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

2,689 reports carry this product code, 1994–2026; 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.

2,689
reports with this product code: 0% of all MAUDE reports; 49
reports, 12 months to August 2026: 37 in the 12 months before; 22.7%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code KWL is FDA's classification for "Prosthesis, hip, hemi-, femoral, metal" (orthopedic panel), a class 2 device. 2,689 medical device reports carry this product code, 0% of the MAUDE database, from February 1994 to August 2026.

49 reports arrived in the 12 months to August 2026, up 32% from 37 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 (75.7%), malfunction (22.7%) and other (1.3%). 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
Actis Broach Sz 5	44	15	0%	97.9%
Foundation Hip	40	0	0%	2.2%
Adapter Sleeve 11/13 +0	38	0	0.5%	8.1%
Actis Broach Sz 4	32	8	0%	97%
Corail2 Std Size 11	30	2	0.5%	3.2%
Corail Amt Collar Size 12	28	2	0.3%	5.6%
Actis Broach Sz 6	27	27	0%	96.9%
Corail Amt Collar Size 10	27	0	0%	2.5%
Corail Amt Collar Size 11	27	2	0%	4.3%
Corail2 Non Col Ho Size 12	24	2	0.3%	2.5%
Actis Broach Sz 7	23	12	0%	100%
Corail2 Std Size 12	20	3	0.4%	5.8%
Corail2 Std Size 8	16	0	0%	1.6%
Corail2 Lat Coxa Vara Size 11	15	1	0.6%	5.1%
Corail Amt Collar Size 13	13	2	0%	6.3%
Corail2 Non Col Ho Size 13	13	1	0%	3.6%
Actis Retaining Stem Inserter	12	26	0%	100%
Corail2 Non Col Ho Size 11	11	2	0%	2.8%
Corail2 Std Size 9	10	0	0.4%	0.8%
Corail2 Non Col Ho Size 10	8	0	0%	1.5%
Corail2 Std Size 13	7	0	1.6%	1.6%
Corail2 Std Size 10	6	0	0.3%	1.5%
Cormet	3	0	0%	1.9%
Unknown Femoral Stem	3	10	1.3%	0.4%
Tritanium Revision Acetabular	2	0	0.5%	5.6%
Acetlr Cup Hap 52mm W/ Imptr	1	0	0%	0.6%
Adapter Sleeves 12/14 +8	1	0	0.3%	9.3%
Artic/Eze Tr Ball Grvd 32+1	1	1	0%	97.5%
Asr Acetabular Cups 50	1	0	0.1%	0%
Asr Tap Slv Adap 12/14 -1	1	0	0%	7.7%

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 Ireland - 9616671	423	15.7%
Smith & Nephew Orthopaedics	196	7.3%
Stryker Orthopaedics-Mahwah	195	7.3%
Depuy France Sas 3003895575	127	4.7%
Microport Orthopedics	102	3.8%
Depuy France Sas - 3003895575	91	3.4%
Depuy Ireland 9616671	83	3.1%
Stryker Orthopaedics Mahwah	57	2.1%
Depuy International 8010379	35	1.3%
Depuy Orthopaedics US	30	1.1%
Encore Medical L P	18	0.7%
Depuy International - 8010379	16	0.6%
Depuy Intl 8010379	11	0.4%
Stryker Orthopaedics Cork	9	0.3%
Depuy International	6	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%4

Injury75.7%2,035

Malfunction22.7%610

Other1.3%36

Not given0.1%4

Who filed

Manufacturer report99%2,662

Voluntary report0.5%14

User facility report0%0

Distributor report0.1%4

Not given0.3%9

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	594	22.1%
Loss of osseointegration	250	9.3%
Device-device incompatibility	204	7.6%
Device dislodged or dislocated	190	7.1%
Breakthe device broke	143	5.3%
Biocompatibility	117	4.4%
Material twisted/bent	113	4.2%
Fracturea broken bone	80	3%
Corrodedthe device corroded	78	2.9%
Scratched material	75	2.8%
Fitting problem	60	2.2%
Migration or expulsion of device	59	2.2%
Naturally worn	55	2%
Loose or intermittent connection	52	1.9%
Explanted	48	1.8%
Degraded	38	1.4%
Loss of or failure to bond	36	1.3%
Implant, removal of	35	1.3%
Osseointegration problem	35	1.3%
Nonstandard device	32	1.2%

Questions about prosthesis, hip, hemi-, femoral, metal reports

What is product code KWL?

FDA's classification code for "Prosthesis, hip, hemi-, femoral, metal", class 2, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,689 reports through August 2026, 49 of them in the latest 12 months.

Which brands appear most often?

Actis Broach Sz 5 (44), Foundation Hip (40), Adapter Sleeve 11/13 +0 (38), Actis Broach Sz 4 (32) and Corail2 Std Size 11 (30). 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.