Bone cement, antibiotic: medical device reports filed with FDA

3,709 reports carry this product code, 1992–2026; 12 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

3,709
reports with this product code: 0% of all MAUDE reports; 182
reports, 12 months to August 2026: 189 in the 12 months before; 47.6%
classified as malfunction: 62.3% across all reports; 1.3%
classified as death, as reported: 0.9% across all reports

Product code MBB is FDA's classification for "Bone cement, antibiotic" (orthopedic panel), a class 2 device. 3,709 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

182 reports arrived in the 12 months to August 2026, close to the 189 of 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 (51.1%), malfunction (47.6%) and death (1.3%). 12 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Smartset Gmv 40g Us Eo	752	40	0%	6.2%
Smartset Ghv Gentamicin 40g	576	40	0.4%	17.3%
Refobacin Bone Cement R 1x40g	242	0	1.2%	95.9%
Depuy/Cmw 2g	140	4	0.6%	4.3%
Depuy1 Gentamicin Cement 40g	135	0	0.7%	1.9%
Smartset Hv Bone Cement 40g	12	3	0%	8.1%
Simplex P-Japanese Twin Pack	4	1	10.6%	71.5%
Smartset Mv 40g - Eo	4	4	0.1%	6.2%
Unknown Bone Cement	4	37	0%	3.8%
Smartset Mv Endurance 80g	2	1	0%	0.6%
Mbt Cem Keel Tib Tray Sz3	1	9	0%	0.6%
Mbt Cem Keel Tib Tray Sz5	1	3	0%	1.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Biomet France R L	1,563	42.1%
Depuy Cmw - 9610921	767	20.7%
Depuy Cmw	94	2.5%
Depuy Cmw 9610921	51	1.4%
Zimmer Surgical	29	0.8%
Depuy Orthopaedics US 1818910	7	0.2%
Depuy Orthopaedics 1818910	4	0.1%
Depuy Orthopaedics	2	0.1%
Biomet	1	0%
Depuy France	1	0%
Depuy Ireland	1	0%
Howmedica Osteonics	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1.3%49

Injury51.1%1,895

Malfunction47.6%1,764

Other0%1

Not given0%0

Who filed

Manufacturer report98.7%3,661

Voluntary report1.1%39

User facility report0%0

Distributor report0%0

Not given0.2%9

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Loss of or failure to bond	1,103	29.7%
Unsealed device packaging	713	19.2%
Infusion or flow problema problem with flow or infusion	339	9.1%
Chemical problem	216	5.8%
Improper chemical reaction	149	4%
Insufficient device problem information	105	2.8%
Loosening of implant not related to bone-ingrowth	101	2.7%
Tear, rip or hole in device packaging	63	1.7%
Device damaged prior to usethe device was damaged before use	55	1.5%
Device contaminated during manufacture or shipping	54	1.5%
No flow	53	1.4%
Patient device interaction problem	46	1.2%
Migrationthe device moved from where it was placed	32	0.9%
Device damaged prior to receipt by user	30	0.8%
Difficult to open or remove packaging material	25	0.7%
Loss of osseointegration	24	0.6%
Device packaging compromised	21	0.6%
Device dislodged or dislocated	17	0.5%
Device operates differently than expectedthe device behaved unexpectedly	12	0.3%
Material integrity problema problem with the device material	12	0.3%

Questions about bone cement, antibiotic reports

What is product code MBB?

FDA's classification code for "Bone cement, antibiotic", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

3,709 reports through August 2026, 182 of them in the latest 12 months.

Which brands appear most often?

Smartset Gmv 40g Us Eo (752), Smartset Ghv Gentamicin 40g (576), Refobacin Bone Cement R 1x40g (242), Depuy/Cmw 2g (140) and Depuy1 Gentamicin Cement 40g (135). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.