Prosthesis, knee, hemi-, femoral: medical device reports filed with FDA

2,315 reports carry this product code, 1992–2026; 28 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.

2,315
reports with this product code: 0% of all MAUDE reports; 2
reports, 12 months to August 2026: 1 in the 12 months before; 10.1%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code HSA is FDA's classification for "Prosthesis, knee, hemi-, femoral" (orthopedic panel), a class 3 device. 2,315 medical device reports carry this product code, 0% of the MAUDE database, from June 1992 to February 2026.

2 reports arrived in the 12 months to August 2026, up 100% from 1 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 (86%), malfunction (10.1%) and other (3.2%). 28 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
Profix	268	0	0%	0.1%
Unknown Depuy Femoral Component	205	0	0%	0%
Unknown Femoral Component	18	90	0.3%	1.6%
Optetrak	14	15	0%	3.5%
Journey	10	0	0%	13.3%
Unknown Depuy Femoral Stem	8	0	0.1%	5.4%
Genesis	7	0	0.1%	1.9%
Triathlon Ps Fem Component Cemented	6	6	0.3%	22.8%
Biomet	5	0	0.3%	20.5%
Foundation Knee	4	0	0%	2.7%
Foundation Knee System	4	0	0%	3.8%
Nexgen Lps-Flex Gsf Femoral Component	3	0	0%	3.4%
Zimmer	3	0	2.8%	17.2%
Synergy	2	84	3.5%	63.3%
Unknown Depuy Femoral Head	2	0	0.1%	0.6%
Unknown Depuy Stem	2	0	0.3%	1.4%
3dknee	1	0	0%	0.7%
Asr Uni Femoral Impl Size 45	1	0	0.1%	0.1%
Echelon	1	584	3.2%	72.8%
Mbt Cem Keel Tib Tray Sz2	1	3	0%	0.3%
Nexgen Cr-Flex Femoral Component	1	0	0%	5.2%
Nexgen Lps-Flex Articular Surface	1	0	0%	46.8%
Nexgen Lps-Flex Femoral Component	1	0	0%	4.8%
Optetrak Logic	1	25	0.5%	1.8%
Pca	1	772	0%	0.1%
Unk Depuy Insert	1	0	0%	0%
Unknown Oxford Femoral Component	1	30	0.3%	0%
Zimmer M/L Taper Femoral Stem	1	0	0%	25.5%

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	645	27.9%
Smith & Nephew Orthopaedic Div	473	20.4%
Zimmer	218	9.4%
Biomet	91	3.9%
Exactech	35	1.5%
Smith & Nephew	35	1.5%
Wright Medical Technology	35	1.5%
Depuy-Raynham A Division Of Depuy Orthopaedics	25	1.1%
Howmedica	20	0.9%
Stryker Orthopaedics Limerick	20	0.9%
Stryker Orthopaedics Mahwah	19	0.8%
Depuy-Raynham A Div Of Depuy Orthopaedics	17	0.7%
Encore Medical L P	13	0.6%
Biomet Orthopedics	6	0.3%
Sulzer Orthopedics	5	0.2%

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

Injury86%1,990

Malfunction10.1%233

Other3.2%75

Not given0.7%16

Who filed

Manufacturer report90.8%2,103

Voluntary report1.9%44

User facility report0%0

Distributor report1.6%36

Not given5.7%132

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

Device problems coded

Device problem (FDA code)	Reports	Share
Explanted	1,131	48.9%
Loose	733	31.7%
Implant, removal of	578	25%
Replace	392	16.9%
Component(s), worn	126	5.4%
Other (for use when an appropriate device code cannot be identified)	105	4.5%
Breakthe device broke	84	3.6%
Device remains implanted	78	3.4%
Fracturea broken bone	73	3.2%
Insufficient device problem information	70	3%
Loss of or failure to bond	45	1.9%
Loose or intermittent connection	38	1.6%
Loss of osseointegration	34	1.5%
Component(s), broken	30	1.3%
Dislocated	27	1.2%
Device slipped	26	1.1%
Device issuea problem with the device	24	1%
Tear, rip or hole in device packaging	19	0.8%
Foreign material	14	0.6%
Device, or device fragments remain in patient	12	0.5%

Questions about prosthesis, knee, hemi-, femoral reports

What is product code HSA?

FDA's classification code for "Prosthesis, knee, hemi-, femoral", class 3, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,315 reports through August 2026, 2 of them in the latest 12 months.

Which brands appear most often?

Profix (268), Unknown Depuy Femoral Component (205), Unknown Femoral Component (18), Optetrak (14) and Journey (10). 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.