Reported Reactions

Manufacturers

Device manufacturer, as written on reports

Depuy Ireland: medical device reports filed with FDA

5,305 reports name it as the manufacturer of the device involved, 2009–2026.

5,305
reports naming it as manufacturer
0% of all MAUDE reports
818
reports, 12 months to August 2026
863 in the 12 months before
42.8%
classified as malfunction
62.3% across all reports
0%
classified as death, as reported
0.9% across all reports

5,305 medical device reports received by FDA give Depuy Ireland as the manufacturer of the device involved, 0% of the MAUDE database, from February 2009 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

818 reports arrived in the 12 months to August 2026, close to the 863 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 (57.2%) and malfunction (42.8%). 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
Velys Saw Interface LeftOrthopedic stereotaxic instrument4951250%
Velys Saw Interface RightOrthopedic stereotaxic instrument4791240%
Velys Satellite StationOrthopedic stereotaxic instrument277940%
Velys Saw HandpieceOrthopedic stereotaxic instrument195820%
Mbt Cem Keel Tib Tray Sz3Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing14490%
Mbt Cem Keel Tib Tray Sz2 5Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing8160%
Mbt Cem Keel Tib Tray Sz4Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing7540%
Pfc Sigma/Ov/Dome Pat 3peg 38Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer6530.4%
VelysOrthopedic stereotaxic instrument572570%
AttuneProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer561,9440%
Pfc Sigma/Ov/Dome Pat 3peg 41Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer4840%
Pfc Sigma/Ov/Dome Pat 3peg 35Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer4700.2%
Mbt Cem Keel Tib Tray Sz5Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing4330%
Sig Mod Tib Tray Cem Cocr 4Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer4320.3%
Mbt Cem Keel Tib Tray Sz2Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing4130%
Sig Mod Tib Tray Cem Cocr 3Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer4030%
Srom Stm St 36+8l Nk 18x13x160Prosthesis, hip, semi-constrained, metal/polymer, cemented3810%
Pfc Sigmarp Stb Tb In 4 10 0Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing3750%
Pfc Sigmarp Stb Tb In 5 10 0Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing3400%
Srom Stm St 36+6l Nk 11x16x150Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented3410%
Pfc Sigmarp Stb Tb In 3 10 0Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing3020%
Pfc Sigma/Ov Dome Pat 3 Peg 32Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer2900%
Srom Stm Std 36+12l 13x18Prosthesis, hip, semi-constrained, metal/polymer, cemented2800.3%
InhanceOrthopedic manual surgical instrument275890%
Mbt Cem Tibial Tray Sz3Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing2600%
Sig Mod Tib Tray Cem Cocr 2 5Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer2620.2%
Asr Xl Tap Slv Adap 12/14+2Prosthesis, hip, semi-constrained (metal uncemented acetabular component)2400%
Glenosphere Inserter TipOrthopedic manual surgical instrument241750%
Pfc Sigmarp Cv Tb/In S3 10 0Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1920%
Attune Femoral IntroducerDriver, prosthesis162020%

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
OLOOrthopedic stereotaxic instrument1,66031.3%
NJLProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1,17322.1%
JWHProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer87416.5%
LPHProsthesis, hip, semi-constrained, metal/polymer, porous uncemented2324.4%
HWTTemplate2083.9%
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented1743.3%
KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)1392.6%
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1232.3%
MRAProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented1112.1%
LXHOrthopedic manual surgical instrument791.5%

Reports by month, five years

086172Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 52022Jan 2022: 0Feb 2022: 0Mar 2022: 3Apr 2022: 9May 2022: 33Jun 2022: 29Jul 2022: 15Aug 2022: 14Sep 2022: 1Oct 2022: 20Nov 2022: 22Dec 2022: 252023Jan 2023: 9Feb 2023: 4Mar 2023: 22Apr 2023: 14May 2023: 10Jun 2023: 16Jul 2023: 26Aug 2023: 23Sep 2023: 48Oct 2023: 31Nov 2023: 52Dec 2023: 332024Jan 2024: 52Feb 2024: 68Mar 2024: 52Apr 2024: 52May 2024: 58Jun 2024: 47Jul 2024: 52Aug 2024: 53Sep 2024: 40Oct 2024: 85Nov 2024: 64Dec 2024: 1032025Jan 2025: 60Feb 2025: 28Mar 2025: 30Apr 2025: 51May 2025: 146Jun 2025: 119Jul 2025: 74Aug 2025: 63Sep 2025: 58Oct 2025: 116Nov 2025: 172Dec 2025: 1242026Jan 2026: 50Feb 2026: 30Mar 2026: 86Apr 2026: 32May 2026: 25Jun 2026: 58Jul 2026: 36Aug 2026: 31

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

Event type

Death0%0
Injury57.2%3,034
Malfunction42.8%2,270
Other0%1
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 reports

How many FDA device reports name Depuy Ireland as manufacturer?

5,305 reports through August 2026, 818 of them in the latest 12 months.

Which of its brands appear most often?

Velys Saw Interface Left (495), Velys Saw Interface Right (479), Velys Satellite Station (277), Velys Saw Handpiece (195) and Mbt Cem Keel Tib Tray Sz3 (144).

Which device types does it report on?

orthopedic stereotaxic instrument (31.3%), prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing (22.1%), prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (16.5%) and prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (4.4%).

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.