Reported Reactions

Manufacturers

Device manufacturer, as written on reports

Depuy Ireland 9616671: medical device reports filed with FDA

10,088 reports name it as the manufacturer of the device involved, 2011–2023.

10,088
reports naming it as manufacturer
0% of all MAUDE reports
0
reports, 12 months to August 2026
0 in the 12 months before
25.8%
classified as malfunction
62.3% across all reports
0%
classified as death, as reported
0.9% across all reports

10,088 medical device reports received by FDA give Depuy Ireland 9616671 as the manufacturer of the device involved, 0% of the MAUDE database, from March 2011 to June 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 (74.1%) and malfunction (25.8%). 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
Attune Femoral ImpactorImpactor2491210%
Attune Impaction HandleImpactor242640%
Mbt Cem Keel Tib Tray Sz3Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing22090%
Attune Fb Tib Base Sz 5 CemProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer213180%
Attune Fb Tib Base Sz 4 CemProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer184140%
Attune Fb Tibial ImpactorImpactor1551140%
Mbt Cem Keel Tib Tray Sz2 5Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing14160%
Mbt Cem Keel Tib Tray Sz4Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing13740%
Attune Rp Tib Base Sz 5 CemProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing12770%
Delta Cer Head 12/14 36mm +1 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented125590%
Attune Fb Tib Base Sz 6 CemProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer117100%
Attune Fb Tib Base Sz 7 CemProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer105130.5%
Attune Rp Tib Base Sz 4 CemProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing10570%
Delta Cer Head 12/14 36mm +5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented102470%
Sig Mod Tib Tray Cem Cocr 3Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer10230%
Attune Fb Tib Base Sz 3 CemProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer9890%
Delta Cer Head 12/14 32mm +1Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented95390%
Attune Femoral IntroducerDriver, prosthesis902020%
Attune Rp Tib Base Sz 7 CemProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing8670%
Pfc Sigma/Ov/Dome Pat 3peg 38Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer8030.4%
Mbt Cem Keel Tib Tray Sz5Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing7830%
Attune Rp Tibial ImpactorImpactor74320%
Attune Rp Tib Base Sz 6 CemProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing69140.3%
Attune Fb Tib Base Sz 8 CemProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer6850%
Srom Stm St 36+8l Nk 18x13x160Prosthesis, hip, semi-constrained, metal/polymer, cemented6610%
Sig Mod Tib Tray Cem Cocr 4Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer6320.3%
Sig Mod Tib Tray Cem Cocr 2 5Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer6020.2%
Attune Rp Tib Base Sz 3 CemProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing5520%
Attune Spacer BlockTemplate54800%
Attune Rp Tib Base Sz 8 CemProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing5140%

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
JWHProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer3,08830.6%
NJLProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing2,55125.3%
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented7937.9%
HWAImpactor7497.4%
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented5015%
LXHOrthopedic manual surgical instrument3203.2%
HWTTemplate3023%
LPHProsthesis, hip, semi-constrained, metal/polymer, porous uncemented2802.8%
MRAProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented2412.4%
KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)2172.2%

Reports by month, five years

01529Sep 2021: 6Oct 2021: 6Nov 2021: 12Dec 2021: 142022Jan 2022: 29Feb 2022: 9Mar 2022: 0Apr 2022: 2May 2022: 2Jun 2022: 1Jul 2022: 19Aug 2022: 12Sep 2022: 5Oct 2022: 4Nov 2022: 5Dec 2022: 82023Jan 2023: 11Feb 2023: 4Mar 2023: 7Apr 2023: 5May 2023: 2Jun 2023: 5Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 0Feb 2024: 0Mar 2024: 0Apr 2024: 0May 2024: 0Jun 2024: 0Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

Event type

Death0%4
Injury74.1%7,478
Malfunction25.8%2,606
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?

10,088 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Attune Femoral Impactor (249), Attune Impaction Handle (242), Mbt Cem Keel Tib Tray Sz3 (220), Attune Fb Tib Base Sz 5 Cem (213) and Attune Fb Tib Base Sz 4 Cem (184).

Which device types does it report on?

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (30.6%), prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing (25.3%), prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (7.9%) and impactor (7.4%).

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.