Device manufacturer, as written on reports

Depuy France Sas 3003895575: medical device reports filed with FDA

3,049 reports name it as the manufacturer of the device involved, 2011–2023.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

3,049
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 25.4%
classified as malfunction: 62.3% across all reports; 0.2%
classified as death, as reported: 0.9% across all reports

3,049 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 2011 to July 2023. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

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 injury (74.4%), malfunction (25.4%) and death (0.2%). 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

Brand	Device type	Reports	Latest 12 months	Classified as death
Locking Screwdriver Body	Screwdriver	143	17	0%
Corail2 Std Size 11	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	114	2	0.5%
Corail2 Std Size 12	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	113	3	0.4%
Dxtend Glenosphere Std D38mm	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	99	5	0%
Corail2 Std Size 10	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	84	0	0.3%
Corail Amt Collar Size 11	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	71	2	0%
Dxtend Stand Pe Cup D38 +3mm	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	70	8	0%
Dxtend Glenosphere Std D42mm	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	69	3	0%
Dxtend Metaglene	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	69	14	0%
Corail2 Std Size 9	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	66	0	0.4%
Corail2 Non Col Ho Size 12	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	64	2	0.3%
Corail Amt Collar Size 12	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	63	2	0.3%
Dxtend Glenosphere Ecc D38mm	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	53	2	0%
Corail2 Non Col Ho Size 11	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	52	2	0%
Corail Amt Collar Size 10	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	49	0	0%
Corail2 Std Size 8	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	41	0	0%
Glenosphere Orientation Guide	Orthopedic manual surgical instrument	39	13	0%
Corail Broach Handle	Broach	38	1	0%
Corail2 Non Col Ho Size 13	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	38	1	0%
Corail2 Anterior Broach Handle	Broach	36	0	0%
UNK Hip Femoral Stem Corail	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	36	56	0.8%
Dxtend Screw Lock D4 5x36mm	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	31	11	0%
Dxtend Stand Pe Cup D38 +6mm	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	31	2	0%
Corail2 Std Size 13	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	29	0	1.6%
Rod For Reaming Guide Holder	Orthopedic manual surgical instrument	29	1	0%
Corail2 Non Col Ho Size 10	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	28	0	0%
Dxtend Stand Pe Cup D38 +9mm	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	28	5	0%
Dxtend Glenosphere Ecc D42mm	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	27	0	0%
Dxtend Screw Lock D4 5x30mm	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	25	12	0%
Corail2 Lat Coxa Vara Size 11	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	22	1	0.6%

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 code	Device type	Reports	Share
KWA	Prosthesis, hip, semi-constrained (metal uncemented acetabular component)	1,036	34%
HSD	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	640	21%
KWS	Prosthesis, shoulder, semi-constrained, metal/polymer cemented	311	10.2%
LXH	Orthopedic manual surgical instrument	186	6.1%
HTQ	Broach	157	5.1%
HXX	Screwdriver	138	4.5%
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	137	4.5%
KWL	Prosthesis, hip, hemi-, femoral, metal	127	4.2%
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented	75	2.5%
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	19	0.6%

Reports by month, five years

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

Event type

Death0.2%6

Injury74.4%2,268

Malfunction25.4%775

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?

3,049 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Locking Screwdriver Body (143), Corail2 Std Size 11 (114), Corail2 Std Size 12 (113), Dxtend Glenosphere Std D38mm (99) and Corail2 Std Size 10 (84).

Which device types does it report on?

prosthesis, hip, semi-constrained (metal uncemented acetabular component) (34%), prosthesis, shoulder, hemi-, humeral, metallic uncemented (21%), prosthesis, shoulder, semi-constrained, metal/polymer cemented (10.2%) and orthopedic manual surgical instrument (6.1%).

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.