EvolutionRecalls & reported problems across all models
Microport Orthopedics Inc. · 125 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 304
- Deaths reported
- 0
- Injuries reported
- 298
- Recalls
- 0
We found 125 models of Evolution by Microport Orthopedics Inc. in the FDA's device registry (GUDID). Together they are named in 304 adverse event reports in the FDA's MAUDE database, received between May 29, 2019 and Nov 24, 2025 — classified as 298 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (108 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 Evolution problems
Device problems
- Insufficient Device Problem Information108
- Unstable64
- Loss of Osseointegration35
- Appropriate Device Problem Term/Code Not Available26
- Adverse Event Without Identified Device or Use Problem24
- Break19
- Unexpected Therapeutic Results11
- Naturally Worn8
Patient problems
- Unspecified Infection113
- Insufficient Information64
- Pain62
- No Information24
- Inflammation23
- Loss of Range of Motion19
- Fluid Discharge16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
Evolution models
125 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Evolution EIS6S10RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer14 reports
- Evolution EIS5S10LProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer12 reports
- Evolution EIS5S10RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer11 reports
- Evolution ETPKN4SRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer9 reports
- Evolution EIS6S10LProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer8 reports
- Evolution EIS6S12LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- Evolution EIS7S10RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer7 reports
- Evolution ETPKN5SLProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer7 reports
- Evolution ETPKN6SLProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer7 reports
- Evolution EIS7S10LProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer6 reports
- Evolution EFSRN4PRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- Evolution EFSRN5PLProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer5 reports
- Evolution EFSRN5PRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- Evolution EFSRN6PLProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer5 reports
- Evolution EFSRN6PRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- Evolution EIS4P10RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- Evolution EIS4S12LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- Evolution ETPK1556Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer5 reports
- Evolution ETPKN5SRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer5 reports
- Evolution ETPKN7SLProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer5 reports
- Evolution EFSRN4PLProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer4 reports
- Evolution EFSRN7PLProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer4 reports
- Evolution EIS5S12LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer4 reports
- Evolution EIS5S12RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer4 reports
- Evolution ETPKN6SRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer4 reports
- Evolution ETPLB6SLProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer4 reports
- Evolution ETPLB6SRProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer4 reports
- Evolution EIS4S12RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer3 reports
- Evolution EIS4S14RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer3 reports
- Evolution EIS5P10LProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer3 reports
- Evolution EIS5P10RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- Evolution EIS5S14LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- Evolution EIS5S14RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer3 reports
- Evolution EIS6S14LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer3 reports
- Evolution EIS6S14RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer3 reports
- EVOLUTION ETAKN6SLPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Evolution ETPKN4SLProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer3 reports
- EVOLUTION® ETRKMK36PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Evolution EFPSN3PRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- EVOLUTION EFSAN5PRPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- EVOLUTION EFSAN6PLPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Evolution EFSRN7PRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- EVOLUTION EFSRP6PLPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Evolution EIP3S10RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- Evolution EIS4P10LProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2 reports
- Evolution EIS4P12RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2 reports
- Evolution EIS4P17RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2 reports
- Evolution EIS4S10LProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2 reports
- Evolution EIS4S10RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- Evolution EIS6P10RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- Evolution EIS6P12RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2 reports
- Evolution EIS7P10LProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer2 reports
- Evolution EIS7S14LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- Evolution ETPKN3SRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- Evolution ETPKN7SRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 reports
- EVOLUTION® ETRKN6SRPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- EVOLUTION® E5001002CNBIT, SURGICAL1 report
- EVOLUTION® E2000001CNORTHOPEDIC MANUAL SURGICAL INSTRUMENT1 report
- EVOLUTION® E1000010Guide, surgical, instrument1 report
- EVOLUTION® E1000201BIT, SURGICAL1 report
- EVOLUTION® E2004028Guide, surgical, instrument1 report
- EVOLUTION® E310510RTEMPLATE1 report
- Evolution EAI4212LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EAI6412RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- Evolution EFPSN5PLProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- EVOLUTION EFSAN2PLPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- EVOLUTION EFSAN2PRPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- EVOLUTION EFSAN3PLPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- EVOLUTION EFSAN4PRPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Evolution EFSRN2PRProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- EVOLUTION EFSRN5RRPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Evolution EFSRN8PLProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- EVOLUTION EFSRP5PLPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- EVOLUTION EFSRP5PRPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- EVOLUTION EFSRP6PRPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- EVOLUTION EFXSNP5LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- EVOLUTION EFXSNP6LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- EVOLUTION EFXSNP6RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Evolution EIP4S12RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EIP5S10LProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- Evolution EIS3P17RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- Evolution EIS3S10LProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- Evolution EIS3S10RProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EIS3S12LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EIS3S12RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- Evolution EIS4S14LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EIS5P12LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EIS5P12RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- Evolution EIS5P14LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EIS5S17LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EIS5S20RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- Evolution EIS6P12LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EIS6P14RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- Evolution EIS6S17LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EIS6S17RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- Evolution EIS7S12LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EIS7S14RProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- Evolution EIS8S10LProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer1 report
- Evolution EIS8S12LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Evolution EIS8S17LProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
Recent Evolution adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryNov 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(4). SIDE: R. GENDER: M. MPO NON-REVISED PRODUCTS: PRODUCT ID: EFSRN7PR EVOLUTIONL MP FEM CS/CR NON-POROUS SIZE 7 PRIMARY RIGHT/ LOT NO.: 1951833/ QTY: 1. PRODUCT ID: KPONTP35 ADVANCEL ONLAY ALL-POLY PATELLA 35MM TRI-PEG/ LOT NO.: 1936571/ QTY: 1. PRODUCT ID: ETPKN7SR EVOLUTIONL MP TIBIAL BASE KEELED NON-POROUS SIZE 7 STANDARD RIGHT/ LOT NO.: 1948705/ QTY: 1.
Patient problems: Unspecified Infection
MAUDE report 23633136 ↗InjuryNov 20, 2025Unstable; Unstable
ALLEGEDLY, PATIENT UNDERWENT L TKR ON (B)(6) 2022. REVISED ON (B)(6) 2025. THE CAUSE FOR REVISION WAS STABILITY ISSUES, LARGE PATIENT HIGH BMI LIGAMENT LAXITY. (B)(4).
Patient problems: Insufficient Information
MAUDE report 23609761 ↗InjuryNov 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2023. REVISED ON (B)(6) 2025 DUE TO INFECTION. INSERT REVISED WITH ANOTHER OF THE SAME SIZE. (B)(6).
Patient problems: Unspecified Infection
MAUDE report 23486955 ↗InjuryNov 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT UNDERWENT SECOND L TKR REVISION DUE TO INFECTION ON (B)(6) 2025. INSERT REPLACED WITH ANOTHER OF THE SAME SIZE. PRIMARY CASE TOOK PLACE ON (B)(6) 2024. FIRST REVISION DUE TO INFECTION TOOK PLACE ON (B)(6) 2025 ((B)(4)). AUSTRALIA (B)(4).
Patient problems: Unspecified Infection
MAUDE report 23486935 ↗InjuryNov 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2025. REVISED ON (B)(6) 2025 DUE TO SUSPECTED INFECTION. CRP LEVEL POST-OP WAS HIGH, INDICATING POTENTIAL INFECTION. CRP LEVELS DROPPED AFTER WASHOUT & INSERT CHANGE. PATIENT CONFIRMED AS HIGH RISK DUE TO MORBID OBESITY AND OTHER MEDICAL HISTORY. AUSTRALIA-(B)(4).
Patient problems: Unspecified Infection
MAUDE report 23486932 ↗InjurySep 18, 2025Unstable; Unstable
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. SRNJR NUMBER: (B)(6). SIDE: R. GENDER: F.
Patient problems: Insufficient Information
MAUDE report 23089992 ↗InjurySep 18, 2025Unstable; Unstable
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. SRNJR NUMBER: (B)(6), SIDE: R, GENDER: F.
Patient problems: Insufficient Information
MAUDE report 23089988 ↗InjurySep 18, 2025Unstable; Unstable
ALLEGEDLY, PATIENT WAS REVISED DUE TO INSTABILITY. SRNJR NUMBER: (B)(6). SIDE: R. GENDER: F.
Patient problems: Insufficient Information
MAUDE report 23089986 ↗InjurySep 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: L. GENDER: M.
Patient problems: Unspecified Infection
MAUDE report 23089982 ↗InjurySep 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(4), SIDE: L, GENDER: M.
Patient problems: Unspecified Infection
MAUDE report 23062581 ↗InjurySep 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6) SIDE: L GENDER: M.
Patient problems: Unspecified Infection
MAUDE report 23062568 ↗InjurySep 2, 2025Unstable; Unstable
ALLEGEDLY, PATIENT UNDERWENT R TKR ON (B)(6) 2023. REVISED ON (B)(6) 2025 DUE TO INSTABILITY. 10MM INSERT REPLACED WITH A 14MM INSERT. (B)(4).
Patient problems: Insufficient Information
MAUDE report 22935254 ↗InjuryJul 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: R. NON-REVISED PRODUCTS: PRODUCT ID: EFSRN6PR EVOLUTION® MP FEM CS/CR NON-POROUS SIZE 6 PRIMARY RIGHT/ LOT NO.: 2007053/ QTY: 1. PRODUCT ID: ETPKN6SR EVOLUTION® MP TIBIAL BASE KEELED NON-POROUS SIZE 6 STANDARD RIGHT/ LOT NO.: 2030828/ QTY: 1. PRODUCT ID: KPONTP35 ADVANCE® ONLAY ALL-POLY PATELLA 35MM TRI-PEG/ LOT NO.: 20284692032763/ QTY: 1.
Patient problems: Unspecified Infection
MAUDE report 22681604 ↗InjuryJul 7, 2025Unstable; Unstable
ALLEGEDLY, PATIENT UNDERWENT L TKR ON (B)(6) 2023. REVISED ON (B)(6) 2025 DUE TO INSTABILITY. TIBIAL INSERT CHANGED FROM 12MM TO 17MM. AUSTRALIA-C25-157.
Patient problems: Insufficient Information
MAUDE report 22414494 ↗InjuryJun 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
ALLEGEDLY, PATIENT WAS REVISED DUE TO INFECTION. SRNJR NUMBER: (B)(6). SIDE: R GENDER: M NON REVISED PRODUCTS: PRODUCT ID: EFSRN6PR EVOLUTION® MP FEM CS/CR NON-POROUS SIZE 6 PRIMARY RIGHT/ LOT NO: 1984097/ QTY: (B)(4). PRODUCT ID: ETPKN6PR EVOLUTION® MP TIBIAL BASE KEELED NON-POROUS SIZE 6 PLUS RIGHT/ LOT NO.: 1989138/ QTY: (B)(4).
Patient problems: Unspecified Infection
MAUDE report 22178252 ↗
Other Microport Orthopedics Inc. products
All Microport Orthopedics Inc. devices →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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