Device brand name · Bone cement bone cement
Smartset Ghv Gentamicin 40g: medical device reports filed with FDA
1,580 reports name it, 2006–2026. Manufacturer given most often on reports: Depuy Cmw - 9610921. Product code LOD.
- 1,580
- device reports naming the brand
- 0% of all MAUDE reports · about 77 a year
- 40
- reports, 12 months to August 2026
- 46 in the 12 months before
- 17.3%
- classified as malfunction
- 22.1% across the product code
- 0.4%
- classified as death, as reported
- 7 reports · not verified by FDA
1,580 medical device reports received by FDA name the brand "Smartset Ghv Gentamicin 40g" (bone cement bone cement); the manufacturer given most often on reports is Depuy Cmw - 9610921; received from February 2006 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
40 reports arrived in the 12 months to August 2026, down 13% from 46 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 (82.2%), malfunction (17.3%) and death (0.4%); 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 loss of or failure to bond (64.8%), chemical problem (3.7%) and insufficient device problem information (2.5%). The patient problems coded most often are pain, adhesion(s) and edema. 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 |
|---|---|---|---|
| Loss of or failure to bond | 1,024 | 64.8% | 43.8% |
| Chemical problem | 58 | 3.7% | 2% |
| Insufficient device problem information | 39 | 2.5% | 5% |
| Tear, rip or hole in device packaging | 38 | 2.4% | 0.8% |
| Device contaminated during manufacture or shipping | 37 | 2.3% | 0.4% |
| Device damaged prior to usethe device was damaged before use | 37 | 2.3% | 1.2% |
| Loosening of implant not related to bone-ingrowth | 35 | 2.2% | 3.4% |
| Loose or intermittent connection | 31 | 2% | 2.3% |
| Loss of osseointegration | 30 | 1.9% | 2.4% |
| Difficult to open or remove packaging material | 21 | 1.3% | 0.2% |
| Device damaged prior to receipt by user | 14 | 0.9% | 0.5% |
| Failure to adhere or bond | 12 | 0.8% | 0.9% |
| Migrationthe device moved from where it was placed | 10 | 0.6% | 0.7% |
| Implant, removal of | 9 | 0.6% | 1.1% |
| Packaging problem | 7 | 0.4% | 0.7% |
| Expiration date error | 6 | 0.4% | 0.2% |
| Fracturea broken bone | 6 | 0.4% | 0.7% |
| Breakthe device broke | 5 | 0.3% | 2.2% |
| Fluid/blood leak | 5 | 0.3% | 0.4% |
| Loose | 5 | 0.3% | 1.7% |
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 | 741 | 46.9% |
| Adhesion(s) | 166 | 10.5% |
| Edemaswelling from fluid | 94 | 5.9% |
| Not applicable | 70 | 4.4% |
| Swelling/ edema | 64 | 4.1% |
| Joint laxity | 62 | 3.9% |
| Synovitis | 58 | 3.7% |
| Limited mobility of the implanted joint | 54 | 3.4% |
| Loss of range of motion | 54 | 3.4% |
| Discomfortdiscomfort | 44 | 2.8% |
| Ambulation or postural difficulties | 43 | 2.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 36 | 2.3% |
| Muscular rigidity | 35 | 2.2% |
| Joint disorder | 27 | 1.7% |
| Swellingswelling | 27 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Smartset Ghv Gentamicin 40g | Product code LOD | All MAUDE reports |
|---|---|---|---|
| Reports | 1,580 | 13,179 | 26,136,888 |
| Share of that pool | — | 12% | 0% |
| Classified as death, per 1,000 reports | 4 | 36 | 9 |
| Classified as injury | 82.2% | 73.8% | 36.2% |
| Classified as malfunction | 17.3% | 22.1% | 62.3% |
| Filed by the manufacturer | 99.9% | 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% |
| 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% |
| 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 Smartset Ghv Gentamicin 40g reports
How many FDA reports name Smartset Ghv Gentamicin 40g?
1,580 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 40 in the latest 12 months.
What kinds of events are reported?
injury (82.2%), malfunction (17.3%) and death (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
loss of or failure to bond (64.8%), chemical problem (3.7%), insufficient device problem information (2.5%), tear, rip or hole in device packaging (2.4%) and device contaminated during manufacture or shipping (2.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Smartset Ghv Gentamicin 40g 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.