Reported Reactions

Devices › Orthopedic manual surgical instrument

Device brand name · Hip instruments

Unknown Hip Instruments: medical device reports filed with FDA

182 reports name it, 2017–2021. Manufacturer given most often on reports: Depuy Orthopaedics 1818910. Product code LXH.

182
device reports naming the brand
0% of all MAUDE reports · about 21 a year
0
reports, 12 months to August 2026
0 in the 12 months before
56%
classified as malfunction
90.1% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

182 medical device reports received by FDA name the brand "Unknown Hip Instruments" (hip instruments); the manufacturer given most often on reports is Depuy Orthopaedics 1818910; received from September 2017 to April 2021. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 malfunction (56%) and injury (44%); across all orthopedic manual surgical instrument reports (product code LXH) death is recorded in 0.1% and malfunction in 90.1%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are break (45.1%), fracture (19.2%) and insufficient device problem information (2.2%). The patient problems coded most often are bone fracture(s), not applicable and foreign body in patient. 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 Unknown Hip Instruments was received in the five years to August 2026; the latest was received in April 2021.

By year received

0501002017: 520172018: 10020182019: 7420192021: 32021

Event type and report source

Event type, as classified on the report

Death0%0
Injury44%80
Malfunction56%102
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%182
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 81,663 reports carrying product code LXH. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Breakthe device broke8245.1%43.5%
Fracturea broken bone3519.2%8.5%
Insufficient device problem information42.2%1.1%
Naturally worn42.2%2.4%
Device-device incompatibility31.6%7.5%
Crackthe device cracked21.1%3.2%
Defective devicethe device was defective21.1%0.3%
Device contamination with chemical or other material21.1%0.3%
Difficult to removethe device was hard to remove21.1%1.3%
Loose or intermittent connection21.1%0.6%
Material fragmentation21.1%1.4%
Component missing10.5%1%
Connection problema connection problem10.5%0.4%
Detachment of device or device componentpart of the device came off10.5%2.5%
Device fell10.5%0%
Device issuea problem with the device10.5%0.1%
Entrapment of device10.5%0.4%
Improper or incorrect procedure or method10.5%0.2%
Patient device interaction problem10.5%0.1%
Physical resistance/sticking10.5%1.1%

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
Bone fracture(s)6234.1%
Not applicable2614.3%
Foreign body in patientpart of a device left in the patient31.6%
Painpain, site not specified21.1%
Myocardial infarctionheart attack10.5%
Thrombosis10.5%
Tissue damage10.5%

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

In context

MeasureUnknown Hip InstrumentsProduct code LXHAll MAUDE reports
Reports18281,66326,136,888
Share of that pool—0.2%0%
Classified as death, per 1,000 reports019
Classified as injury44%9.2%36.2%
Classified as malfunction56%90.1%62.3%
Filed by the manufacturer100%98.6%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 LXH

BrandReportsLatest 12 monthsClassified as death
Excel T-Handle2,3681500%
Driving Cap/Threaded1,181580%
Orthopedic Manual Surgical Instrument1,14300.2%
Manual Orthopedic Surgical Instrument1,69300.1%
METRx System1,6792670.1%
Glenosphere Inserter Tip8121750%
Baseplate Inserter Rod5611050%
1.5mm Hex Driver Tip, Locking Groove5803320%
R3 Straight Shell Impactor565210%
Driving Cap497650%
5mm Hex Flexible Screwdriver498600.2%
Attune Mod Post Saw Cap Sz 6-8486410%
Exactech57600%
Attune Femoral Impactor3,3281210%
Metrx41530%

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 Unknown Hip Instruments reports

How many FDA reports name Unknown Hip Instruments?

182 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?

malfunction (56%) and injury (44%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

break (45.1%), fracture (19.2%), insufficient device problem information (2.2%), naturally worn (2.2%) and device-device incompatibility (1.6%). 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 Unknown Hip Instruments 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.