PERSONARecalls & reported problems across all models
Zimmer, Inc. · 364 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,000
- Deaths reported
- 0
- Injuries reported
- 1,149
- Recalls
- 3
We found 364 models of PERSONA by Zimmer, Inc. in the FDA's device registry (GUDID). Together they are named in 2,000 adverse event reports in the FDA's MAUDE database, received between Apr 17, 2019 and Sep 30, 2026 — classified as 1,149 injuries, 851 malfunctions.
The most frequently reported specific device problem is “Fracture” (662 reports).
3 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 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-1808-2018 · 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-1807-2018 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 5, 2017Terminated
Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.
Z-0349-2018 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗
Most reported PERSONA problems
Device problems
- Adverse Event Without Identified Device or Use Problem830
- Fracture662
- Loosening of Implant Not Related to Bone-Ingrowth149
- Unstable48
- Detachment of Device or Device Component42
- Packaging Problem41
- Insufficient Device Problem Information31
- Difficult to Insert28
Patient problems
- No Clinical Signs, Symptoms or Conditions809
- Pain662
- Loss of Range of Motion277
- Swelling/ Edema233
- Failure of Implant147
- Scar Tissue122
- Ambulation or Postural Difficulties109
- Adhesion(s)84
PERSONA models
364 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- PERSONA™ 42-5099-094-00PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- PERSONA® 42-5570-001-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER75 reports
- PERSONA™ 42-5099-093-00PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER72 reports
- Persona® 42-5781-008-01PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- Persona® 42-5781-008-02PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall0 reports
- PERSONA® 42-5399-083-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- PERSONA® 42-5399-083-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- Persona® 42-5600-075-14PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER46 reports
- PERSONA™ 42-5400-000-35PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER30 reports
- PERSONA™ 42-5400-000-32PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER26 reports
- PERSONA® 42-5400-000-35PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER22 reports
- PERSONA® 42-5299-001-00PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER21 reports
- PERSONA® 42-5026-062-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER20 reports
- Persona® 42-5099-090-00IMPACTOR18 reports
- PERSONA® 42-5026-068-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER18 reports
- PERSONA® 42-5026-068-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER18 reports
- PERSONA® 42-5006-064-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- PERSONA® 42-5026-070-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- PERSONA® 42-5400-000-32PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- PERSONA® 42-5026-066-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- PERSONA® 42-5400-000-29PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- PERSONA® 42-5020-060-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- PERSONA® 42-5020-064-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- PERSONA® 42-5026-066-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- PERSONA® 42-5020-062-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- PERSONA® 42-5020-060-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- PERSONA® 42-5026-058-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- PERSONA™ 42-5400-000-29PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- Persona® 42-5566-062-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive13 reports
- Persona® 42-5420-075-01Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive13 reports
- PERSONA® 42-5006-062-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- PERSONA® 42-5026-062-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- PERSONA® 42-5026-064-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- PERSONA® 42-5026-070-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- Persona® 42-5420-071-02PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER12 reports
- Persona® 42-5399-090-00IMPACTOR11 reports
- PERSONA® 42-5000-062-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- PERSONA® 42-5020-064-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- Persona® 42-5181-007-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER10 reports
- PERSONA® 42-5006-066-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- PERSONA® 42-5399-022-05PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- PERSONA™ 42-5400-000-38PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- Persona® 42-5566-062-05Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive10 reports
- Persona® 42-5603-135-13PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- PERSONA® 42-5000-064-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- PERSONA® 42-5006-060-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- PERSONA® 42-5020-068-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- PERSONA® 42-5026-064-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- Persona® 42-5568-062-05Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive9 reports
- Persona® 42-5046-058-02PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER9 reports
- Persona® 42-5046-062-02Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive9 reports
- Persona® 42-5046-070-01PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER9 reports
- Persona® 42-5181-006-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER8 reports
- PERSONA® 42-5000-064-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- PERSONA® 42-5006-064-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- PERSONA® 42-5006-066-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- PERSONA® 42-5020-066-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- PERSONA® 42-5020-066-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- PERSONA® 42-5026-058-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- PERSONA™ 42-5099-092-00PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- Persona® 42-5046-062-12PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER8 reports
- Persona® 42-5606-135-15PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- PERSONA® 42-5000-060-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- PERSONA® 42-5006-068-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- PERSONA® 42-5006-068-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- PERSONA® 42-5171-009-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- Persona® 42-5566-058-05PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER7 reports
- Persona® 42-5568-070-05PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER7 reports
- Persona® 42-5420-071-01Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive7 reports
- Persona® 42-5420-067-02Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive7 reports
- Persona® 42-5420-075-02PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER7 reports
- Persona® 00-5901-035-48ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- PERSONA® 42-5400-000-38PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- Persona® 42-5399-051-85PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER6 reports
- Persona® 42-5601-135-16Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive6 reports
- PERSONA® 42-5000-060-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- PERSONA® 42-5006-070-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- PERSONA® 42-5006-070-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- PERSONA® 42-5026-060-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- PERSONA® 42-5026-074-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- Persona® 42-5279-004-04PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- Persona® 42-5046-070-02Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive6 reports
- Persona® 42-5420-067-01PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER6 reports
- Persona® 42-5420-079-01PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER6 reports
- Persona® 42-5181-007-10PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- Persona® 42-5181-008-08PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- Persona® 42-5601-135-14PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- PERSONA® 42-5006-058-02PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- PERSONA® 42-5020-058-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- PERSONA® 42-5020-062-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- PERSONA® 42-5026-074-01PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- PERSONA® 42-5271-008-10PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- PERSONA® 42-5271-009-10PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER5 reports
- Persona® 42-5566-066-05PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER5 reports
- Persona® 42-5566-070-05PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER5 reports
- Persona® 42-5566-058-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive5 reports
- Persona® 42-5566-070-10Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive5 reports
- Persona® 42-5568-066-05PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER5 reports
- Persona® 42-5558-034-05Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer + additive5 reports
- Persona® 42-5558-053-05PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER5 reports
Recent PERSONA 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 50952622 ↗MalfunctionSep 30, 2026Packaging Problem
It was reported the implant packaging was found melted; sterility deemed compromised by the reporter. Attempts have been made, and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947214 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient underwent an initial knee surgery. Subsequently, the patient underwent an additional surgery due to pain approximately 3 years post-op. No devices were revised however, a patella implant was placed. It was noted that the patient's BMI was a contributing factor. Attempts have been made and all available information has been provided.
Patient problems: Pain
MAUDE report 50944759 ↗MalfunctionSep 29, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940914 ↗MalfunctionSep 29, 2026Packaging Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938127 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bone Fracture(s); Damage to Ligament(s)
MAUDE report 50919300 ↗MalfunctionSep 28, 2026Fracture
It was reported that the femoral impactor pad broke. The breakage was discovered after the surgery. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916350 ↗MalfunctionSep 28, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916333 ↗MalfunctionSep 25, 2026Fracture
It was reported that a crack and hole were identified in an impactor pad. The issue was discovered by the sterilization department. Attempts have been made and no further information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900021 ↗MalfunctionSep 24, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884340 ↗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 50867513 ↗MalfunctionSep 22, 2026Fracture
It was reported that the femoral impactor broke during surgery. The surgical technique was utilized. There was no surgical delay. No foreign bodies were retained. Attempts have been made and all available information has been provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858103 ↗MalfunctionSep 18, 2026Device Contamination with Chemical or Other Material; Packaging Problem
It was reported during knee arthroplasty that when the femoral component was opened, the inner packaging was melted and plastic residue was stuck to the implant. The outer packaging appeared normal on the outside, but appeared burnt on the inside. As there was no additional implant available, it was still used to complete the procedure.No adverse events were reported as a result of this malfunction.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819628 ↗MalfunctionSep 18, 2026Fracture
It was reported the femoral impactor pad cracked and broke. There was no consequences or impact to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50816956 ↗InjurySep 16, 2026Loosening of Implant Not Related to Bone-Ingrowth
No further event information available at the time of this report.
Patient problems: Aseptic loosening; Pain; Swelling/ Edema
MAUDE report 50794030 ↗
Other Zimmer, Inc. products
- 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
- 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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