Prosthesis, hip, femoral, resurfacing: medical device reports filed with FDA

12,511 reports carry this product code, 1992–2026; 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.

12,511
reports with this product code: 0.1% of all MAUDE reports; 19
reports, 12 months to August 2026: 8 in the 12 months before; 2.2%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code KXA is FDA's classification for "Prosthesis, hip, femoral, resurfacing" (orthopedic panel), a class 2 device. 12,511 medical device reports carry this product code, 0.1% of the MAUDE database, from July 1992 to July 2026.

19 reports arrived in the 12 months to August 2026, up 138% from 8 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 (97.3%), malfunction (2.2%) and death (0.3%). 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
Unknown Depuy Asr Femoral Head	1,331	0	0.2%	0.5%
Depuy Asr Xl Fem Imp Size 46	509	0	0.5%	0.5%
Depuy Asr Xl Fem Imp Size 47	509	4	0.5%	0.4%
Depuy Asr Xl Fem Imp Size 49	440	0	0.4%	0.4%
Depuy Asr Xl Fem Imp Size 45	436	1	0.3%	0.3%
Total Asr Fem Imp Size 51	417	0	0.3%	0.1%
Unknown Depuy Asr Head	415	0	0.4%	0.3%
Depuy Asr Xl Fem Imp Size 51	370	0	0.9%	0.2%
Unknown Hip Femoral Stem	369	79	0.8%	6.6%
Total Asr Fem Imp Size 49	363	0	0%	1.3%
Unknown Hip Femoral Head	340	176	0.7%	2%
Total Asr Fem Imp Size 47	322	0	0%	0.5%
Total Asr Fem Imp Size 46	312	0	0%	0.4%
Total Asr Fem Imp Size 53	279	0	0%	0.2%
Total Asr Fem Imp Size 45	236	0	0%	0.5%
Depuy Asr Xl Fem Imp Size 43	230	0	0.3%	0.6%
Depuy Asr Xl Fem Imp Size 53	190	0	1.2%	0.4%
Conserve R Super Finish Femoral	185	0	0%	0%
Total Asr Fem Imp Size 43	161	0	0.4%	0.7%
Unknown Depuy Femoral Head	152	0	0.1%	0.6%
Unknown Depuy Femoral Stem	145	0	0.1%	5.4%
Total Asr Fem Imp Size 55	137	0	0.9%	0%
Unidentified Asr Head	128	0	2.4%	0%
Asr Uni Femoral Impl Size 47	105	0	0.4%	0.1%
Depuy Asr Xl Fem Imp Size 41	94	0	0%	0%
Depuy Asr Xl Fem Imp Size 55	94	0	0.4%	0%
Unknown Hip Femoral Augment	89	0	0.4%	0.7%
Asr Uni Femoral Impl Size 49	85	0	0.4%	0%
Asr Uni Femoral Impl Size 46	78	2	0.1%	0.2%
Asr Uni Femoral Impl Size 45	71	0	0.1%	0.1%

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 International	3,135	25.1%
Depuy International 8010379	2,976	23.8%
Depuy Intl - 8010379	1,816	14.5%
Depuy International - 8010379	986	7.9%
Depuy Orthopaedics US	692	5.5%
Depuy Orthopaedics	258	2.1%
Depuy International -8010379	173	1.4%
Microport Orthopedics	162	1.3%
Depuy Orthopaedics 1818910	143	1.1%
1818910 Depuy Orthopaedics	113	0.9%
Biomet Orthopedics	108	0.9%
Wright Medical Technology	104	0.8%
Depuy Intl 8010379	91	0.7%
Biomet UK	43	0.3%
Depuy Intl	40	0.3%

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%40

Injury97.3%12,175

Malfunction2.2%273

Other0%6

Not given0.1%17

Who filed

Manufacturer report99%12,385

Voluntary report0.7%91

User facility report0%0

Distributor report0.1%11

Not given0.2%24

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	7,580	60.6%
Metal shedding debris	805	6.4%
Loss of osseointegration	652	5.2%
Device dislodged or dislocated	576	4.6%
Noise, audible	572	4.6%
Naturally worn	231	1.8%
Loss of or failure to bond	184	1.5%
Corrodedthe device corroded	169	1.4%
Migrationthe device moved from where it was placed	152	1.2%
Fracturea broken bone	138	1.1%
Malposition of device	105	0.8%
Nonstandard device	83	0.7%
Loose or intermittent connection	73	0.6%
Osseointegration problem	54	0.4%
Degraded	50	0.4%
Device slipped	39	0.3%
Material erosion	33	0.3%
Breakthe device broke	31	0.2%
Migration or expulsion of device	31	0.2%
Device operates differently than expectedthe device behaved unexpectedly	30	0.2%

Questions about prosthesis, hip, femoral, resurfacing reports

What is product code KXA?

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

How many reports carry this code?

12,511 reports through August 2026, 19 of them in the latest 12 months.

Which brands appear most often?

Unknown Depuy Asr Femoral Head (1,331), Depuy Asr Xl Fem Imp Size 46 (509), Depuy Asr Xl Fem Imp Size 47 (509), Depuy Asr Xl Fem Imp Size 49 (440) and Depuy Asr Xl Fem Imp Size 45 (436). 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.