Devices › Device types
FDA product code HRY · class 2 · Orthopedic
Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer: medical device reports filed with FDA
9,680 reports carry this product code, 1991–2026; 30 brands with a page.
- 9,680
- reports with this product code
- 0% of all MAUDE reports
- 332
- reports, 12 months to August 2026
- 316 in the 12 months before
- 33.2%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code HRY is FDA's classification for "Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer" (orthopedic panel), a class 2 device. 9,680 medical device reports carry this product code, 0% of the MAUDE database, from December 1991 to August 2026.
332 reports arrived in the 12 months to August 2026, close to the 316 of 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 (65.5%), malfunction (33.2%) and other (1.1%). 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 |
|---|---|---|
| Smith & Nephew | 3,167 | 32.7% |
| Depuy Orthopaedics | 1,169 | 12.1% |
| Microport Orthopedics | 907 | 9.4% |
| Biomet UK | 499 | 5.2% |
| Wright Medical Technology | 216 | 2.2% |
| Aesculap | 187 | 1.9% |
| Depuy International | 156 | 1.6% |
| 1818910 Depuy Orthopaedics | 134 | 1.4% |
| Zimmer | 119 | 1.2% |
| Depuy-Cork A Division Of Depuy Orthopaedics | 116 | 1.2% |
| Depuy Orthopaedics 1818910 | 101 | 1% |
| Depuy-Raynham A Division Of Depuy Orthopaedics | 88 | 0.9% |
| Encore Medical L P | 78 | 0.8% |
| 1219655 Depuy-Raynham A Div Of Depuy Orthopaedic | 55 | 0.6% |
| Depuy Ireland | 49 | 0.5% |
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 |
|---|---|---|
| Breakthe device broke | 1,712 | 17.7% |
| Insufficient device problem information | 1,215 | 12.6% |
| Explanted | 1,131 | 11.7% |
| Implant, removal of | 969 | 10% |
| Fracturea broken bone | 935 | 9.7% |
| Naturally worn | 908 | 9.4% |
| Component(s), worn | 604 | 6.2% |
| Loose | 443 | 4.6% |
| Replace | 408 | 4.2% |
| Loose or intermittent connection | 267 | 2.8% |
| Unstable | 249 | 2.6% |
| Detachment of device or device componentpart of the device came off | 246 | 2.5% |
| Loosening of implant not related to bone-ingrowth | 224 | 2.3% |
| Device dislodged or dislocated | 212 | 2.2% |
| Loss of or failure to bond | 169 | 1.7% |
| Crackthe device cracked | 158 | 1.6% |
| Loss of osseointegration | 101 | 1% |
| Dislocated | 99 | 1% |
| Other (for use when an appropriate device code cannot be identified) | 80 | 0.8% |
| Material deformation | 78 | 0.8% |
Questions about prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer reports
What is product code HRY?
FDA's classification code for "Prosthesis, knee, femorotibial, semi-constrained, cemented, metal/polymer", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.
How many reports carry this code?
9,680 reports through August 2026, 332 of them in the latest 12 months.
Which brands appear most often?
R3 Offset Impactor Tip (339), Journey Dcf Ap Fem Cut Blk 5 (146), Journey Dcf Ap Fem Cut Blk 6 (145), Femoral Head Impactor (143) and Unknown Oxford Bearing (88). 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.