PERSONA Vivacit-ERecalls & reported problems across all models
Zimmer, Inc. · 285 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,152
- Deaths reported
- 0
- Injuries reported
- 874
- Recalls
- 0
We found 285 models of PERSONA Vivacit-E by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 1,152 adverse event reports in the FDA's MAUDE database, received between Apr 17, 2019 and Sep 30, 2026 — classified as 874 injuries, 278 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (152 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 Vivacit-E problems
Device problems
- Adverse Event Without Identified Device or Use Problem667
- Difficult to Insert152
- Positioning Failure85
- Unstable61
- Fracture35
- Insufficient Device Problem Information30
- Device Contaminated During Manufacture or Shipping22
- Naturally Worn22
Patient problems
- Pain387
- No Clinical Signs, Symptoms or Conditions270
- Loss of Range of Motion227
- Joint Laxity130
- Swelling/ Edema128
- Scar Tissue114
- Failure of Implant97
- Ambulation or Postural Difficulties79
PERSONA Vivacit-E models
285 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- PERSONA® Vivacit-E® 42-5221-008-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER43 reports
- PERSONA® Vivacit-E® 42-5402-000-29Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive41 reports
- PERSONA® Vivacit-E® 42-5402-000-32Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive40 reports
- PERSONA® Vivacit-E® 42-5402-000-35PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER33 reports
- PERSONA® Vivacit-E® 42-5121-008-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive32 reports
- PERSONA® Vivacit-E® 42-5221-009-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive29 reports
- PERSONA® Vivacit-E® 42-5121-009-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER22 reports
- PERSONA® Vivacit-E® 42-5221-008-12Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive20 reports
- PERSONA® Vivacit-E® 42-5220-004-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive18 reports
- PERSONA® Vivacit-E® 42-5124-007-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER17 reports
- PERSONA® Vivacit-E® 42-5220-005-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER17 reports
- PERSONA® Vivacit-E® 42-5221-004-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive17 reports
- PERSONA® Vivacit-E® 42-5120-004-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive16 reports
- PERSONA® Vivacit-E® 42-5402-000-38PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- PERSONA® Vivacit-E® 42-5224-007-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive15 reports
- PERSONA® Vivacit-E® 42-5221-009-11PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- PERSONA® Vivacit-E® 42-5121-007-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER14 reports
- PERSONA® Vivacit-E® 42-5121-008-11Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive14 reports
- PERSONA® Vivacit-E® 42-5224-007-11PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- PERSONA® Vivacit-E® 42-5121-008-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- PERSONA® Vivacit-E® 42-5221-007-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive12 reports
- PERSONA® Vivacit-E® 42-5221-008-11PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER12 reports
- PERSONA® Vivacit-E® 42-5120-005-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- PERSONA® Vivacit-E® 42-5121-004-11PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- PERSONA® Vivacit-E® 42-5226-007-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- PERSONA® Vivacit-E® 42-5221-004-11PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- PERSONA® Vivacit-E® 42-5121-004-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive10 reports
- PERSONA® Vivacit-E® 42-5221-003-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER9 reports
- PERSONA® Vivacit-E® 42-5221-003-11PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER9 reports
- PERSONA® Vivacit-E® 42-5221-004-12Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive9 reports
- PERSONA® Vivacit-E® 42-5221-008-13PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER9 reports
- PERSONA® Vivacit-E® 42-5220-006-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- PERSONA® Vivacit-E® 42-5224-008-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- PERSONA® Vivacit-E® 42-5221-009-12Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive8 reports
- PERSONA® Vivacit-E® 42-5121-003-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- PERSONA® Vivacit-E® 42-5121-007-11PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER8 reports
- Persona® Vivacit-E® 42-5228-007-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER8 reports
- PERSONA® Vivacit-E® 42-5122-005-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive7 reports
- PERSONA® Vivacit-E® 42-5124-005-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER7 reports
- PERSONA® Vivacit-E® 42-5224-005-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- PERSONA® Vivacit-E® 42-5224-009-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER7 reports
- PERSONA® Vivacit-E® 42-5226-007-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- PERSONA® Vivacit-E® 42-5402-000-26PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER7 reports
- PERSONA® Vivacit-E® 42-5221-005-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive7 reports
- PERSONA® Vivacit-E® 42-5121-004-12Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive7 reports
- PERSONA® Vivacit-E® 42-5124-005-11PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER6 reports
- PERSONA® Vivacit-E® 42-5126-005-12Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive6 reports
- PERSONA® Vivacit-E® 42-5126-007-12PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER6 reports
- PERSONA® Vivacit-E® 42-5222-005-11PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER6 reports
- PERSONA® Vivacit-E® 42-5221-007-12PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER6 reports
- PERSONA® Vivacit-E® 42-5221-009-13Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive6 reports
- PERSONA® Vivacit-E® 42-5124-007-11PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER5 reports
- PERSONA® Vivacit-E® 42-5124-007-12Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive5 reports
- PERSONA® Vivacit-E® 42-5222-005-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER5 reports
- PERSONA® Vivacit-E® 42-5222-006-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- PERSONA® Vivacit-E® 42-5226-007-14PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER5 reports
- PERSONA® Vivacit-E® 42-5221-010-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive5 reports
- PERSONA® Vivacit-E® 42-5121-008-13PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER5 reports
- PERSONA® Vivacit-E® 42-5121-008-16PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER5 reports
- PERSONA® Vivacit-E® 42-5121-009-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- PERSONA® Vivacit-E® 42-5120-004-12Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- PERSONA® Vivacit-E® 42-5120-005-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5122-005-13PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5124-008-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5126-010-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5220-005-12Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- PERSONA® Vivacit-E® 42-5224-004-12Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- PERSONA® Vivacit-E® 42-5224-005-11Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- PERSONA® Vivacit-E® 42-5224-007-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5226-005-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5226-008-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5221-004-13Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- PERSONA® Vivacit-E® 42-5221-004-14Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- PERSONA® Vivacit-E® 42-5221-005-11Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- PERSONA® Vivacit-E® 42-5221-007-11Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- PERSONA® Vivacit-E® 42-5221-007-14Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- PERSONA® Vivacit-E® 42-5221-008-16Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- PERSONA® Vivacit-E® 42-5121-003-11PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5121-003-12PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5121-005-11PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5121-007-12PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5121-009-11Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive4 reports
- PERSONA® Vivacit-E® 42-5121-009-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5121-010-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- Persona® Vivacit-E® 42-5228-007-12PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- PERSONA® Vivacit-E® 42-5120-004-11PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Vivacit-E® 42-5120-006-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Vivacit-E® 42-5122-006-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive3 reports
- PERSONA® Vivacit-E® 42-5122-006-11Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive3 reports
- PERSONA® Vivacit-E® 42-5124-004-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Vivacit-E® 42-5124-005-13Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive3 reports
- PERSONA® Vivacit-E® 42-5124-007-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Vivacit-E® 42-5126-007-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Vivacit-E® 42-5126-007-14PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Vivacit-E® 42-5126-007-16PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Vivacit-E® 42-5126-010-14PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Vivacit-E® 42-5220-004-13PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Vivacit-E® 42-5220-005-11PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Vivacit-E® 42-5222-005-13PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- PERSONA® Vivacit-E® 42-5224-004-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
Recent PERSONA Vivacit-E adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture
Patient problems: Joint Laxity; Pain
MAUDE report 50947301 ↗MalfunctionSep 29, 2026Difficult to Insert
It was reported that during a knee arthroplasty an articular surface would not seat into the tibial baseplate despite multiple attempts. Attempts have been made, and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935109 ↗InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Joint Laxity; Pain
MAUDE report 50934099 ↗InjurySep 29, 2026Fracture
Patient problems: Pain
MAUDE report 50932078 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bone Fracture(s); Damage to Ligament(s)
MAUDE report 50919287 ↗MalfunctionSep 25, 2026Device Contaminated During Manufacture or Shipping
It was reported that a hair was observed inside the sterile package. There was no patient involvement. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896920 ↗MalfunctionSep 24, 2026Packaging Problem
It was reported the polyethylene insert packaging was warped, it is believed due to extreme heat. It was noticed during surgery, this device was not used, and a second poly was used instead, the surgical technique was utilized 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 50885867 ↗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 50867519 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Arthrofibrosis
MAUDE report 50858448 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent a revision knee surgery due to instability approximately 7 months post-implantation with exchange of the polyethylene insert. Attempts have been made and no further information has been provided.
Patient problems: Joint Laxity
MAUDE report 50854090 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent an initial right surgery. Subsequently, 2.5 years post-implantation a revision was performed due to instability. The articular surface was exchanged. Attempts have been made and no further information has been provided.
Patient problems: Joint Laxity
MAUDE report 50853366 ↗InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem
It was reported that a patient underwent an initial TKA. Subsequently, the patient had their poly revised due to instability about 2.5 years postop. Attempts have been made and no further information has been provided.
Patient problems: Joint Laxity; Pain
MAUDE report 50499895 ↗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 50495785 ↗MalfunctionAug 24, 2026Device Contaminated During Manufacture or Shipping
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50415823 ↗MalfunctionAug 24, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50411087 ↗
Other Zimmer, Inc. products
- PERSONA364 models · 2,000 reports · 3 recalls
- Persona The Personalized Knee77 models · 1,396 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
- 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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