Prosthesis, hip, semi-constrained (metal uncemented acetabular component): medical device reports filed with FDA

138,213 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.

138,213
reports with this product code: 0.5% of all MAUDE reports; 1,195
reports, 12 months to August 2026: 1,144 in the 12 months before; 3.4%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code KWA is FDA's classification for "Prosthesis, hip, semi-constrained (metal uncemented acetabular component)" (orthopedic panel), a class 3 device. 138,213 medical device reports carry this product code, 0.5% of the MAUDE database, from December 1992 to August 2026.

1,195 reports arrived in the 12 months to August 2026, close to the 1,144 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 (94.3%), malfunction (3.4%) and other (1.7%). 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
Pinnacle Mtl Ins Neut36idx52od	3,645	13	0.1%	5.1%
Pinnacle Mtl Ins Neut36idx54od	2,800	11	0.1%	4.7%
Asr Acetabular Cups 52	2,419	2	0.1%	0%
Asr Uni Femoral Impl Size 46	2,413	2	0.1%	0.2%
Asr Acetabular Cups 54	2,339	0	0.4%	0.1%
Asr Uni Femoral Impl Size 47	2,308	0	0.4%	0.1%
Asr Acetabular Cups 56	2,202	0	0.4%	0.1%
Asr Uni Femoral Impl Size 49	2,179	0	0.4%	0%
Asr Acetabular Cups 50	2,048	0	0.1%	0%
Asr Uni Femoral Impl Size 45	2,036	0	0.1%	0.1%
Pinnacle Mtl Ins Neut36idx50od	2,035	9	0%	3.6%
Unknown Hip Acetabular Liners	1,963	260	0.2%	3.2%
Durom Acetabular Component	1,953	0	0.1%	0.1%
Unknown Hip Acetabular Cup	1,924	106	0.4%	6.1%
Unknown Depuy Asr Acetabular Cup	1,834	0	0.2%	0.3%
Pinnacle Mtl Ins Neut40idx56od	1,743	6	0.1%	3.8%
Asr Acetabular Cups 58	1,526	1	0.5%	0.1%
Asr Uni Femoral Impl Size 51	1,495	1	0.4%	0.1%
Conserve R Plus Cup	1,315	0	0%	0.2%
Asr Acetabular Cups 48	1,311	0	0.3%	0%
Asr Uni Femoral Impl Size 43	1,308	0	0.3%	0.2%
Adapter Sleeves 12/14 +2	1,275	5	0.4%	7%
Pinnacle Mtl Ins Neut36idx56od	1,259	5	0.2%	4.7%
Total Asr Acet Imp Size 56	997	0	0.5%	0.5%
Total Asr Acet Imp Size 54	994	0	0.7%	0.2%
Total Asr Acet Imp Size 52	982	0	0.7%	0.5%
Asr Acetabular Implant 52	965	3	0%	1.9%
Pinnacle Mtl Ins Neut40idx58od	937	0	0.3%	4.1%
Asr Acetabular Implant 54	934	4	0.1%	1.7%
Unknown Depuy Asr Femoral Head	928	0	0.2%	0.5%

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
Depuy International	35,582	25.7%
Depuy Orthopaedics US	15,462	11.2%
Biomet Orthopedics	12,554	9.1%
Depuy International 8010379	10,376	7.5%
Zimmer	8,773	6.3%
Depuy Orthopaedics 1818910	7,418	5.4%
Zimmer Biomet	7,368	5.3%
Depuy Intl - 8010379	6,435	4.7%
Depuy International - 8010379	6,177	4.5%
Depuy Orthopaedics	4,229	3.1%
Microport Orthopedics	3,424	2.5%
Wright Medical Technology	1,784	1.3%
Depuy Intl	1,723	1.2%
Depuy France Sas - 3003895575	1,536	1.1%
Depuy International -8010379	1,285	0.9%

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%388

Injury94.3%130,379

Malfunction3.4%4,726

Other1.7%2,303

Not given0.3%417

Who filed

Manufacturer report99.2%137,161

Voluntary report0.6%840

User facility report0%0

Distributor report0%34

Not given0.1%178

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	71,931	52%
Metal shedding debris	10,500	7.6%
Naturally worn	9,249	6.7%
Device dislodged or dislocated	7,217	5.2%
Loss of osseointegration	7,114	5.1%
Noise, audible	4,490	3.2%
Nonstandard device	2,836	2.1%
Corrodedthe device corroded	2,814	2%
Malposition of device	1,971	1.4%
Material erosion	1,858	1.3%
Material disintegration	1,794	1.3%
Fracturea broken bone	1,731	1.3%
Loose or intermittent connection	1,686	1.2%
Loss of or failure to bond	1,664	1.2%
Implant, removal of	1,622	1.2%
Device slipped	1,563	1.1%
Migration or expulsion of device	1,406	1%
Device operates differently than expectedthe device behaved unexpectedly	1,358	1%
Osseointegration problem	1,086	0.8%
Loose	930	0.7%

Questions about prosthesis, hip, semi-constrained (metal uncemented acetabular component) reports

What is product code KWA?

FDA's classification code for "Prosthesis, hip, semi-constrained (metal uncemented acetabular component)", class 3, reviewed by the orthopedic panel. Every device report carries the product code of the device involved.

How many reports carry this code?

138,213 reports through August 2026, 1,195 of them in the latest 12 months.

Which brands appear most often?

Pinnacle Mtl Ins Neut36idx52od (3,645), Pinnacle Mtl Ins Neut36idx54od (2,800), Asr Acetabular Cups 52 (2,419), Asr Uni Femoral Impl Size 46 (2,413) and Asr Acetabular Cups 54 (2,339). 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.