Reported Reactions

Devices › Prosthesis, hip, semi-constrained (metal uncemented acetabular component)

Device brand name · Hip component

Conserve Plus Cup: medical device reports filed with FDA

172 reports name it, 2005–2026. Manufacturer given most often on reports: Microport Orthopedics. Product code KWA.

172
device reports naming the brand
0% of all MAUDE reports · about 8 a year
4
reports, 12 months to August 2026
1 in the 12 months before
0.6%
classified as malfunction
3.4% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

172 medical device reports received by FDA name the brand "Conserve Plus Cup" (hip component); the manufacturer given most often on reports is Microport Orthopedics; received from January 2005 to June 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

4 reports arrived in the 12 months to August 2026, up 300% from 1 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 (98.3%) and malfunction (0.6%); across all prosthesis, hip, semi-constrained (metal uncemented acetabular component) reports (product code KWA) death is recorded in 0.3% and malfunction in 3.4%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are insufficient device problem information (21.5%), material disintegration (12.8%) and loose (10.5%). The patient problems coded most often are reaction, metal related pathology and pain. 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."

Reports by month, five years

023Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 2Feb 2022: 0Mar 2022: 2Apr 2022: 3May 2022: 2Jun 2022: 2Jul 2022: 0Aug 2022: 1Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 1Apr 2023: 0May 2023: 0Jun 2023: 1Jul 2023: 1Aug 2023: 1Sep 2023: 0Oct 2023: 1Nov 2023: 0Dec 2023: 12024Jan 2024: 0Feb 2024: 1Mar 2024: 0Apr 2024: 0May 2024: 1Jun 2024: 1Jul 2024: 0Aug 2024: 0Sep 2024: 0Oct 2024: 1Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 0Apr 2025: 0May 2025: 0Jun 2025: 0Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 1Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 3Jul 2026: 0Aug 2026: 0

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

018362005: 320052008: 212009: 2320092010: 52016: 520162017: 32018: 320182019: 322020: 3620202021: 152022: 1220222023: 62024: 420242026: 4

Event type and report source

Event type, as classified on the report

Death0%0
Injury98.3%169
Malfunction0.6%1
Other0%0
Not given1.2%2

Who filed the report

Manufacturer report100%172
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 138,213 reports carrying product code KWA. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Insufficient device problem information3721.5%52%
Material disintegration2212.8%1.3%
Loose1810.5%0.7%
Loss of osseointegration1810.5%5.1%
Corrodedthe device corroded63.5%2%
Loose or intermittent connection42.3%1.2%
Breakthe device broke21.2%0.5%
Device dislodged or dislocated21.2%5.2%
Failure to osseointegrate21.2%0.1%
Naturally worn21.2%6.7%
Noise, audible21.2%3.2%
Drift10.6%0%
Loosening of implant not related to bone-ingrowth10.6%0.2%
Malposition of device10.6%1.4%
Material erosion10.6%1.3%
Material fragmentation10.6%0%
Migration or expulsion of device10.6%1%
Output problem10.6%0%
Patient-device incompatibilitythe device did not suit the patient10.6%0.4%
Unstable10.6%0.3%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Reactiona reaction, type not specified4325%
Metal related pathology3118%
Painpain, site not specified3118%
Loss of range of motion105.8%
Osteolysis42.3%
Fluid discharge21.2%
Embolism/embolus10.6%
Extraskeletal ossification10.6%
Extubate10.6%
Hematomaa collection of blood under the skin or in tissue10.6%
Hypersensitivity/allergic reaction10.6%
Inflammationinflammation10.6%
Keratitis10.6%
Neuropathy10.6%
Osteopenia/ osteoporosis10.6%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasureConserve Plus CupProduct code KWAAll MAUDE reports
Reports172138,21326,136,888
Share of that pool—0.1%0%
Classified as death, per 1,000 reports039
Classified as injury98.3%94.3%36.2%
Classified as malfunction0.6%3.4%62.3%
Filed by the manufacturer100%99.2%94.9%

Shares are of reports, not of devices in use. 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."

Other brands with product code KWA

BrandReportsLatest 12 monthsClassified as death
Pinnacle Mtl Ins Neut36idx52od3,720130.1%
Pinnacle Mtl Ins Neut36idx54od2,874110.1%
Asr Acetabular Cups 522,42820.1%
Asr Uni Femoral Impl Size 462,50020.1%
Asr Acetabular Cups 542,35000.4%
Asr Uni Femoral Impl Size 472,42300.4%
Asr Acetabular Cups 562,20600.4%
Asr Uni Femoral Impl Size 492,27800.4%
Asr Acetabular Cups 502,05600.1%
Asr Uni Femoral Impl Size 452,11900.1%
Pinnacle Mtl Ins Neut36idx50od2,06690%
Unknown Hip Acetabular Liners4,8142600.2%
Durom Acetabular Component2,07100.1%
Unknown Hip Acetabular Cup3,2151060.4%
Unknown Depuy Asr Acetabular Cup1,93300.2%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Conserve Plus Cup reports

How many FDA reports name Conserve Plus Cup?

172 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 4 in the latest 12 months.

What kinds of events are reported?

injury (98.3%) and malfunction (0.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (21.5%), material disintegration (12.8%), loose (10.5%), loss of osseointegration (10.5%) and corroded (3.5%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Conserve Plus Cup was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.