Reported Reactions

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

Device brand name · Instrument knee

Tibial Articular Surface Provisional Left Size Gh: medical device reports filed with FDA

252 reports name it, 2017–2024. Manufacturer given most often on reports: Zimmer Biomet. Product code JWH.

252
device reports naming the brand
0% of all MAUDE reports · about 27 a year
0
reports, 12 months to August 2026
0 in the 12 months before
99.2%
classified as malfunction
14.7% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 252 reports that name the brand "Tibial Articular Surface Provisional Left Size Gh" (instrument knee), received between January 2017 and May 2024; the manufacturer given most often on reports is Zimmer Biomet. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 malfunction (99.2%) and injury (0.8%); 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 fracture (93.3%), naturally worn (1.6%) and corroded (0.4%). The patient problems coded most often are no patient involvement. 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

059Sep 2021: 0Oct 2021: 3Nov 2021: 4Dec 2021: 62022Jan 2022: 2Feb 2022: 2Mar 2022: 2Apr 2022: 7May 2022: 7Jun 2022: 3Jul 2022: 4Aug 2022: 4Sep 2022: 1Oct 2022: 4Nov 2022: 5Dec 2022: 32023Jan 2023: 1Feb 2023: 8Mar 2023: 7Apr 2023: 3May 2023: 0Jun 2023: 6Jul 2023: 3Aug 2023: 4Sep 2023: 3Oct 2023: 6Nov 2023: 2Dec 2023: 92024Jan 2024: 5Feb 2024: 3Mar 2024: 3Apr 2024: 2May 2024: 1Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

027542017: 620172018: 1120182019: 3120192020: 5420202021: 4020212022: 4420222023: 5220232024: 142024

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.8%2
Malfunction99.2%250
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%252
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
Fracturea broken bone23593.3%7.3%
Naturally worn41.6%6.8%
Corrodedthe device corroded10.4%0.1%
Mechanical jam10.4%0.1%
Separation failure10.4%0%

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
No patient involvement4216.7%

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

In context

MeasureTibial Articular Surface Provisional Left Size GhProduct code JWHAll MAUDE reports
Reports252158,13326,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports029
Classified as injury0.8%84.1%36.2%
Classified as malfunction99.2%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 Tibial Articular Surface Provisional Left Size Gh reports

How many FDA reports name Tibial Articular Surface Provisional Left Size Gh?

252 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (99.2%) and injury (0.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

fracture (93.3%), naturally worn (1.6%), corroded (0.4%), mechanical jam (0.4%) and separation failure (0.4%). 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 Tibial Articular Surface Provisional Left Size Gh 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.