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

9,412 reports carry this product code, 1994–2026; 18 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.

9,412
reports with this product code: 0% of all MAUDE reports; 933
reports, 12 months to August 2026: 872 in the 12 months before; 10.5%
classified as malfunction: 62.3% across all reports; 0.6%
classified as death, as reported: 0.9% across all reports

Product code KRO is FDA's classification for "Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer" (orthopedic panel), a class 2 device. 9,412 medical device reports carry this product code, 0% of the MAUDE database, from March 1994 to August 2026.

933 reports arrived in the 12 months to August 2026, close to the 872 of 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 (88.7%), malfunction (10.5%) and death (0.6%). 18 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
Eleos	951	2	0.1%	4.9%
ELEOS Limb Salvage System	940	453	0.9%	0.9%
Unknown Femoral Component	7	90	0.3%	1.6%
Unknown Stryker knee	7	17	0.5%	2.1%
Unknown Knee	5	18	1.5%	0.3%
Unknown Articular Surface	3	78	0%	1.1%
Nexgen Stemmed Tibial Component	1	0	0%	12.7%
Pfc Sigma/Ov Dome Pat 3 Peg 32	1	0	0%	2.6%
Series 7000 Standard Tibia	1	0	0%	7.8%
Sig Mod Tib Tray Cem Cocr 4	1	2	0.3%	0.6%
Simplex P-Japanese Twin Pack	1	1	10.6%	71.5%
Sp2 Tibial Radel Impactor	1	2	0%	99.5%
Tibial Articular Surface Provisional Left Size Gh	1	0	0%	99.2%
Triathlon Ps X3 Tibial Insert	1	21	0%	12.9%
Unknown Bearing	1	84	0.3%	2.2%
Unknown NexGen Articular Surface	1	26	0%	0.8%
Unknown Patella	1	13	1.1%	0%
Unknown Zimmer Knee	1	0	0%	6.4%

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
Onkos Surgical	2,307	24.5%
Stanmore Implants Worldwide	1,236	13.1%
Stryker Orthopaedics-Mahwah	868	9.2%
Aesculap	358	3.8%
Medacta International	285	3%
Biomet Orthopedics	143	1.5%
Smith & Nephew Orthopaedics	91	1%
Wright Medical Technology	86	0.9%
Stryker Orthopaedics Limerick	82	0.9%
Depuy-Raynham A Division Of Depuy Orthopaedics	49	0.5%
Zimmer	35	0.4%
1219655 Depuy-Raynham A Div Of Depuy Orthopaedic	33	0.4%
Depuy-Raynham A Div Of Depuy Orthopaedics	21	0.2%
Howmedica Osteonics	12	0.1%
Biomet	10	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

Death0.6%54

Injury88.7%8,346

Malfunction10.5%984

Other0.1%14

Not given0.1%14

Who filed

Manufacturer report97.5%9,181

Voluntary report0.1%13

User facility report0%0

Distributor report2.2%203

Not given0.2%15

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	1,491	15.8%
Fracturea broken bone	915	9.7%
Device dislodged or dislocated	412	4.4%
Loss of osseointegration	381	4%
Breakthe device broke	372	4%
Loosening of implant not related to bone-ingrowth	314	3.3%
Unstable	312	3.3%
Detachment of device or device componentpart of the device came off	267	2.8%
Naturally worn	228	2.4%
Explanted	148	1.6%
Loose or intermittent connection	144	1.5%
Device appears to trigger rejection	134	1.4%
Migration or expulsion of device	121	1.3%
Mechanical problema mechanical problem	109	1.2%
Patient-device incompatibilitythe device did not suit the patient	97	1%
Patient device interaction problem	86	0.9%
Degraded	80	0.8%
Disassembly	77	0.8%
Migrationthe device moved from where it was placed	77	0.8%
Implant, removal of	69	0.7%

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

What is product code KRO?

FDA's classification code for "Prosthesis, knee, femorotibial, 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?

9,412 reports through August 2026, 933 of them in the latest 12 months.

Which brands appear most often?

Eleos (951), ELEOS Limb Salvage System (940), Unknown Femoral Component (7), Unknown Stryker knee (7) and Unknown Knee (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.