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

7,103 reports carry this product code, 1994–2026; 17 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.

7,103
reports with this product code: 0% of all MAUDE reports; 1,801
reports, 12 months to August 2026: 1,425 in the 12 months before; 3.4%
classified as malfunction: 62.3% across all reports; 0%
classified as death, as reported: 0.9% across all reports

Product code HSN is FDA's classification for "Prosthesis, ankle, semi-constrained, cemented, metal/polymer" (orthopedic panel), a class 2 device. 7,103 medical device reports carry this product code, 0% of the MAUDE database, from June 1994 to August 2026.

1,801 reports arrived in the 12 months to August 2026, up 26% from 1,425 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 (96.4%), malfunction (3.4%) and other (0.1%). 17 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
Infinity Total Ankle System	401	0	0%	2.5%
Unknown Talar component	381	149	1.1%	0.2%
Unknown Total Ankle System	354	88	0%	0%
Unknown Tibial Component	345	200	0%	0.5%
Unknown Total Ankle Replacement	185	161	0%	0%
Inbone Total Ankle System	145	0	0%	6.7%
Star Total Ankle Replacement	66	0	0%	0%
Unknown Star Talar Component	62	0	0%	0%
Unknown Bearing	28	84	0.3%	2.2%
Infinity	27	24	2.1%	45.6%
Quantum	26	35	0.5%	66.7%
Unknown Tibial Tray	11	25	0.2%	3%
Unknown Depuy Tibial Insert	2	0	0%	0.1%
Dow Corning	1	0	0.7%	17.8%
Jgrknt 1 0mm Mini 3-0 Ndls	1	3	0%	75.2%
UNK Attune Knee Patella	1	23	0.4%	1.3%
Unknown Depuy Insert	1	0	0%	0%

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
Wright Medical Technology	4,827	68%
Exactech	334	4.7%
Zimmer Biomet	219	3.1%
Stryker	139	2%
Paragon 28	128	1.8%
Ascension Orthopedics	98	1.4%
Tornier S	56	0.8%
Depuy Orthopaedics	34	0.5%
Depuy Warsaw	31	0.4%
1818910 Depuy Orthopaedics	19	0.3%
Biomet UK	17	0.2%
Tornier	7	0.1%
Integra Lifesciences Oh/USA	5	0.1%
Dow Corning	1	0%
Johnson & Johnson Medical Suzhou	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%3

Injury96.4%6,846

Malfunction3.4%242

Other0.1%6

Not given0.1%6

Who filed

Manufacturer report99.1%7,038

Voluntary report0.3%21

User facility report0%0

Distributor report0.4%31

Not given0.2%13

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	1,535	21.6%
Osseointegration problem	1,196	16.8%
Migrationthe device moved from where it was placed	561	7.9%
Loss of osseointegration	350	4.9%
Naturally worn	194	2.7%
Implant, removal of	189	2.7%
Fracturea broken bone	170	2.4%
Implant subsidence	146	2.1%
Breakthe device broke	119	1.7%
Explanted	118	1.7%
Loose	110	1.5%
Loosening of implant not related to bone-ingrowth	99	1.4%
Malposition of device	80	1.1%
Migration or expulsion of device	78	1.1%
Device dislodged or dislocated	67	0.9%
Component(s), worn	63	0.9%
Loss of or failure to bond	54	0.8%
Inadequacy of device shape and/or size	52	0.7%
Unstable	50	0.7%
Loose or intermittent connection	44	0.6%

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

What is product code HSN?

FDA's classification code for "Prosthesis, ankle, semi-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?

7,103 reports through August 2026, 1,801 of them in the latest 12 months.

Which brands appear most often?

Infinity Total Ankle System (401), Unknown Talar component (381), Unknown Total Ankle System (354), Unknown Tibial Component (345) and Unknown Total Ankle Replacement (185). 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.