Device manufacturer, as written on reports
Depuy International - 8010379: medical device reports filed with FDA
12,731 reports name it as the manufacturer of the device involved, 2008–2026.
- 12,731
- reports naming it as manufacturer
- 0.1% of all MAUDE reports
- 146
- reports, 12 months to August 2026
- 256 in the 12 months before
- 15.3%
- classified as malfunction
- 62.3% across all reports
- 0.4%
- classified as death, as reported
- 0.9% across all reports
12,731 medical device reports received by FDA give Depuy International - 8010379 as the manufacturer of the device involved, 0.1% of the MAUDE database, from November 2008 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.
146 reports arrived in the 12 months to August 2026, down 43% from 256 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 (84.4%), malfunction (15.3%) and death (0.4%). 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 |
|---|---|---|---|---|
| Angled Acet Insertr | Driver, prosthesis | 451 | 59 | 0% |
| Unknown Hip Acetabular Cup | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 429 | 106 | 0.4% |
| Unknown Hip Femoral Head | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 420 | 176 | 0.7% |
| UNK Hip Acetabular Cup ASR | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 341 | 20 | 0.3% |
| UNK Hip Femoral Head Metal ASR | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 316 | 25 | 0.3% |
| Unk Hip Femoral Sleeve Asr | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 272 | 16 | 0.4% |
| Unknown Hip Femoral Augment | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 270 | 0 | 0.4% |
| Adapter Sleeves 12/14 +2 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 259 | 5 | 0.4% |
| Taper Sleeve Adapter 12/14 +2 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 245 | 0 | 1.4% |
| Proxima Mi Calcar Reamer Small | Reamer | 214 | 9 | 0% |
| Large Mod Head Adapt 12/14 +5 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 204 | 2 | 1.7% |
| Depuy Asr Xl Fem Imp Size 45 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 166 | 1 | 0.3% |
| Articul/Eze Ball 32 +1 Gr | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 156 | 5 | 0.1% |
| Asr Acetabular Implant 52 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 155 | 3 | 0% |
| Depuy Asr Xl Fem Imp Size 47 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 151 | 4 | 0.5% |
| Adapter Sleeves 12/14 +5 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 148 | 0 | 0.5% |
| Articul/Eze Ball 28 +1 5 Gr | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 142 | 20 | 0.3% |
| Depuy Asr Xl Fem Imp Size 46 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 138 | 0 | 0.5% |
| Total Asr Acet Imp Size 50 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 124 | 0 | 0.2% |
| Asr Acetabular Implant 54 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 108 | 4 | 0.1% |
| Total Asr Acet Imp Size 54 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 108 | 0 | 0.7% |
| Articul/Eze Ball 32 +5 Br | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 106 | 7 | 0% |
| Depuy Asr Xl Fem Imp Size 49 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 105 | 0 | 0.4% |
| Asr Acetabular Implant 50 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 104 | 1 | 0% |
| Asr Uni Femoral Impl Size 49 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 101 | 0 | 0.4% |
| Sigma Hp Fem Notch Impactor | Impactor | 98 | 8 | 0% |
| Articul/Eze Ball 28 +5 Br | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 96 | 14 | 0.2% |
| Total Asr Acet Imp Size 56 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 96 | 0 | 0.5% |
| Asr Uni Femoral Impl Size 47 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 94 | 0 | 0.4% |
| Asr Acetabular Implant 56 | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 92 | 0 | 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
| Product code | Device type | Reports | Share |
|---|---|---|---|
| KWA | Prosthesis, hip, semi-constrained (metal uncemented acetabular component) | 6,177 | 48.5% |
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented | 1,901 | 14.9% |
| KXA | Prosthesis, hip, femoral, resurfacing | 986 | 7.7% |
| LPH | Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented | 771 | 6.1% |
| HWR | Driver, prosthesis | 594 | 4.7% |
| KWY | Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented | 520 | 4.1% |
| HTO | Reamer | 262 | 2.1% |
| HWA | Impactor | 191 | 1.5% |
| NJL | Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing | 175 | 1.4% |
| HWT | Template | 100 | 0.8% |
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 Depuy International - 8010379 reports
How many FDA device reports name Depuy International - 8010379 as manufacturer?
12,731 reports through August 2026, 146 of them in the latest 12 months.
Which of its brands appear most often?
Angled Acet Insertr (451), Unknown Hip Acetabular Cup (429), Unknown Hip Femoral Head (420), UNK Hip Acetabular Cup ASR (341) and UNK Hip Femoral Head Metal ASR (316).
Which device types does it report on?
prosthesis, hip, semi-constrained (metal uncemented acetabular component) (48.5%), prosthesis, hip, semi-constrained, metal/polymer, cemented (14.9%), prosthesis, hip, femoral, resurfacing (7.7%) and prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (6.1%).
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.