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FDA product code KWZ · class 2 · Orthopedic
Prosthesis, hip, constrained, cemented or uncemented, metal/polymer: medical device reports filed with FDA
5,692 reports carry this product code, 1993–2026; 30 brands with a page.
- 5,692
- reports with this product code
- 0% of all MAUDE reports
- 183
- reports, 12 months to August 2026
- 160 in the 12 months before
- 9.3%
- classified as malfunction
- 62.3% across all reports
- 0.4%
- classified as death, as reported
- 0.9% across all reports
Product code KWZ is FDA's classification for "Prosthesis, hip, constrained, cemented or uncemented, metal/polymer" (orthopedic panel), a class 2 device. 5,692 medical device reports carry this product code, 0% of the MAUDE database, from April 1993 to August 2026.
183 reports arrived in the 12 months to August 2026, up 14% from 160 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 (89.7%), malfunction (9.3%) and other (0.5%). 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 |
|---|---|---|
| Zimmer | 1,509 | 26.5% |
| Biomet Orthopedics | 202 | 3.5% |
| Stryker Orthopaedics-Mahwah | 146 | 2.6% |
| Encore Medical L P | 103 | 1.8% |
| Depuy Orthopaedics | 96 | 1.7% |
| Stryker Orthopaedics Mahwah | 73 | 1.3% |
| Depuy Orthopaedics US | 38 | 0.7% |
| 1818910 Depuy Orthopaedics | 31 | 0.5% |
| Depuy-Cork A Division Of Depuy Orthopaedics | 23 | 0.4% |
| Biomet UK | 14 | 0.2% |
| Biomet | 12 | 0.2% |
| Smith & Nephew Orthopaedic Div | 10 | 0.2% |
| Depuy International | 8 | 0.1% |
| Depuy International 8010379 | 4 | 0.1% |
| Depuy Ireland Reg 9616671 | 4 | 0.1% |
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 |
|---|---|---|
| Device dislodged or dislocated | 1,965 | 34.5% |
| Insufficient device problem information | 1,250 | 22% |
| Fracturea broken bone | 337 | 5.9% |
| Naturally worn | 246 | 4.3% |
| Explanted | 172 | 3% |
| Breakthe device broke | 157 | 2.8% |
| Failure to adhere or bond | 148 | 2.6% |
| Migration or expulsion of device | 119 | 2.1% |
| Dislocated | 118 | 2.1% |
| Implant, removal of | 113 | 2% |
| Unstable | 107 | 1.9% |
| Corrodedthe device corroded | 99 | 1.7% |
| Disassembly | 78 | 1.4% |
| Difficult to insertthe device was hard to insert | 72 | 1.3% |
| Device contaminated during manufacture or shipping | 68 | 1.2% |
| Replace | 68 | 1.2% |
| Detachment of device or device componentpart of the device came off | 66 | 1.2% |
| Device slipped | 52 | 0.9% |
| Malposition of device | 43 | 0.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 38 | 0.7% |
Questions about prosthesis, hip, constrained, cemented or uncemented, metal/polymer reports
What is product code KWZ?
FDA's classification code for "Prosthesis, hip, constrained, cemented or uncemented, 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?
5,692 reports through August 2026, 183 of them in the latest 12 months.
Which brands appear most often?
Unknown Hip Acetabular Liners (191), Pinn Lnr Con +4 Neut 28idx50od (145), Unknown Zimmer Hip (94), Fmp Hip (45) and Srom Stm St 36+8l Nk 18x13x160 (15). 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.