Prosthesis, knee, hemi-, patellar resurfacing, uncemented: medical device reports filed with FDA

2,066 reports carry this product code, 1992–2018; 19 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.

2,066
reports with this product code: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 4.9%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code HTG is FDA's classification for "Prosthesis, knee, hemi-, patellar resurfacing, uncemented" (orthopedic panel), a class 2 device. 2,066 medical device reports carry this product code, 0% of the MAUDE database, from March 1992 to October 2018.

0 reports arrived in the 12 months to August 2026, and none 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 (91.3%), malfunction (4.9%) and other (2.4%). 19 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
Unknown Depuy Patella	296	0	0%	0%
Zimmer	136	0	2.8%	17.2%
Pca Knee	17	0	0%	3%
Optetrak	5	15	0%	3.5%
Pfc Sigma/Ov/Dome Pat 3peg 41	5	4	0%	1%
Biomet	4	0	0.3%	20.5%
Foundation Knee System	4	0	0%	3.8%
Pfc Sigma/Ov/Dome Pat 3peg 35	4	0	0.2%	2%
Pfc Sigma/Ov/Dome Pat 3peg 38	4	3	0.4%	1.9%
Collect No Qas Knee Implants Vega	3	0	0%	12.3%
Depuy	3	9	1.8%	27.9%
Journey	3	0	0%	13.3%
Pca	3	772	0%	0.1%
Triathlon Asymmetric X3 Patella	3	6	0%	4.1%
Unknown Patella	3	13	1.1%	0%
Foundation Knee	2	0	0%	2.7%
Pfc Sigma/Ov Dome Pat 3 Peg 32	2	0	0%	2.6%
3d Knee	1	0	0%	1.9%
Ni	1	1,587	1.8%	29.5%

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
Howmedica	430	20.8%
Zimmer	279	13.5%
Depuy Orthopaedics	178	8.6%
Biomet	75	3.6%
Sulzer Orthopedics	30	1.5%
Wright Medical Technology	22	1.1%
Exactech	16	0.8%
Zimmer Tmt	14	0.7%
Howmedica Osteonics	13	0.6%
Depuy-Cork A Division Of Depuy Orthopaedics	8	0.4%
Zimmer Manufacturing	8	0.4%
Depuy International	7	0.3%
Stryker Orthopaedics Cork	6	0.3%
Stryker Orthopaedics Limerick	4	0.2%
Biomet Orthopedics	3	0.1%

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

Death0.1%2

Injury91.3%1,886

Malfunction4.9%102

Other2.4%49

Not given1.3%27

Who filed

Manufacturer report66.9%1,383

Voluntary report2.6%53

User facility report0%0

Distributor report22.3%461

Not given8.2%169

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

Device problems coded

Device problem (FDA code)	Reports	Share
Explanted	499	24.2%
Implant, removal of	395	19.1%
Component(s), worn	341	16.5%
Replace	241	11.7%
Loose	198	9.6%
Insufficient device problem information	133	6.4%
Naturally worn	116	5.6%
Breakthe device broke	103	5%
Fracturea broken bone	78	3.8%
Other (for use when an appropriate device code cannot be identified)	53	2.6%
Material separation	51	2.5%
Component(s), broken	49	2.4%
Device issuea problem with the device	42	2%
Detachment of device component	34	1.6%
Loss of or failure to bond	33	1.6%
Device slipped	32	1.5%
Loose or intermittent connection	28	1.4%
Disassembly	23	1.1%
Fitting problem	16	0.8%
Material disintegration	16	0.8%

Questions about prosthesis, knee, hemi-, patellar resurfacing, uncemented reports

What is product code HTG?

FDA's classification code for "Prosthesis, knee, hemi-, patellar resurfacing, uncemented", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,066 reports through August 2026, 0 of them in the latest 12 months.

Which brands appear most often?

Unknown Depuy Patella (296), Zimmer (136), Pca Knee (17), Optetrak (5) and Pfc Sigma/Ov/Dome Pat 3peg 41 (5). 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.