Reported Reactions

Devices › Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

Device brand name · Prosthesis knee patellofemorotibial semi-constrained cemented polymer/metal

Logic Knee Components: medical device reports filed with FDA

150 reports name it, 2021–2026. Manufacturer given most often on reports: Exactech. Product code JWH.

150
device reports naming the brand
0% of all MAUDE reports · about 31 a year
69
reports, 12 months to August 2026
36 in the 12 months before
7.3%
classified as malfunction
14.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

150 medical device reports received by FDA name the brand "Logic Knee Components" (prosthesis knee patellofemorotibial semi-constrained cemented polymer/metal); the manufacturer given most often on reports is Exactech; received from August 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

69 reports arrived in the 12 months to August 2026, up 92% from 36 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (92.7%) and malfunction (7.3%); across all prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer reports (product code JWH) death is recorded in 0.2% and malfunction in 14.7%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are naturally worn (23.3%), insufficient device problem information (17.3%) and unstable (14%). The patient problems coded most often are pain, failure of implant and joint laxity. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

0611Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 2Oct 2022: 0Nov 2022: 1Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 1Apr 2023: 1May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 2Oct 2023: 0Nov 2023: 1Dec 2023: 12024Jan 2024: 1Feb 2024: 0Mar 2024: 1Apr 2024: 2May 2024: 0Jun 2024: 1Jul 2024: 1Aug 2024: 1Sep 2024: 1Oct 2024: 4Nov 2024: 9Dec 2024: 42025Jan 2025: 1Feb 2025: 4Mar 2025: 2Apr 2025: 0May 2025: 2Jun 2025: 4Jul 2025: 3Aug 2025: 2Sep 2025: 11Oct 2025: 3Nov 2025: 5Dec 2025: 92026Jan 2026: 1Feb 2026: 3Mar 2026: 9Apr 2026: 6May 2026: 2Jun 2026: 8Jul 2026: 4Aug 2026: 8

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

023462021: 2920212022: 320222023: 620232024: 2520242025: 4620252026: 412026

Event type and report source

Event type, as classified on the report

Death0%0
Injury92.7%139
Malfunction7.3%11
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%150
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 158,133 reports carrying product code JWH. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Naturally worn3523.3%6.8%
Insufficient device problem information2617.3%18.1%
Unstable2114%4.3%
Loosening of implant not related to bone-ingrowth2013.3%4%
Mechanical problema mechanical problem85.3%0.5%
Lack of effect32%0.1%
Crackthe device cracked10.7%0.5%
Device dislodged or dislocated10.7%1.7%
Loss of osseointegration10.7%0.9%
Noise, audible10.7%1%
Osseointegration problem10.7%0.3%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Painpain, site not specified4328.7%
Failure of implant3422.7%
Joint laxity2214.7%
Osteolysis2114%
Swelling/ edema1912.7%
Ambulation or postural difficulties149.3%
Appropriate clinical signs, symptoms and conditions term/code not available149.3%
Discomfortdiscomfort96%
Loss of range of motion85.3%
Aseptic loosening64%
Joint effusion64%
Arthrofibrosis53.3%
Implant pain53.3%
Synovitis53.3%
Ankylosis42.7%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureLogic Knee ComponentsProduct code JWHAll MAUDE reports
Reports150158,13326,136,888
Share of that pool—0.1%0%
Classified as death, per 1,000 reports029
Classified as injury92.7%84.1%36.2%
Classified as malfunction7.3%14.7%62.3%
Filed by the manufacturer100%98.4%94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code JWH

BrandReportsLatest 12 monthsClassified as death
Unknown Knee Tibial Insert2,2471300.2%
Unknown Knee Femoral1,897650.2%
Unknown Knee Tibial Tray1,958570.2%
Persona Tibial Articular Surface Provisional1,58400%
Itotal G21,25000%
Specific Device Not Reported1,462200.2%
Apex Knee System1,001490%
Djo Surgical4,7132,4480%
Unknown Knee1,847181.5%
Attune Fb Tib Base Sz 5 Cem863180%
Attune Fb Tib Base Sz 4 Cem797140%
Pfc Sigma/Ov/Dome Pat 3peg 3880630.4%
Unknown Knee Patella791260.4%
Unknown Reconstructive Product2,57900.4%
UNK Attune Knee Tibial Insert8951020.1%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Logic Knee Components reports

How many FDA reports name Logic Knee Components?

150 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 69 in the latest 12 months.

What kinds of events are reported?

injury (92.7%) and malfunction (7.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

naturally worn (23.3%), insufficient device problem information (17.3%), unstable (14%), loosening of implant not related to bone-ingrowth (13.3%) and mechanical problem (5.3%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Logic Knee Components was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.