Devices › Device types
FDA product code KWY · class 2 · Orthopedic
Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented: medical device reports filed with FDA
16,523 reports carry this product code, 1992–2026; 30 brands with a page.
- 16,523
- reports with this product code
- 0.1% of all MAUDE reports
- 217
- reports, 12 months to August 2026
- 163 in the 12 months before
- 7.4%
- classified as malfunction
- 62.3% across all reports
- 0.3%
- classified as death, as reported
- 0.9% across all reports
Product code KWY is FDA's classification for "Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented" (orthopedic panel), a class 2 device. 16,523 medical device reports carry this product code, 0.1% of the MAUDE database, from July 1992 to August 2026.
217 reports arrived in the 12 months to August 2026, up 33% from 163 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 (90.2%), malfunction (7.4%) and other (1.9%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Depuy Orthopaedics | 2,580 | 15.6% |
| Depuy Orthopaedics US | 2,053 | 12.4% |
| Depuy Orthopaedics 1818910 | 992 | 6% |
| Zimmer | 983 | 5.9% |
| Depuy International 8010379 | 662 | 4% |
| Depuy International - 8010379 | 520 | 3.1% |
| Depuy International | 507 | 3.1% |
| Depuy Warsaw | 471 | 2.9% |
| Zimmer Biomet | 375 | 2.3% |
| 1818910 Depuy Orthopaedics | 349 | 2.1% |
| Encore Medical L P | 258 | 1.6% |
| Biomet Orthopedics | 257 | 1.6% |
| Stryker Orthopaedics Cork | 248 | 1.5% |
| Stryker Orthopaedics Mahwah | 213 | 1.3% |
| Stryker Orthopaedics-Mahwah | 210 | 1.3% |
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 and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Insufficient device problem information | 3,952 | 23.9% |
| Device dislodged or dislocated | 2,476 | 15% |
| Explanted | 1,610 | 9.7% |
| Implant, removal of | 1,169 | 7.1% |
| Naturally worn | 972 | 5.9% |
| Replace | 748 | 4.5% |
| Fracturea broken bone | 727 | 4.4% |
| Loose | 659 | 4% |
| Dislocated | 617 | 3.7% |
| Breakthe device broke | 502 | 3% |
| Loss of osseointegration | 429 | 2.6% |
| Metal shedding debris | 347 | 2.1% |
| Component(s), worn | 271 | 1.6% |
| Corrodedthe device corroded | 250 | 1.5% |
| Noise, audible | 227 | 1.4% |
| Device slipped | 209 | 1.3% |
| Loss of or failure to bond | 186 | 1.1% |
| Difficult to insertthe device was hard to insert | 173 | 1% |
| Migration or expulsion of device | 155 | 0.9% |
| Loose or intermittent connection | 141 | 0.9% |
Questions about prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented reports
What is product code KWY?
FDA's classification code for "Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.
How many reports carry this code?
16,523 reports through August 2026, 217 of them in the latest 12 months.
Which brands appear most often?
Unknown Hip Femoral Head (1,237), Unknown Depuy Femoral Head (621), Unknown Hip Acetabular Liners (456), Unknown Hip Femoral Stem (355) and Unknown Depuy Stem (278). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
No. 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 differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.