Devices › Prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal
Device brand name · Femoral component
Reflection: medical device reports filed with FDA
359 reports name it, 1999–2014. Manufacturer given most often on reports: Smith & Nephew. Product code JDH.
- 359
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 3.6%
- classified as malfunction
- 3.4% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
359 medical device reports received by FDA name the brand "Reflection" (femoral component); the manufacturer given most often on reports is Smith & Nephew; received from October 1999 to December 2014. 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 (94.7%), malfunction (3.6%) and other (0.3%); across all prosthesis, hip, hemi-, trunnion-bearing, femoral, metal/polyacetal reports (product code JDH) death is recorded in 0.2% 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 explanted (22.8%), insufficient device problem information (22%) and device dislodged or dislocated (8.9%). The patient problems coded most often are surgical procedure, repeated, hospitalization required and surgery, prolonged. 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 Reflection was received in the five years to August 2026; the latest was received in December 2014.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,621 reports carrying product code JDH. 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 |
|---|---|---|---|
| Explanted | 82 | 22.8% | 1.8% |
| Insufficient device problem information | 79 | 22% | 33.3% |
| Device dislodged or dislocated | 32 | 8.9% | 13% |
| Replace | 31 | 8.6% | 0.6% |
| Difficult to insertthe device was hard to insert | 21 | 5.8% | 0.5% |
| Dislocated | 21 | 5.8% | 0.6% |
| Loose | 17 | 4.7% | 0.2% |
| Difficult to position | 16 | 4.5% | 0.3% |
| Device remains implanted | 14 | 3.9% | 0% |
| Device slipped | 12 | 3.3% | 5.4% |
| Fracturea broken bone | 12 | 3.3% | 7.6% |
| Fitting problem | 10 | 2.8% | 0.3% |
| Material separation | 8 | 2.2% | 0.3% |
| Component(s), worn | 6 | 1.7% | 0.1% |
| Malfunction | 6 | 1.7% | 0% |
| Other (for use when an appropriate device code cannot be identified) | 6 | 1.7% | 0% |
| Positioning problem | 6 | 1.7% | 0.6% |
| Breakthe device broke | 5 | 1.4% | 5% |
| Device operates differently than expectedthe device behaved unexpectedly | 5 | 1.4% | 1.3% |
| Naturally worn | 4 | 1.1% | 2.6% |
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 |
|---|---|---|
| Surgical procedure, repeated | 55 | 15.3% |
| Hospitalization required | 48 | 13.4% |
| Surgery, prolonged | 44 | 12.3% |
| Surgical procedure | 37 | 10.3% |
| Painpain, site not specified | 27 | 7.5% |
| Osteolysis | 10 | 2.8% |
| Surgical procedure, delayed | 5 | 1.4% |
| Therapy/non-surgical treatment, additional | 5 | 1.4% |
| Falla fall | 4 | 1.1% |
| Joint dislocationa dislocated joint | 4 | 1.1% |
| Arthralgiajoint pain | 2 | 0.6% |
| Bone fracture(s) | 2 | 0.6% |
| Hip fracturea broken hip | 2 | 0.6% |
| Allergic reactionan allergic reaction | 1 | 0.3% |
| Bleeding | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Reflection | Product code JDH | All MAUDE reports |
|---|---|---|---|
| Reports | 359 | 2,621 | 26,136,888 |
| Share of that pool | — | 13.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 94.7% | 96% | 36.2% |
| Classified as malfunction | 3.6% | 3.4% | 62.3% |
| Filed by the manufacturer | 100% | 99.5% | 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 JDH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Hip Implant | 355 | 0 | 1.1% |
| Plus | 276 | 0 | 0.4% |
| Synergy | 14,271 | 84 | 3.5% |
| Echelon | 1,352 | 584 | 3.2% |
| R3 | 424 | 0 | 0.2% |
| Unkn Orthopaedic Reconstruction Dev | 239 | 17 | 0.4% |
| Unkn Birmingham Hip Resurfacing Bhr Cup Unkn Type | 227 | 0 | 0.9% |
| Femoral Head | 303 | 11 | 0% |
| Unknown Hip Implant | 1,114 | 9 | 0.6% |
| Knee Implant | 497 | 0 | 0% |
| Accord Dual Ended Hex Driver | 175 | 0 | 0% |
| Femoral Head Impactor | 185 | 9 | 0% |
| Marathon | 506 | 66 | 5.9% |
| Mi Z Handle Acet Reamer | 458 | 22 | 0% |
| R3 Straight Shell Impactor | 565 | 21 | 0% |
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 Reflection reports
How many FDA reports name Reflection?
359 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 (94.7%), malfunction (3.6%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (22.8%), insufficient device problem information (22%), device dislodged or dislocated (8.9%), replace (8.6%) and difficult to insert (5.8%). 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 Reflection 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.