Reported Reactions

Devices › Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Device brand name · Hip component

Acetabular Component: medical device reports filed with FDA

189 reports name it, 2016–2019. Manufacturer given most often on reports: Microport Orthopedics. Product code LZO.

189
device reports naming the brand
0% of all MAUDE reports · about 19 a year
0
reports, 12 months to August 2026
0 in the 12 months before
1.1%
classified as malfunction
9.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 189 reports that name the brand "Acetabular Component" (hip component), received between October 2016 and July 2019; the manufacturer given most often on reports is Microport Orthopedics. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none 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 (98.4%) and malfunction (1.1%); across all prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented reports (product code LZO) death is recorded in 0.2% and malfunction in 9.1%. 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 (93.7%), data problem (0.5%) and device dislodged or dislocated (0.5%). The patient problems coded most often are reaction, metal related pathology and reinfusion. 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

No report naming Acetabular Component was received in the five years to August 2026; the latest was received in July 2019.

By year received

0741482016: 320162017: 420172018: 3420182019: 1482019

Event type and report source

Event type, as classified on the report

Death0%0
Injury98.4%186
Malfunction1.1%2
Other0%0
Not given0.5%1

Who filed the report

Manufacturer report100%189
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 32,865 reports carrying product code LZO. 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 information17793.7%18.4%
Data problem10.5%0%
Device dislodged or dislocated10.5%18.4%
Loose or intermittent connection10.5%1.9%

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 specified9952.4%
Metal related pathology21.1%
Reinfusion21.1%

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

In context

MeasureAcetabular ComponentProduct code LZOAll MAUDE reports
Reports18932,86526,136,888
Share of that pool—0.6%0%
Classified as death, per 1,000 reports029
Classified as injury98.4%89.9%36.2%
Classified as malfunction1.1%9.1%62.3%
Filed by the manufacturer100%98.3%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 LZO

BrandReportsLatest 12 monthsClassified as death
Delta Cer Head 12/14 36mm +1 51,191590%
Delta Cer Head 12/14 36mm +5914470%
Delta Cer Head 12/14 32mm +1789390%
Biolox Delta Hip54900%
Delta Cer Head 12/14 32mm +5439120.2%
Unknown Head2,2501030.7%
BIOLOX Delta3692550%
Delta Cer Head 12/14 36mm +8 5362220%
UNK Hip Femoral Stem Corail523560.8%
Trinity673600.1%
Dlt Ts Cer Hd 12/14 36mm +1 531020%
Mectacer Biolox Delta Femoral Ball Head2241160%
Modular Dual Mobility Insert24960%
Delta Cer Head 12/14 28mm +1 5232130%
Dlt Ts Cer Hd 12/14 36mm +5 029670.3%

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 Acetabular Component reports

How many FDA reports name Acetabular Component?

189 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (98.4%) and malfunction (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (93.7%), data problem (0.5%), device dislodged or dislocated (0.5%) and loose or intermittent connection (0.5%). 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 Acetabular Component 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.