Devices › Bone cement, antibiotic
Device brand name · Bone cement antibiotic
Refobacin Bone Cement R 1x40g: medical device reports filed with FDA
242 reports name it, 2016–2021. Manufacturer given most often on reports: Biomet France R L. Product code MBB.
- 242
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 95.9%
- classified as malfunction
- 47.6% across the product code
- 1.2%
- classified as death, as reported
- 3 reports · not verified by FDA
242 medical device reports received by FDA name the brand "Refobacin Bone Cement R 1x40g" (bone cement antibiotic); the manufacturer given most often on reports is Biomet France R L; received from July 2016 to September 2021. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (95.9%), injury (2.9%) and death (1.2%); across all bone cement, antibiotic reports (product code MBB) death is recorded in 1.3% and malfunction in 47.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are unsealed device packaging (93%), insufficient device problem information (1.7%) and tear, rip or hole in device packaging (0.8%). The patient problems coded most often are no patient involvement, bradycardia and foreign body reaction. 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 3,709 reports carrying product code MBB. 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 |
|---|---|---|---|
| Unsealed device packaging | 225 | 93% | 19.2% |
| Insufficient device problem information | 4 | 1.7% | 2.8% |
| Tear, rip or hole in device packaging | 2 | 0.8% | 1.7% |
| Leak/splashthe device leaked | 1 | 0.4% | 0.3% |
| Loosening of implant not related to bone-ingrowth | 1 | 0.4% | 2.7% |
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 |
|---|---|---|
| No patient involvement | 14 | 5.8% |
| Bradycardiaslow heart rate | 2 | 0.8% |
| Foreign body reaction | 2 | 0.8% |
| Failure of implant | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Refobacin Bone Cement R 1x40g | Product code MBB | All MAUDE reports |
|---|---|---|---|
| Reports | 242 | 3,709 | 26,136,888 |
| Share of that pool | — | 6.5% | 0% |
| Classified as death, per 1,000 reports | 12 | 13 | 9 |
| Classified as injury | 2.9% | 51.1% | 36.2% |
| Classified as malfunction | 95.9% | 47.6% | 62.3% |
| Filed by the manufacturer | 100% | 98.7% | 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."
Other brands with product code MBB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Smartset Gmv 40g Us Eo | 2,033 | 40 | 0% |
| Smartset Ghv Gentamicin 40g | 1,580 | 40 | 0.4% |
| Depuy/Cmw 2g | 163 | 4 | 0.6% |
| Depuy1 Gentamicin Cement 40g | 269 | 0 | 0.7% |
| Smartset Hv Bone Cement 40g | 1,124 | 3 | 0% |
| Simplex P-Japanese Twin Pack | 312 | 1 | 10.6% |
| Smartset Mv 40g - Eo | 1,098 | 4 | 0.1% |
| Unknown Bone Cement | 952 | 37 | 0% |
| Smartset Mv Endurance 80g | 177 | 1 | 0% |
| Mbt Cem Keel Tib Tray Sz3 | 1,085 | 9 | 0% |
| Mbt Cem Keel Tib Tray Sz5 | 371 | 3 | 0% |
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 Refobacin Bone Cement R 1x40g reports
How many FDA reports name Refobacin Bone Cement R 1x40g?
242 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (95.9%), injury (2.9%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
unsealed device packaging (93%), insufficient device problem information (1.7%), tear, rip or hole in device packaging (0.8%), leak/splash (0.4%) and loosening of implant not related to bone-ingrowth (0.4%). 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 Refobacin Bone Cement R 1x40g 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.