Bone cement: medical device reports filed with FDA

13,179 reports carry this product code, 1992–2026; 26 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.

13,179
reports with this product code: 0.1% of all MAUDE reports; 310
reports, 12 months to August 2026: 399 in the 12 months before; 22.1%
classified as malfunction: 62.3% across all reports; 3.6%
classified as death, as reported: 0.9% across all reports

Product code LOD is FDA's classification for "Bone cement" (orthopedic panel), a class 2 device. 13,179 medical device reports carry this product code, 0.1% of the MAUDE database, from March 1992 to August 2026.

310 reports arrived in the 12 months to August 2026, down 22% from 399 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 (73.8%), malfunction (22.1%) and death (3.6%). 26 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	1,269	40	0%	6.2%
Smartset Hv Bone Cement 40g	1,108	3	0%	8.1%
Smartset Mv 40g - Eo	1,092	4	0.1%	6.2%
Smartset Ghv Gentamicin 40g	996	40	0.4%	17.3%
Unknown Bone Cement	942	37	0%	3.8%
Unknown Depuy Cement	370	0	0.3%	0%
Depuy Cmw 2 20g	350	15	0%	6.6%
Depuy Cmw 1 40g	297	0	1.3%	3%
Simplex P-Japanese Twin Pack	297	1	10.6%	71.5%
Unknown Depuy Bone Cement	278	0	0%	0%
Depuy Cmw 3 40g	228	0	1.8%	8.8%
Smartset Mv Endurance 80g	165	1	0%	0.6%
Simplex P Full Dose 1 Pack	164	1	3%	56.4%
Depuy1 Gentamicin Cement 40g	133	0	0.7%	1.9%
Depuy/Cmw 2g	21	4	0.6%	4.3%
Zimmer	6	0	2.8%	17.2%
UNK Hip Bone Screw	3	14	0%	4%
Attune Fb Tib Base Sz 6 Cem	2	10	0%	1.4%
Kyphx Hv-R Bone Cement	2	7	3.4%	65.3%
Air Dermatome Handpiece	1	0	0%	67.3%
Attune Fb Tib Base Sz 4 Cem	1	14	0%	1.5%
Attune Rp Tib Base Sz 7 Cem	1	7	0%	2.2%
Mbt Cem Keel Tib Tray Sz2 5	1	6	0%	0.3%
Pfc Sigma/Ov/Dome Pat 3peg 38	1	3	0.4%	1.9%
Sig Mod Tib Tray Cem Cocr 3	1	3	0%	0.6%
Unknown Depuy Tibial Tray	1	0	0%	0.2%

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
Depuy Cmw - 9610921	2,068	15.7%
Depuy Orthopaedics 1818910	1,473	11.2%
Depuy Cmw 9610921	1,370	10.4%
Depuy Cmw	957	7.3%
Stryker Orthopaedics-Mahwah	879	6.7%
Stryker Orthopaedics Limerick	496	3.8%
Howmedica	440	3.3%
Biomet France R L	396	3%
Depuy Orthopaedics US	306	2.3%
Depuy Ireland - 3015516266	167	1.3%
Zimmer Surgical	118	0.9%
Zimmer	66	0.5%
Depuy Orthopaedic 1818910	55	0.4%
Depuy Orthopaedics US 1818910	53	0.4%
Biomet	37	0.3%

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

Death3.6%469

Injury73.8%9,722

Malfunction22.1%2,916

Other0.3%46

Not given0.2%26

Who filed

Manufacturer report94.9%12,511

Voluntary report2.9%387

User facility report0%0

Distributor report0.2%23

Not given2%258

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

Device problems coded

Device problem (FDA code)	Reports	Share
Loss of or failure to bond	5,775	43.8%
Insufficient device problem information	662	5%
Loosening of implant not related to bone-ingrowth	448	3.4%
Loss of osseointegration	321	2.4%
Loose or intermittent connection	300	2.3%
Device operates differently than expectedthe device behaved unexpectedly	288	2.2%
Breakthe device broke	285	2.2%
Chemical problem	261	2%
Loose	223	1.7%
Migration or expulsion of device	214	1.6%
Unsealed device packaging	203	1.5%
Explanted	160	1.2%
Device damaged prior to usethe device was damaged before use	154	1.2%
Reactiona reaction, type not specified	143	1.1%
Implant, removal of	142	1.1%
Failure to adhere or bond	121	0.9%
Tear, rip or hole in device packaging	110	0.8%
Device difficult to setup or prepare	102	0.8%
Fracturea broken bone	96	0.7%
Nonstandard device	95	0.7%

Questions about bone cement reports

What is product code LOD?

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

How many reports carry this code?

13,179 reports through August 2026, 310 of them in the latest 12 months.

Which brands appear most often?

Smartset Gmv 40g Us Eo (1,269), Smartset Hv Bone Cement 40g (1,108), Smartset Mv 40g - Eo (1,092), Smartset Ghv Gentamicin 40g (996) and Unknown Bone Cement (942). 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.