Device brand name · Implant
Simplex P Full Dose 1 Pack: medical device reports filed with FDA
165 reports name it, 2008–2025. Manufacturer given most often on reports: Stryker Orthopaedics-Mahwah. Product code LOD.
- 165
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 1
- reports, 12 months to August 2026
- 5 in the 12 months before
- 56.4%
- classified as malfunction
- 22.1% across the product code
- 3%
- classified as death, as reported
- 5 reports · not verified by FDA
165 medical device reports received by FDA name the brand "Simplex P Full Dose 1 Pack" (implant); the manufacturer given most often on reports is Stryker Orthopaedics-Mahwah; received from September 2008 to September 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
1 reports arrived in the 12 months to August 2026, down 80% from 5 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 malfunction (56.4%), injury (38.8%) and death (3%); across all bone cement reports (product code LOD) death is recorded in 3.6% and malfunction in 22.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operates differently than expected (12.7%), insufficient device problem information (10.9%) and break (9.1%). The patient problems coded most often are no patient involvement, pain and bone fracture(s). 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 13,179 reports carrying product code LOD. 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 |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 21 | 12.7% | 2.2% |
| Insufficient device problem information | 18 | 10.9% | 5% |
| Breakthe device broke | 15 | 9.1% | 2.2% |
| Leak/splashthe device leaked | 7 | 4.2% | 0.6% |
| Material integrity problema problem with the device material | 6 | 3.6% | 0.2% |
| Packaging problem | 5 | 3% | 0.7% |
| Device emits odor | 4 | 2.4% | 0.5% |
| Device packaging compromised | 4 | 2.4% | 0.5% |
| Improper chemical reaction | 4 | 2.4% | 0.3% |
| Device difficult to setup or prepare | 3 | 1.8% | 0.8% |
| Fracturea broken bone | 3 | 1.8% | 0.7% |
| Clumping in device or device ingredient | 2 | 1.2% | 0.1% |
| Device contamination with chemical or other material | 2 | 1.2% | 0.4% |
| Malposition of device | 2 | 1.2% | 0.1% |
| Melted | 2 | 1.2% | 0% |
| Chemical problem | 1 | 0.6% | 2% |
| Component falling | 1 | 0.6% | 0% |
| Contamination of device ingredient or reagent | 1 | 0.6% | 0.1% |
| Crackthe device cracked | 1 | 0.6% | 0.1% |
| Defective devicethe device was defective | 1 | 0.6% | 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 |
|---|---|---|
| No patient involvement | 7 | 4.2% |
| Painpain, site not specified | 6 | 3.6% |
| Bone fracture(s) | 3 | 1.8% |
| Ambulation or postural difficulties | 2 | 1.2% |
| Cardiac arrestthe heart stopped | 2 | 1.2% |
| Deaththe patient died; cause not stated by this term | 2 | 1.2% |
| Deformity/ disfigurement | 1 | 0.6% |
| Inadequate osseointegration | 1 | 0.6% |
| Injurya physical injury | 1 | 0.6% |
| Respiratory failurethe lungs could not supply enough oxygen | 1 | 0.6% |
| Swellingswelling | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Simplex P Full Dose 1 Pack | Product code LOD | All MAUDE reports |
|---|---|---|---|
| Reports | 165 | 13,179 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 30 | 36 | 9 |
| Classified as injury | 38.8% | 73.8% | 36.2% |
| Classified as malfunction | 56.4% | 22.1% | 62.3% |
| Filed by the manufacturer | 100% | 94.9% | 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."
Other brands with product code LOD
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Smartset Gmv 40g Us Eo | 2,033 | 40 | 0% |
| Smartset Hv Bone Cement 40g | 1,124 | 3 | 0% |
| Smartset Mv 40g - Eo | 1,098 | 4 | 0.1% |
| Smartset Ghv Gentamicin 40g | 1,580 | 40 | 0.4% |
| Unknown Bone Cement | 952 | 37 | 0% |
| Unknown Depuy Cement | 394 | 0 | 0.3% |
| Depuy Cmw 2 20g | 351 | 15 | 0% |
| Depuy Cmw 1 40g | 298 | 0 | 1.3% |
| Simplex P-Japanese Twin Pack | 312 | 1 | 10.6% |
| Unknown Depuy Bone Cement | 285 | 0 | 0% |
| Depuy Cmw 3 40g | 228 | 0 | 1.8% |
| Smartset Mv Endurance 80g | 177 | 1 | 0% |
| Depuy1 Gentamicin Cement 40g | 269 | 0 | 0.7% |
| Depuy/Cmw 2g | 163 | 4 | 0.6% |
| Zimmer | 1,159 | 0 | 2.8% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Simplex P Full Dose 1 Pack reports
How many FDA reports name Simplex P Full Dose 1 Pack?
165 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.
What kinds of events are reported?
malfunction (56.4%), injury (38.8%) and death (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (12.7%), insufficient device problem information (10.9%), break (9.1%), leak/splash (4.2%) and material integrity problem (3.6%). 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 Simplex P Full Dose 1 Pack 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.