Devices › Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented
Device brand name · Hip component
Lineage R Transcend R Ceramic Femoral Head: medical device reports filed with FDA
164 reports name it, 2005–2018. Manufacturer given most often on reports: Wright Medical Technology. Product code MRA.
- 164
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0%
- classified as malfunction
- 40.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
164 medical device reports received by FDA name the brand "Lineage R Transcend R Ceramic Femoral Head" (hip component); the manufacturer given most often on reports is Wright Medical Technology; received from May 2005 to August 2018. 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 injury (100%); across all prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented reports (product code MRA) death is recorded in 0.2% and malfunction in 40.4%. 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 (20.7%), device dislodged or dislocated (6.7%) and break (4.3%). The patient problems coded most often are pain, reaction 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 Ceramic Femoral Head was received in the five years to August 2026; the latest was received in August 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,347 reports carrying product code MRA. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Insufficient device problem information | 34 | 20.7% | 13.3% |
| Device dislodged or dislocated | 11 | 6.7% | 5.4% |
| Breakthe device broke | 7 | 4.3% | 29.6% |
| Corrodedthe device corroded | 4 | 2.4% | 1% |
| Naturally worn | 4 | 2.4% | 1.5% |
| Detachment of device component | 3 | 1.8% | 0.2% |
| Loose or intermittent connection | 3 | 1.8% | 0.8% |
| Noise, audible | 3 | 1.8% | 4.1% |
| Unstable | 3 | 1.8% | 0.4% |
| Device contaminated during manufacture or shipping | 1 | 0.6% | 0% |
| Expulsion | 1 | 0.6% | 0% |
| Inadequacy of device shape and/or size | 1 | 0.6% | 0.6% |
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) | Reports | Share |
|---|---|---|
| Painpain, site not specified | 23 | 14% |
| Reactiona reaction, type not specified | 16 | 9.8% |
| Joint dislocationa dislocated joint | 8 | 4.9% |
| Osteolysis | 2 | 1.2% |
| Bone fracture(s) | 1 | 0.6% |
| Extraskeletal ossification | 1 | 0.6% |
| Fluid discharge | 1 | 0.6% |
| Granuloma | 1 | 0.6% |
| Hematomaa collection of blood under the skin or in tissue | 1 | 0.6% |
| Scar tissue | 1 | 0.6% |
| Swellingswelling | 1 | 0.6% |
| Toxicity | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Lineage R Transcend R Ceramic Femoral Head | Product code MRA | All MAUDE reports |
|---|---|---|---|
| Reports | 164 | 5,347 | 26,136,888 |
| Share of that pool | — | 3.1% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 100% | 58.8% | 36.2% |
| Classified as malfunction | 0% | 40.4% | 62.3% |
| Filed by the manufacturer | 100% | 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 MRA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Pinn Straight Cup Impactor | 4,807 | 315 | 0% |
| Trident Alumina Insert | 515 | 0 | 0% |
| Srom Stm St 36+6l Nk 11x16x150 | 421 | 1 | 0% |
| Srom Stm St 36+8l Nk 18x13x160 | 660 | 1 | 0% |
| Srom Stm Std 36+12l 13x18 | 369 | 0 | 0.3% |
| Delta Cer Head 12/14 36mm +1 5 | 1,191 | 59 | 0% |
| Delta Cer Head 12/14 36mm +5 | 914 | 47 | 0% |
| Apex Hole Elim Positive Stop | 1,082 | 20 | 0.4% |
| Summit Por Taper Sz6 Std Off | 459 | 4 | 0.4% |
| Summit Por Taper Sz4 Std Off | 392 | 0 | 0.5% |
| Srom Stm Std 36+12l 15x20 | 188 | 0 | 0% |
| Delta Cer Head 12/14 36mm +8 5 | 362 | 22 | 0% |
| Delta Cer Head 12/14 32mm +1 | 789 | 39 | 0% |
| Summit Por Taper Sz5 Hi Off | 483 | 0 | 0.2% |
| Summit Por Taper Sz5 Std Off | 472 | 1 | 0.2% |
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 Lineage R Transcend R Ceramic Femoral Head reports
How many FDA reports name Lineage R Transcend R Ceramic Femoral Head?
164 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 (20.7%), device dislodged or dislocated (6.7%), break (4.3%), corroded (2.4%) and naturally worn (2.4%). 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 Ceramic 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.