Reported Reactions

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

Device brand name · Hip component

Lineage R Transcend R Superfinished Femoral Head: medical device reports filed with FDA

177 reports name it, 2010–2018. Manufacturer given most often on reports: Microport Orthopedics. Product code JDL.

177
device reports naming the brand
0% of all MAUDE reports · about 11 a year
0
reports, 12 months to August 2026
0 in the 12 months before
0%
classified as malfunction
1.2% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 177 reports that name the brand "Lineage R Transcend R Superfinished Femoral Head" (hip component), received between July 2010 and October 2018; 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 (100%); across all prosthesis, hip, semi-constrained (metal cemented acetabular component) reports (product code JDL) death is recorded in 0.2% and malfunction in 1.2%. 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 (36.2%), device dislodged or dislocated (19.2%) and break (2.8%). The patient problems coded most often are reaction, pain and joint dislocation. 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 Lineage R Transcend R Superfinished Femoral Head was received in the five years to August 2026; the latest was received in October 2018.

By year received

017342010: 620102011: 1220112012: 1620122013: 3420132014: 2720142015: 2220152016: 2420162017: 2420172018: 122018

Event type and report source

Event type, as classified on the report

Death0%0
Injury100%177
Malfunction0%0
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%177
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 3,887 reports carrying product code JDL. 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 information6436.2%44.2%
Device dislodged or dislocated3419.2%5.7%
Breakthe device broke52.8%1.7%
Metal shedding debris52.8%4.2%
Corrodedthe device corroded42.3%3.8%
Detachment of device component42.3%0.4%
Loose or intermittent connection31.7%2.2%
Naturally worn31.7%7.6%
Noise, audible31.7%1.4%
Unstable31.7%0.9%
Material separation21.1%0.1%
Detachment of device or device componentpart of the device came off10.6%0.5%
Device markings/labelling problema problem with the device markings or label10.6%0%
Device slipped10.6%1.1%
Difficult to removethe device was hard to remove10.6%0.2%
Fracturea broken bone10.6%1.4%
Malposition of device10.6%1%
Material deformation10.6%0%
Material frayed10.6%0.1%
Migration or expulsion of device10.6%0.7%

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 specified3218.1%
Painpain, site not specified2614.7%
Joint dislocationa dislocated joint105.6%
Bone fracture(s)21.1%
Falla fall21.1%
Hematomaa collection of blood under the skin or in tissue21.1%
Hip fracturea broken hip21.1%
Host-tissue reaction21.1%
Inflammationinflammation21.1%
Post operative wound infection21.1%
Test result21.1%
Toxicity21.1%
Arthralgiajoint pain10.6%
Dementiadementia10.6%
Joint disorder10.6%

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

In context

MeasureLineage R Transcend R Superfinished Femoral HeadProduct code JDLAll MAUDE reports
Reports1773,88726,136,888
Share of that pool—4.6%0%
Classified as death, per 1,000 reports029
Classified as injury100%98.1%36.2%
Classified as malfunction0%1.2%62.3%
Filed by the manufacturer100%98.9%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 JDL

BrandReportsLatest 12 monthsClassified as death
Conserve R Total A-Class Head1,36900%
Dynasty R Cocr Liner27000%
Head27800%
Dynasty R A-Class R Poly Liner22100.5%
Femoral Head303110%
Conserve R Total Head W/Bfh46500%
Enduron 10d 54od X 28id20300%
Enduron 10d 56 Or 68odx28id15920%
Femoral Head Biolox Delta17000%
Conserve R Plus Cup1,32800%
Enduron 10d 52od X 28id17700%
Profemur R Modular Femoral Neck1,75600.1%
Acetabular Component18900%
Articul/Eze Ball 28 +8 5 Bl387130.3%
Cocr Femoral Head17540%

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 Lineage R Transcend R Superfinished Femoral Head reports

How many FDA reports name Lineage R Transcend R Superfinished Femoral Head?

177 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 (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (36.2%), device dislodged or dislocated (19.2%), break (2.8%), metal shedding debris (2.8%) and corroded (2.3%). 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 Lineage R Transcend R Superfinished Femoral Head 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.