENCED INSTABILITY. SUBSEQUENTLY, THE PATIENT WAS REVISED. THE IMPLANT WAS REMOVED. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.
Patient problems: Joint Laxity
MAUDE report 24369857 ↗MalfunctionDec 17, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT DURING AN INITIAL PARTIAL KNEE ARTHROPLASTY, FOREIGN MATERIAL RESEMBLING A HUMAN HAIR WAS OBSERVED UPON OPENING OF THE DEVICE PACKAGING. THE DEVICE WAS IMPLANTED HOWEVER THERE WAS NO PATIENT IMPACT AND NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23830038 ↗
Other Biomet Orthopedics, LLC products
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- STAGEONE17 models · 0 reports · 18 recalls
- StageOne Select15 models · 2 reports · 15 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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