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
| Brand | Device type | Reports | Latest 12 months | Classified as death |
|---|---|---|---|---|
| Mbt Cem Keel Tib Tray Sz3 | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | 63 | 9 | 0% |
| Mbt Cem Keel Tib Tray Sz2 5 | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | 43 | 6 | 0% |
| Delta Cer Head 12/14 36mm +1 5 | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 41 | 59 | 0% |
| Mbt Cem Keel Tib Tray Sz4 | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | 37 | 4 | 0% |
| Delta Cer Head 12/14 36mm +5 | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 32 | 47 | 0% |
| Sig Mod Tib Tray Cem Cocr 3 | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | 30 | 3 | 0% |
| Pfc Sigma/Ov/Dome Pat 3peg 38 | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | 28 | 3 | 0.4% |
| Delta Cer Head 12/14 32mm +1 | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 27 | 39 | 0% |
| Mbt Cem Keel Tib Tray Sz2 | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | 25 | 3 | 0% |
| Srom Stm St 36+8l Nk 18x13x160 | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 23 | 1 | 0% |
| Pfc Sigma/Ov/Dome Pat 3peg 35 | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | 19 | 0 | 0.2% |
| Sig Mod Tib Tray Cem Cocr 2 5 | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | 18 | 2 | 0.2% |
| Sig Mod Tib Tray Cem Cocr 4 | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | 18 | 2 | 0.3% |
| Pfc Sigma/Ov/Dome Pat 3peg 41 | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | 17 | 4 | 0% |
| Mbt Cem Keel Tib Tray Sz5 | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | 15 | 3 | 0% |
| Pfc Sigmarp Stb Tb In 4 12 5 | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | 12 | 0 | 0% |
| Dlt Ts Cer Hd 12/14 36mm +8 5 | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 11 | 9 | 0.5% |
| Pfc Sigmarp Stb Tb In 3 10 0 | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | 11 | 2 | 0% |
| Pfc Sigmarp Stb Tb In 4 10 0 | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | 11 | 5 | 0% |
| Pfc Sigmarp Stb Tb In 5 10 0 | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | 11 | 0 | 0% |
| Pfc Sigma/Ov Dome Pat 3 Peg 32 | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | 10 | 0 | 0% |
| Srom Stm St 36+6l Nk 11x16x150 | Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented | 9 | 1 | 0% |
| Srom Stm Std 36+12l 15x20 | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 9 | 0 | 0% |
| Delta Cer Head 12/14 32mm +5 | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 6 | 12 | 0.2% |
| Delta Cer Head 12/14 36mm +8 5 | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 6 | 22 | 0% |
| Dlt Ts Cer Hd 12/14 36mm +5 0 | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 6 | 7 | 0.3% |
| Delta Cer Head 12/14 28mm +1 5 | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 5 | 13 | 0% |
| Dlt Ts Cer Hd 12/14 36mm +1 5 | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 5 | 2 | 0% |
| Attune Fb Tib Base Sz 5 Cem | Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer | 3 | 18 | 0% |
| Dlt Ts Cer Hd 12/14 40mm +1 5 | Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented | 3 | 18 | 0% |
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
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
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.