Device brand name · Implant
Simplex P-Japanese Twin Pack: medical device reports filed with FDA
312 reports name it, 2006–2025. Manufacturer given most often on reports: Stryker Orthopaedics-Mahwah. Product code LOD.
- 312
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 1
- reports, 12 months to August 2026
- 9 in the 12 months before
- 71.5%
- classified as malfunction
- 22.1% across the product code
- 10.6%
- classified as death, as reported
- 33 reports · not verified by FDA
FDA's MAUDE database holds 312 reports that name the brand "Simplex P-Japanese Twin Pack" (implant), received between April 2006 and December 2025; the manufacturer given most often on reports is Stryker Orthopaedics-Mahwah. Spellings of one product vary from report to report.
1 reports arrived in the 12 months to August 2026, down 89% from 9 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 (71.5%), injury (17.9%) and death (10.6%); 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 (23.7%), insufficient device problem information (11.5%) and break (9%). The patient problems coded most often are death, low blood pressure/ hypotension and cardiac arrest. 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 | 74 | 23.7% | 2.2% |
| Insufficient device problem information | 36 | 11.5% | 5% |
| Breakthe device broke | 28 | 9% | 2.2% |
| Device difficult to setup or prepare | 22 | 7.1% | 0.8% |
| Device contamination with chemical or other material | 21 | 6.7% | 0.4% |
| Hole in material | 11 | 3.5% | 0.1% |
| Leak/splashthe device leaked | 11 | 3.5% | 0.6% |
| Fracturea broken bone | 7 | 2.2% | 0.7% |
| Tear, rip or hole in device packaging | 6 | 1.9% | 0.8% |
| Material integrity problema problem with the device material | 5 | 1.6% | 0.2% |
| Component falling | 4 | 1.3% | 0% |
| Detachment of device component | 4 | 1.3% | 0% |
| Device packaging compromised | 4 | 1.3% | 0.5% |
| Fluid/blood leak | 4 | 1.3% | 0.4% |
| Other (for use when an appropriate device code cannot be identified) | 4 | 1.3% | 0.7% |
| Patient device interaction problem | 4 | 1.3% | 0.7% |
| Unsealed device packaging | 4 | 1.3% | 1.5% |
| Crackthe device cracked | 3 | 1% | 0.1% |
| Device damaged prior to usethe device was damaged before use | 3 | 1% | 1.2% |
| Difficult to insertthe device was hard to insert | 3 | 1% | 0.1% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 17 | 5.4% |
| Low blood pressure/ hypotension | 16 | 5.1% |
| Cardiac arrestthe heart stopped | 14 | 4.5% |
| No patient involvement | 9 | 2.9% |
| Bone fracture(s) | 7 | 2.2% |
| Injurya physical injury | 5 | 1.6% |
| Burn(s)a burn | 3 | 1% |
| Pulmonary embolisma blood clot in the lung | 2 | 0.6% |
| Reactiona reaction, type not specified | 2 | 0.6% |
| Therapy/non-surgical treatment, additional | 2 | 0.6% |
| Abdominal painstomach or belly pain | 1 | 0.3% |
| Allergic reactionan allergic reaction | 1 | 0.3% |
| Anaphylactic shocka severe allergic reaction with collapse | 1 | 0.3% |
| Bacterial infectiona bacterial infection | 1 | 0.3% |
| Blood loss | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Simplex P-Japanese Twin Pack | Product code LOD | All MAUDE reports |
|---|---|---|---|
| Reports | 312 | 13,179 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 106 | 36 | 9 |
| Classified as injury | 17.9% | 73.8% | 36.2% |
| Classified as malfunction | 71.5% | 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% |
| Unknown Depuy Bone Cement | 285 | 0 | 0% |
| Depuy Cmw 3 40g | 228 | 0 | 1.8% |
| Smartset Mv Endurance 80g | 177 | 1 | 0% |
| Simplex P Full Dose 1 Pack | 165 | 1 | 3% |
| 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-Japanese Twin Pack reports
How many FDA reports name Simplex P-Japanese Twin Pack?
312 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 (71.5%), injury (17.9%) and death (10.6%). "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 (23.7%), insufficient device problem information (11.5%), break (9%), device difficult to setup or prepare (7.1%) and device contamination with chemical or other material (6.7%). 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-Japanese Twin 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.