Reported Reactions

Manufacturers

Device manufacturer, as written on reports

Depuy Ireland Reg 9616671: medical device reports filed with FDA

1,262 reports name it as the manufacturer of the device involved, 2011–2017.

1,262
reports naming it as manufacturer
0% of all MAUDE reports
0
reports, 12 months to August 2026
0 in the 12 months before
1.9%
classified as malfunction
62.3% across all reports
0%
classified as death, as reported
0.9% across all reports

1,262 medical device reports received by FDA give Depuy Ireland Reg 9616671 as the manufacturer of the device involved, 0% of the MAUDE database, from May 2011 to May 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 (98.1%) and malfunction (1.9%). 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
Delta Cer Head 12/14 36mm +1 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented64590%
Delta Cer Head 12/14 36mm +5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented57470%
Delta Cer Head 12/14 32mm +1Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented38390%
Delta Cer Head 12/14 32mm +5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented24120.2%
Srom Stm St 36+8l Nk 18x13x160Prosthesis, hip, semi-constrained, metal/polymer, cemented2310%
Srom Stm St 36+6l Nk 11x16x150Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented1910%
Mbt Cem Keel Tib Tray Sz3Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1690%
Dlt Ts Cer Hd 12/14 36mm +1 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1520%
Delta Cer Head 12/14 36mm +8 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented14220%
Mbt Cem Keel Tib Tray Sz2 5Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1360%
Mbt Cem Keel Tib Tray Sz4Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1240%
Delta Cer Head 12/14 32mm +9Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1160.5%
Mbt Cem Keel Tib Tray Sz2Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1130%
S-Rom Sleeve Prx Ztt 18d-LrgProsthesis, hip, semi-constrained, metal/polymer, porous uncemented1100%
Articuleze M Head 36mm +5Prosthesis, hip, semi-constrained, metal/polymer, cemented10240.1%
Delta Cer Head 12/14 28mm +1 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented10130%
Dlt Ts Cer Hd 12/14 36mm +5 0Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented1070.3%
Srom Stm Std 36+12l 13x18Prosthesis, hip, semi-constrained, metal/polymer, cemented1000.3%
Articuleze M Head 36mm +1 5Prosthesis, hip, semi-constrained, metal/polymer, cemented9240.1%
Dlt Ts Cer Hd 12/14 32mm +5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented940%
Attune Fb Tib Base Sz 4 CemProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer8140%
Pfc Sigmarp Stb Tb In 4 10 0Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing850%
Articuleze M Head 36mm -2Prosthesis, hip, semi-constrained, metal/polymer, cemented7100.2%
Dlt Ts Cer Hd 12/14 36mm +8 5Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented790.5%
Sig Mod Tib Tray Cem Cocr 3Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer730%
Mbt Cem Tibial Tray Sz3Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing600%
Articuleze M Head 36mm +15 5Prosthesis, hip, semi-constrained, metal/polymer, cemented500%
Dlt Ts Cer Hd 12/14 40mm +5 0Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented5170%
Pfc Sigma/Ov/Dome Pat 3peg 38Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer530.4%
Srom Stm St 36+8l Nk 20x15x165Prosthesis, hip, semi-constrained, metal/polymer, cemented500.9%

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
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented38130.2%
NJLProsthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing26921.3%
JWHProsthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer17213.6%
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented16613.2%
LPHProsthesis, hip, semi-constrained, metal/polymer, porous uncemented13911%
MRAProsthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented453.6%
KWAProsthesis, hip, semi-constrained (metal uncemented acetabular component)332.6%
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented252%
KXAProsthesis, hip, femoral, resurfacing90.7%
HSDProsthesis, shoulder, hemi-, humeral, metallic uncemented50.4%

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%0
Injury98.1%1,238
Malfunction1.9%24
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 Reg 9616671 reports

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

1,262 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Delta Cer Head 12/14 36mm +1 5 (64), Delta Cer Head 12/14 36mm +5 (57), Delta Cer Head 12/14 32mm +1 (38), Delta Cer Head 12/14 32mm +5 (24) and Srom Stm St 36+8l Nk 18x13x160 (23).

Which device types does it report on?

prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented (30.2%), prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing (21.3%), prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer (13.6%) and prosthesis, hip, semi-constrained, metal/polymer, cemented (13.2%).

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.