Reported Reactions

Manufacturers

Device manufacturer, as written on reports

Depuy France Sas - 3003895575: medical device reports filed with FDA

4,889 reports name it as the manufacturer of the device involved, 2010–2026.

4,889
reports naming it as manufacturer
0% of all MAUDE reports
75
reports, 12 months to August 2026
77 in the 12 months before
36.2%
classified as malfunction
62.3% across all reports
0.1%
classified as death, as reported
0.9% across all reports

4,889 medical device reports received by FDA give Depuy France Sas - 3003895575 as the manufacturer of the device involved, 0% of the MAUDE database, from January 2010 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

75 reports arrived in the 12 months to August 2026, close to the 77 of 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 (63.6%), malfunction (36.2%) and death (0.1%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."

Brands named most often

BrandDevice typeReportsLatest 12 monthsClassified as death
Locking Screwdriver BodyScrewdriver282170%
Corail2 Std Size 11Prosthesis, hip, semi-constrained (metal uncemented acetabular component)17420.5%
Corail2 Std Size 12Prosthesis, hip, semi-constrained (metal uncemented acetabular component)14430.4%
Corail2 Non Col Ho Size 12Prosthesis, hip, semi-constrained (metal uncemented acetabular component)12420.3%
Corail2 Std Size 10Prosthesis, hip, semi-constrained (metal uncemented acetabular component)10500.3%
Glenosphere Orientation GuideOrthopedic manual surgical instrument105130%
Corail2 Anterior Broach HandleBroach10300%
Corail Amt Collar Size 12Prosthesis, hip, semi-constrained (metal uncemented acetabular component)9620.3%
Dxtend MetagleneProsthesis, shoulder, hemi-, humeral, metallic uncemented85140%
Corail Amt Collar Size 11Prosthesis, hip, semi-constrained (metal uncemented acetabular component)8020%
Rod For Reaming Guide HolderOrthopedic manual surgical instrument7910%
Corail Broach HandleBroach7110%
UNK Hip Femoral Stem CorailProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented65560.8%
Corail Amt Collar Size 10Prosthesis, hip, semi-constrained (metal uncemented acetabular component)6300%
Corail2 Non Col Ho Size 10Prosthesis, hip, semi-constrained (metal uncemented acetabular component)6300%
3 5 Cannulated ScrewdriverScrewdriver6220%
Corail2 Non Col Ho Size 11Prosthesis, hip, semi-constrained (metal uncemented acetabular component)6120%
Corail2 Std Size 9Prosthesis, hip, semi-constrained (metal uncemented acetabular component)5900.4%
Dxtend Glenosphere Std D38mmProsthesis, shoulder, hemi-, humeral, metallic uncemented5750%
Dxtend Stand Pe Cup D38 +3mmProsthesis, shoulder, hemi-, humeral, metallic uncemented5680%
Corail2 Std Size 13Prosthesis, hip, semi-constrained (metal uncemented acetabular component)5501.6%
Corail2 Non Col Ho Size 13Prosthesis, hip, semi-constrained (metal uncemented acetabular component)5410%
Corail2 Std Size 8Prosthesis, hip, semi-constrained (metal uncemented acetabular component)5200%
Dxtend Screw Lock D4 5x36mmProsthesis, shoulder, hemi-, humeral, metallic uncemented52110%
Dxtend Screw Lock D4 5x30mmProsthesis, shoulder, hemi-, humeral, metallic uncemented48120%
Corail Amt Collar Size 13Prosthesis, hip, semi-constrained (metal uncemented acetabular component)3920%
Dxtend Glenosphere Std D42mmProsthesis, shoulder, hemi-, humeral, metallic uncemented3930%
Dxtend Stand Pe Cup D38 +6mmProsthesis, shoulder, hemi-, humeral, metallic uncemented3720%
Unknown Hip Femoral StemProsthesis, hip, semi-constrained, metal/polymer, cemented32790.8%
Dxtend Glenosphere Ecc D38mmProsthesis, shoulder, hemi-, humeral, metallic uncemented3020%

Brands with a page on this site, 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."

Device types

Product codeDevice typeReportsShare
KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)1,53631.4%
HSDProsthesis, shoulder, hemi-, humeral, metallic uncemented60712.4%
HTQBroach4479.1%
LXHOrthopedic manual surgical instrument4138.4%
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented4058.3%
HXXScrewdriver3487.1%
KWSProsthesis, shoulder, semi-constrained, metal/polymer cemented3457.1%
KWLProsthesis, hip, hemi-, femoral, metal911.9%
PHXShoulder prosthesis, reverse configuration911.9%
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented440.9%

Reports by month, five years

01325Sep 2021: 18Oct 2021: 19Nov 2021: 14Dec 2021: 182022Jan 2022: 10Feb 2022: 12Mar 2022: 16Apr 2022: 10May 2022: 19Jun 2022: 18Jul 2022: 16Aug 2022: 10Sep 2022: 16Oct 2022: 3Nov 2022: 25Dec 2022: 82023Jan 2023: 7Feb 2023: 14Mar 2023: 4Apr 2023: 6May 2023: 2Jun 2023: 5Jul 2023: 5Aug 2023: 5Sep 2023: 15Oct 2023: 20Nov 2023: 14Dec 2023: 122024Jan 2024: 7Feb 2024: 23Mar 2024: 10Apr 2024: 6May 2024: 5Jun 2024: 12Jul 2024: 17Aug 2024: 4Sep 2024: 10Oct 2024: 15Nov 2024: 7Dec 2024: 152025Jan 2025: 8Feb 2025: 4Mar 2025: 3Apr 2025: 6May 2025: 2Jun 2025: 3Jul 2025: 2Aug 2025: 2Sep 2025: 1Oct 2025: 2Nov 2025: 0Dec 2025: 92026Jan 2026: 10Feb 2026: 14Mar 2026: 16Apr 2026: 5May 2026: 8Jun 2026: 1Jul 2026: 3Aug 2026: 6

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

Event type

Death0.1%7
Injury63.6%3,111
Malfunction36.2%1,771
Other0%0
Not given0%0

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Depuy France Sas - 3003895575 reports

How many FDA device reports name Depuy France Sas - 3003895575 as manufacturer?

4,889 reports through August 2026, 75 of them in the latest 12 months.

Which of its brands appear most often?

Locking Screwdriver Body (282), Corail2 Std Size 11 (174), Corail2 Std Size 12 (144), Corail2 Non Col Ho Size 12 (124) and Corail2 Std Size 10 (105).

Which device types does it report on?

prosthesis, hip, semi-constrained (metal uncemented acetabular component) (31.4%), prosthesis, shoulder, hemi-, humeral, metallic uncemented (12.4%), broach (9.1%) and orthopedic manual surgical instrument (8.4%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.