Reported Reactions

Manufacturers

Device manufacturer, as written on reports

9616671 Depuy Ireland: medical device reports filed with FDA

1,505 reports name it as the manufacturer of the device involved, 2013–2017.

1,505
reports naming it as manufacturer
0% of all MAUDE reports
0
reports, 12 months to August 2026
0 in the 12 months before
0.2%
classified as malfunction
62.3% across all reports
0.1%
classified as death, as reported
0.9% across all reports

1,505 medical device reports received by FDA give 9616671 Depuy Ireland as the manufacturer of the device involved, 0% of the MAUDE database, from January 2013 to January 2017. 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 (99.7%), malfunction (0.2%) and death (0.1%). 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
Mbt Cem Keel Tib Tray Sz3Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing6390%
Mbt Cem Keel Tib Tray Sz2 5Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing4360%
Delta Cer Head 12/14 36mm +1 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented41590%
Mbt Cem Keel Tib Tray Sz4Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing3740%
Delta Cer Head 12/14 36mm +5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented32470%
Sig Mod Tib Tray Cem Cocr 3Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer3030%
Pfc Sigma/Ov/Dome Pat 3peg 38Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer2830.4%
Delta Cer Head 12/14 32mm +1Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented27390%
Mbt Cem Keel Tib Tray Sz2Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing2530%
Srom Stm St 36+8l Nk 18x13x160Prosthesis, hip, semi-constrained, metal/polymer, cemented2310%
Pfc Sigma/Ov/Dome Pat 3peg 35Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer1900.2%
Sig Mod Tib Tray Cem Cocr 2 5Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer1820.2%
Sig Mod Tib Tray Cem Cocr 4Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer1820.3%
Pfc Sigma/Ov/Dome Pat 3peg 41Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer1740%
Mbt Cem Keel Tib Tray Sz5Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1530%
Pfc Sigmarp Stb Tb In 4 12 5Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1200%
Dlt Ts Cer Hd 12/14 36mm +8 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1190.5%
Pfc Sigmarp Stb Tb In 3 10 0Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1120%
Pfc Sigmarp Stb Tb In 4 10 0Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1150%
Pfc Sigmarp Stb Tb In 5 10 0Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1100%
Pfc Sigma/Ov Dome Pat 3 Peg 32Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer1000%
Srom Stm St 36+6l Nk 11x16x150Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented910%
Srom Stm Std 36+12l 15x20Prosthesis, hip, semi-constrained, metal/polymer, cemented900%
Delta Cer Head 12/14 32mm +5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6120.2%
Delta Cer Head 12/14 36mm +8 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented6220%
Dlt Ts Cer Hd 12/14 36mm +5 0Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented670.3%
Delta Cer Head 12/14 28mm +1 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5130%
Dlt Ts Cer Hd 12/14 36mm +1 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented520%
Attune Fb Tib Base Sz 5 CemProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer3180%
Dlt Ts Cer Hd 12/14 40mm +1 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented3180%

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
NJLProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing51734.4%
JWHProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer38425.5%
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented20513.6%
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented1308.6%
LPHProsthesis, hip, semi-constrained, metal/polymer, porous uncemented1187.8%
KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)473.1%
MRAProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented372.5%
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented221.5%
KXAProsthesis, hip, femoral, resurfacing120.8%
JDGProsthesis, hip, femoral component, cemented, metal80.5%

Reports by month, five years

011Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 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

Death0.1%1
Injury99.7%1,501
Malfunction0.2%3
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 9616671 Depuy Ireland reports

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

1,505 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Mbt Cem Keel Tib Tray Sz3 (63), Mbt Cem Keel Tib Tray Sz2 5 (43), Delta Cer Head 12/14 36mm +1 5 (41), Mbt Cem Keel Tib Tray Sz4 (37) and Delta Cer Head 12/14 36mm +5 (32).

Which device types does it report on?

prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing (34.4%), prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (25.5%), prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (13.6%) and prosthesis, hip, semi-constrained, metal/polymer, cemented (8.6%).

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.