Device manufacturer, as written on reports

Depuy Ireland - 9616671: medical device reports filed with FDA

47,664 reports name it as the manufacturer of the device involved, 2011–2026.

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.

47,664
reports naming it as manufacturer: 0.2% of all MAUDE reports; 5,071
reports, 12 months to August 2026: 5,589 in the 12 months before; 51.3%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

47,664 medical device reports received by FDA give Depuy Ireland - 9616671 as the manufacturer of the device involved, 0.2% of the MAUDE database, from March 2011 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

5,071 reports arrived in the 12 months to August 2026, close to the 5,589 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 malfunction (51.3%) and injury (48.6%). 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
Attune Femoral Impactor	Impactor	1,991	121	0%
Attune	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	1,305	1,944	0%
Attune Femoral Introducer	Driver, prosthesis	1,116	202	0%
Attune Fb Tibial Impactor	Impactor	1,112	114	0%
Attune Impaction Handle	Impactor	1,014	64	0%
Attune Rp Tibial Impactor	Impactor	717	32	0%
Attune Spacer Block	Template	629	80	0%
UNK Attune Knee Tibial Insert	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	605	102	0.1%
Attune Fb Tib Base Sz 5 Cem	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	500	18	0%
Attune Fb Tib Base Sz 4 Cem	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	461	14	0%
Attune Rp Tib Base Sz 4 Cem	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	429	7	0%
UNK Hip Femoral Stem Corail	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	418	56	0.8%
UNK Attune Knee Tibial Tray	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	401	50	0%
Attune Rp Tib Base Sz 5 Cem	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	355	7	0%
Modular Calcar Planer Sml	Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment	342	30	0%
UNK Attune Femoral	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	338	79	0.2%
Attune Medial Dome Pat 38mm	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	311	15	0.7%
Attune Mod Post Saw Cap Sz 6-8	Orthopedic manual surgical instrument	289	41	0%
Attune Tibial Trial Extractor	Extractor	289	22	0%
Attune Patella Drill Clamp	Clamp	260	50	0%
Attune Rp Tib Base Sz 7 Cem	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	255	7	0%
Attune Medial Dome Pat 41mm	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	248	14	0%
Attune Medial Dome Pat 35mm	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	241	11	0%
Attune Mes Sizing/Rot Gde	Template	222	36	0%
Attune Distal Femoral Jig	Template	216	24	0%
Attune Fb Tib Base Sz 7 Cem	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	212	13	0.5%
Attune Fb Tib Base Sz 6 Cem	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	210	10	0%
Attune Rp Ps Artic Surf Sz6	Template	201	15	0%
Velys	Orthopedic stereotaxic instrument	195	257	0%
Attune Rp Tib Base Sz 6 Cem	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	193	14	0.3%

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
JWH	Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer	13,123	27.5%
NJL	Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing	7,191	15.1%
HWT	Template	6,729	14.1%
HWA	Impactor	5,489	11.5%
LXH	Orthopedic manual surgical instrument	2,368	5%
HWR	Driver, prosthesis	1,405	2.9%
HTQ	Broach	1,321	2.8%
LPH	Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented	1,084	2.3%
HTO	Reamer	737	1.5%
HSD	Prosthesis, shoulder, hemi-, humeral, metallic uncemented	606	1.3%

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%23

Injury48.6%23,178

Malfunction51.3%24,463

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 - 9616671 reports

How many FDA device reports name Depuy Ireland - 9616671 as manufacturer?

47,664 reports through August 2026, 5,071 of them in the latest 12 months.

Which of its brands appear most often?

Attune Femoral Impactor (1,991), Attune (1,305), Attune Femoral Introducer (1,116), Attune Fb Tibial Impactor (1,112) and Attune Impaction Handle (1,014).

Which device types does it report on?

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (27.5%), prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing (15.1%), template (14.1%) and impactor (11.5%).

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.