Devices › Prosthesis, metatarsophalangeal joint cartilage replacement implant
Device brand name · Prosthesis metatarsophalangeal joint cartilage replacement implant
Unknown Cartiva implant: medical device reports filed with FDA
241 reports name it, 2023–2026. Manufacturer given most often on reports: Cartiva. Product code PNW.
- 241
- device reports naming the brand
- 0% of all MAUDE reports · about 71 a year
- 26
- reports, 12 months to August 2026
- 201 in the 12 months before
- 0%
- classified as malfunction
- 3.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
241 medical device reports received by FDA name the brand "Unknown Cartiva implant" (prosthesis metatarsophalangeal joint cartilage replacement implant); the manufacturer given most often on reports is Cartiva; received from February 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
26 reports arrived in the 12 months to August 2026, down 87% from 201 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 (100%); across all prosthesis, metatarsophalangeal joint cartilage replacement implant reports (product code PNW) death is recorded in 0% and malfunction in 3.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unintended movement (12.9%), osseointegration problem (4.6%) and insufficient device problem information (3.7%). The patient problems coded most often are pain, implant pain and failure of implant. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 583 reports carrying product code PNW. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Unintended movement | 31 | 12.9% | 2.4% |
| Osseointegration problem | 11 | 4.6% | 5.5% |
| Insufficient device problem information | 9 | 3.7% | 9.6% |
| Implant subsidence | 6 | 2.5% | 5% |
| Migrationthe device moved from where it was placed | 5 | 2.1% | 6.9% |
| Loosening of implant not related to bone-ingrowth | 4 | 1.7% | 1.5% |
| Degraded | 3 | 1.2% | 2.2% |
| Device dislodged or dislocated | 2 | 0.8% | 0.7% |
| Material fragmentation | 2 | 0.8% | 1.7% |
| Breakthe device broke | 1 | 0.4% | 0.9% |
| Collapse | 1 | 0.4% | 0.7% |
| Fracturea broken bone | 1 | 0.4% | 0.7% |
| Material too soft/flexible | 1 | 0.4% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 63 | 26.1% |
| Implant pain | 46 | 19.1% |
| Failure of implant | 38 | 15.8% |
| Loss of range of motion | 31 | 12.9% |
| Arthritis | 15 | 6.2% |
| Discomfortdiscomfort | 15 | 6.2% |
| Inadequate osseointegration | 12 | 5% |
| Ambulation or postural difficulties | 7 | 2.9% |
| Nerve damage | 3 | 1.2% |
| Deformity/ disfigurement | 2 | 0.8% |
| Joint dislocationa dislocated joint | 2 | 0.8% |
| Bone fracture(s) | 1 | 0.4% |
| Capsular contracturescar tissue tightening around an implant | 1 | 0.4% |
| Cyst(s) | 1 | 0.4% |
| Extraskeletal ossification | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Cartiva implant | Product code PNW | All MAUDE reports |
|---|---|---|---|
| Reports | 241 | 583 | 26,136,888 |
| Share of that pool | — | 41.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 100% | 96.6% | 36.2% |
| Classified as malfunction | 0% | 3.4% | 62.3% |
| Filed by the manufacturer | 100% | 94.7% | 94.9% |
Shares are of reports, not 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."
Questions about Unknown Cartiva implant reports
How many FDA reports name Unknown Cartiva implant?
241 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 26 in the latest 12 months.
What kinds of events are reported?
injury (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unintended movement (12.9%), osseointegration problem (4.6%), insufficient device problem information (3.7%), implant subsidence (2.5%) and migration (2.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Unknown Cartiva implant was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.