Prosthesis, knee, hemi-, tibial, resurfacing (uncemented): medical device reports filed with FDA

8,111 reports carry this product code, 1992–2022; 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.

8,111
reports with this product code: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 13.3%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code HSH is FDA's classification for "Prosthesis, knee, hemi-, tibial, resurfacing (uncemented)" (orthopedic panel), a class 2 device. 8,111 medical device reports carry this product code, 0% of the MAUDE database, from March 1992 to August 2022.

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 (80.6%), malfunction (13.3%) and other (5.4%). 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
Unknown Depuy Insert	293	0	0%	0%
Unknown Depuy Tibial Tray	266	0	0%	0.2%
Unknown Depuy Tibial Insert	205	0	0%	0.1%
Foundation Knee System	143	0	0%	3.8%
Zimmer	142	0	2.8%	17.2%
Unk Depuy Insert	103	0	0%	0%
Genesis	45	0	0.1%	1.9%
Series 7000 Standard Tibia	45	0	0%	7.8%
Journey	43	0	0%	13.3%
Optetrak	38	15	0%	3.5%
Biomet	34	0	0.3%	20.5%
Triathlon Cr X3 Tibial Insert	29	13	0%	8.4%
Mbt Cem Keel Tib Tray Sz3	26	9	0%	0.6%
Pca Knee	18	0	0%	3%
Triathlon Ps X3 Tibial Insert	18	21	0%	12.9%
Profix	15	0	0%	0.1%
Unknown Tibial Tray	15	25	0.2%	3%
Mbt Cem Keel Tib Tray Sz4	14	4	0%	0.2%
3dknee	12	0	0%	0.7%
Triathlon Prim Tib Baseplate - Cemented	12	3	0.5%	13.3%
Nexgen Stemmed Tibial Component	11	0	0%	12.7%
Unknown Depuy Patella	9	0	0%	0%
Mbt Cem Keel Tib Tray Sz5	8	3	0%	1.3%
Pfc Keel Tib Tray Cem Sz3	8	0	0%	0.6%
Pfc Sigmarp Stb Tb In 3 10 0	8	2	0%	0%
Mbt Cem Keel Tib Tray Sz2 5	7	6	0%	0.3%
Nexgen Mis Stemmed Tibial Component	7	0	0%	10.5%
Pfc Sigma Mod Tib Tray Cem Sz4	7	0	0%	1.1%
Unknown Tibial Component	7	200	0%	0.5%
Foundation Knee	6	0	0%	2.7%

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	1,867	23%
Howmedica	1,275	15.7%
Sulzer Orthopedics	806	9.9%
Zimmer	783	9.7%
Encore Medical L P	330	4.1%
Howmedica Osteonics	277	3.4%
Biomet	232	2.9%
Stryker Orthopaedics Mahwah	230	2.8%
Wright Medical Technology	174	2.1%
Smith & Nephew Orthopaedic Div	149	1.8%
Stryker Orthopaedics Cork	145	1.8%
Stryker Orthopaedics Limerick	141	1.7%
Exactech	132	1.6%
Conformis	76	0.9%
Depuy-Cork A Division Of Depuy Orthopaedics	55	0.7%

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%7

Injury80.6%6,536

Malfunction13.3%1,076

Other5.4%439

Not given0.7%53

Who filed

Manufacturer report89.7%7,279

Voluntary report1.3%109

User facility report0%0

Distributor report4.3%351

Not given4.6%372

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

Device problems coded

Device problem (FDA code)	Reports	Share
Explanted	3,753	46.3%
Replace	2,113	26.1%
Implant, removal of	1,487	18.3%
Loose	1,419	17.5%
Component(s), worn	1,351	16.7%
Fitting problem	340	4.2%
Breakthe device broke	289	3.6%
Insufficient device problem information	275	3.4%
Other (for use when an appropriate device code cannot be identified)	218	2.7%
Fracturea broken bone	214	2.6%
Naturally worn	204	2.5%
Device slipped	140	1.7%
Dislocated	124	1.5%
Component(s), broken	123	1.5%
Device issuea problem with the device	120	1.5%
Device remains implanted	105	1.3%
Material separation	77	0.9%
Unstable	70	0.9%
Loss of or failure to bond	51	0.6%
Difficult to insertthe device was hard to insert	50	0.6%

Questions about prosthesis, knee, hemi-, tibial, resurfacing (uncemented) reports

What is product code HSH?

FDA's classification code for "Prosthesis, knee, hemi-, tibial, 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?

8,111 reports through August 2026, 0 of them in the latest 12 months.

Which brands appear most often?

Unknown Depuy Insert (293), Unknown Depuy Tibial Tray (266), Unknown Depuy Tibial Insert (205), Foundation Knee System (143) and Zimmer (142). 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.