Device manufacturer, as written on reports

Depuy Ireland - 3015516266: medical device reports filed with FDA

9,919 reports name it as the manufacturer of the device involved, 2021–2026.

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.

9,919
reports naming it as manufacturer: 0% of all MAUDE reports; 3,517
reports, 12 months to August 2026: 2,632 in the 12 months before; 69.5%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

9,919 medical device reports received by FDA give Depuy Ireland - 3015516266 as the manufacturer of the device involved, 0% of the MAUDE database, from January 2021 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

3,517 reports arrived in the 12 months to August 2026, up 34% from 2,632 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 (69.5%) and injury (30.5%). 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
Glenosphere Inserter Tip	Orthopedic manual surgical instrument	787	175	0%
Inhance	Orthopedic manual surgical instrument	557	589	0%
Baseplate Inserter Rod	Orthopedic manual surgical instrument	547	105	0%
Concave Impactor Tip	Impactor	332	18	0%
Attune	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	235	1,944	0%
Emphasys	Impactor	202	345	0%
Driver	Driver, prosthesis	186	27	0%
Star Driver 20	Driver, prosthesis	185	57	0%
Emsys Ace Imp Straight	Impactor	169	73	0%
Offset Taper Adapter Trial	Template	160	40	0%
Unknown Bone Cement	Bone cement	78	37	0%
Smartset Gmv 40g Us Eo	Bone cement	65	40	0%
Quickset Ratchet Scdr Hdl	Screwdriver	44	29	0%
Pinnacle	Impactor	37	499	0.1%
Smartset Ghv Gentamicin 40g	Bone cement	36	40	0.4%
Universal Stem Insert Handle	Orthopedic manual surgical instrument	26	24	0%
Smartset Mv 40g - Eo	Bone cement	24	4	0.1%
Actis	Broach	22	214	0%
Depuy Cmw 1 40g	Bone cement	21	0	1.3%
Depuy Cmw 2 20g	Bone cement	21	15	0%
Smartset Hv Bone Cement 40g	Bone cement	19	3	0%
Delta Xtend	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	16	205	0%
Sigma Hp Fbt Keel Punch Impact	Impactor	3	0	0%

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
LXH	Orthopedic manual surgical instrument	1,993	20.1%
HWT	Template	1,308	13.2%
HWA	Impactor	1,060	10.7%
PHX	Shoulder prosthesis, reverse configuration	729	7.3%
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	723	7.3%
HWR	Driver, prosthesis	641	6.5%
FSM	Tray, surgical, instrument	473	4.8%
MBF	Prosthesis, shoulder, semi-constrained, metal/polymer, uncemented	459	4.6%
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	399	4%
LOD	Bone cement	167	1.7%

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

Injury30.5%3,021

Malfunction69.5%6,896

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 Ireland - 3015516266 reports

How many FDA device reports name Depuy Ireland - 3015516266 as manufacturer?

9,919 reports through August 2026, 3,517 of them in the latest 12 months.

Which of its brands appear most often?

Glenosphere Inserter Tip (787), Inhance (557), Baseplate Inserter Rod (547), Concave Impactor Tip (332) and Attune (235).

Which device types does it report on?

orthopedic manual surgical instrument (20.1%), template (13.2%), impactor (10.7%) and shoulder prosthesis, reverse configuration (7.3%).

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.