Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer: medical device reports filed with FDA

2,538 reports carry this product code, 1993–2026; 13 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.

2,538
reports with this product code: 0% of all MAUDE reports; 153
reports, 12 months to August 2026: 170 in the 12 months before; 21.7%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code HSX is FDA's classification for "Prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer" (orthopedic panel), a class 2 device. 2,538 medical device reports carry this product code, 0% of the MAUDE database, from April 1993 to August 2026.

153 reports arrived in the 12 months to August 2026, down 10% from 170 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 (77.3%), malfunction (21.7%) and other (0.7%). 13 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
Iuni G2	193	0	0%	8.6%
Itotal G2	9	0	0%	7.5%
Unkn Orthopaedic Reconstruction Dev	4	17	0.4%	5%
Unknown Femoral Component	4	90	0.3%	1.6%
Unknown Articular Surface	3	78	0%	1.1%
Genesis	2	0	0.1%	1.9%
Unknown Stryker knee	2	17	0.5%	2.1%
Real Intelligence Cori	1	97	0%	80.4%
Unknown Depuy Cement	1	0	0.3%	0%
Unknown Femoral	1	27	0%	0%
Unknown Knee Implant	1	16	0%	3.3%
Unknown Persona Femoral Component	1	87	0%	0%
Unknown Reconstructive Product	1	0	0.4%	5.8%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Conformis	266	10.5%
Medacta International	186	7.3%
Blue Belt Technologies	63	2.5%
Zimmer Orthopaedic Mfg	61	2.4%
Mako Surgical	54	2.1%
Stryker Orthopaedics Limerick	34	1.3%
Tornier S	26	1%
Tornier	17	0.7%
Depuy Cmw 9610921	1	0%
Zimmer Manufacturing	1	0%
Zimmer Tmt	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

Death0%1

Injury77.3%1,963

Malfunction21.7%551

Other0.7%18

Not given0.2%5

Who filed

Manufacturer report98.9%2,510

Voluntary report0.8%20

User facility report0%0

Distributor report0.1%2

Not given0.2%6

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	349	13.8%
Fracturea broken bone	293	11.5%
Breakthe device broke	214	8.4%
Loosening of implant not related to bone-ingrowth	154	6.1%
Naturally worn	64	2.5%
Device slipped	54	2.1%
Loose or intermittent connection	52	2%
Device dislodged or dislocated	49	1.9%
Explanted	49	1.9%
Migrationthe device moved from where it was placed	41	1.6%
Unstable	37	1.5%
Device appears to trigger rejection	35	1.4%
Difficult to insertthe device was hard to insert	35	1.4%
Crackthe device cracked	27	1.1%
Migration or expulsion of device	26	1%
Malposition of device	24	0.9%
Device operates differently than expectedthe device behaved unexpectedly	23	0.9%
Fitting problem	21	0.8%
Positioning failure	21	0.8%
Loose	20	0.8%

Questions about prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer reports

What is product code HSX?

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

How many reports carry this code?

2,538 reports through August 2026, 153 of them in the latest 12 months.

Which brands appear most often?

Iuni G2 (193), Itotal G2 (9), Unkn Orthopaedic Reconstruction Dev (4), Unknown Femoral Component (4) and Unknown Articular Surface (3). 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.