Prosthesis, hip, semi-constrained, metal/polymer, cemented: medical device reports filed with FDA

70,618 reports carry this product code, 1993–2026; 30 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.

70,618
reports with this product code: 0.3% of all MAUDE reports; 1,688
reports, 12 months to August 2026: 1,697 in the 12 months before; 7.8%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

Product code JDI is FDA's classification for "Prosthesis, hip, semi-constrained, metal/polymer, cemented" (orthopedic panel), a class 2 device. 70,618 medical device reports carry this product code, 0.3% of the MAUDE database, from July 1993 to August 2026.

1,688 reports arrived in the 12 months to August 2026, close to the 1,697 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 (91.3%), malfunction (7.8%) and other (0.4%). 30 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
Articuleze M Head 36mm +1 5	3,229	24	0.1%	3.9%
Articuleze M Head 36mm +5	2,902	24	0.1%	3.6%
Unknown Hip Femoral Head	1,728	176	0.7%	2%
Articuleze M Head 36mm -2	1,547	10	0.2%	3.1%
Articuleze M Head 36mm +8 5	1,544	11	0.1%	3.8%
Unknown Hip Femoral Stem	1,141	79	0.8%	6.6%
Unknown Hip	884	5	1.9%	0.8%
Unknown Head	826	103	0.7%	0.5%
Unknown Stem	798	84	0.5%	1.6%
Unknown liner	752	75	0.4%	1.7%
Unknown Reconstructive Product	711	0	0.4%	5.8%
Articul/Eze Ball 32 +1 Gr	689	5	0.1%	1.3%
UNK Hip Femoral Head Metal	668	67	0.1%	0.7%
Articul/Eze Ball 28 +1 5 Gr	637	20	0.3%	0.9%
S-Rom M Head 36mm +0	627	0	0%	5%
Unknown Cup	626	66	0.4%	3.2%
Articuleze M Head 36mm +12	605	2	0%	3.3%
Articul/Eze Ball 32 +5 Br	575	7	0%	0.3%
Articul/Eze Ball 28 +5 Br	571	14	0.2%	0.9%
12/14 Articul 40mm M Spec+1 5	551	9	0.2%	2.6%
Srom Stm St 36+8l Nk 18x13x160	551	1	0%	1.7%
V40 Cocr Lfit Head 36mm/+5	520	0	0.2%	2.1%
S-Rom M Head 36mm +3	480	0	0%	4.6%
12/14 Articul 40mm M Spec+5	473	0	0%	3.3%
Unknown Hip Implant	450	9	0.6%	3.4%
UNK Hip Acetabular Cup Pinnacle	388	67	1.2%	8.4%
Articul/Eze Ball 28 +8 5 Bl	379	13	0.3%	1.8%
Unknown Depuy Liner	343	0	0%	0.1%
S-Rom M Head 36mm +6	337	0	0%	4.5%
Unknown Zimmer Hip	329	0	0.2%	6.4%

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 Orthopaedics US	13,161	18.6%
Zimmer Biomet	7,017	9.9%
Stryker Orthopaedics-Mahwah	6,551	9.3%
Depuy Orthopaedics 1818910	5,757	8.2%
Depuy Orthopaedics	5,128	7.3%
Biomet Orthopedics	3,802	5.4%
Zimmer	2,739	3.9%
Depuy International	2,518	3.6%
Exactech	2,296	3.3%
Depuy International 8010379	1,942	2.8%
Depuy International - 8010379	1,901	2.7%
Smith & Nephew	1,740	2.5%
Stryker Orthopaedics Mahwah	1,181	1.7%
Depuy Warsaw	955	1.4%
Medacta International	741	1%

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

Death0.4%257

Injury91.3%64,443

Malfunction7.8%5,481

Other0.4%302

Not given0.2%135

Who filed

Manufacturer report98.4%69,483

Voluntary report0.9%639

User facility report0%0

Distributor report0.1%65

Not given0.6%431

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	21,697	30.7%
Device dislodged or dislocated	10,360	14.7%
Naturally worn	8,240	11.7%
Explanted	2,852	4%
Implant, removal of	2,702	3.8%
Fracturea broken bone	2,641	3.7%
Metal shedding debris	2,437	3.5%
Corrodedthe device corroded	2,046	2.9%
Breakthe device broke	1,925	2.7%
Noise, audible	1,675	2.4%
Dislocated	1,530	2.2%
Loss of osseointegration	1,515	2.1%
Material disintegration	1,395	2%
Replace	1,149	1.6%
Loose	1,004	1.4%
Degraded	998	1.4%
Loss of or failure to bond	869	1.2%
Device operates differently than expectedthe device behaved unexpectedly	815	1.2%
Material erosion	785	1.1%
Unstable	775	1.1%

Questions about prosthesis, hip, semi-constrained, metal/polymer, cemented reports

What is product code JDI?

FDA's classification code for "Prosthesis, hip, semi-constrained, metal/polymer, cemented", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

70,618 reports through August 2026, 1,688 of them in the latest 12 months.

Which brands appear most often?

Articuleze M Head 36mm +1 5 (3,229), Articuleze M Head 36mm +5 (2,902), Unknown Hip Femoral Head (1,728), Articuleze M Head 36mm -2 (1,547) and Articuleze M Head 36mm +8 5 (1,544). 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.