Devices › Prosthesis, hip, semi-constrained, metal/polymer, cemented
Device brand name · Prosthesis hip
Unknown Shell: medical device reports filed with FDA
303 reports name it, 2015–2026. Manufacturer given most often on reports: Zimmer Biomet. Product code JDI.
- 303
- device reports naming the brand
- 0% of all MAUDE reports · about 28 a year
- 3
- reports, 12 months to August 2026
- 20 in the 12 months before
- 6.3%
- classified as malfunction
- 7.8% across the product code
- 1%
- classified as death, as reported
- 3 reports · not verified by FDA
303 medical device reports received by FDA name the brand "Unknown Shell" (prosthesis hip); the manufacturer given most often on reports is Zimmer Biomet; received from October 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
3 reports arrived in the 12 months to August 2026, down 85% from 20 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 (92.7%), malfunction (6.3%) and death (1%); across all prosthesis, hip, semi-constrained, metal/polymer, cemented reports (product code JDI) death is recorded in 0.4% and malfunction in 7.8%. 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 (38.6%), malposition of device (7.6%) and device dislodged or dislocated (6.9%). The patient problems coded most often are injury, 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
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 70,618 reports carrying product code JDI. 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 | 117 | 38.6% | 30.7% |
| Malposition of device | 23 | 7.6% | 1% |
| Device dislodged or dislocated | 21 | 6.9% | 14.7% |
| Loss of osseointegration | 11 | 3.6% | 2.1% |
| Detachment of device or device componentpart of the device came off | 8 | 2.6% | 0.8% |
| Material erosion | 8 | 2.6% | 1.1% |
| Migration or expulsion of device | 8 | 2.6% | 0.9% |
| Difficult to insertthe device was hard to insert | 7 | 2.3% | 0.6% |
| Fracturea broken bone | 7 | 2.3% | 3.7% |
| Loosening of implant not related to bone-ingrowth | 6 | 2% | 1% |
| Migrationthe device moved from where it was placed | 6 | 2% | 0.7% |
| Degraded | 5 | 1.7% | 1.4% |
| Osseointegration problem | 5 | 1.7% | 0.8% |
| Positioning failure | 5 | 1.7% | 0.1% |
| Positioning problem | 4 | 1.3% | 0.2% |
| Unstable | 4 | 1.3% | 1.1% |
| Mechanical problema mechanical problem | 3 | 1% | 0.4% |
| Naturally worn | 3 | 1% | 11.7% |
| Noise, audible | 3 | 1% | 2.4% |
| Loss of or failure to bond | 2 | 0.7% | 1.2% |
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 |
|---|---|---|
| Injurya physical injury | 53 | 17.5% |
| Painpain, site not specified | 46 | 15.2% |
| Joint dislocationa dislocated joint | 22 | 7.3% |
| Inadequate osseointegration | 16 | 5.3% |
| Osteolysis | 12 | 4% |
| Reactiona reaction, type not specified | 12 | 4% |
| Bone fracture(s) | 10 | 3.3% |
| Failure of implant | 10 | 3.3% |
| Metal related pathology | 10 | 3.3% |
| Impaired healingslow healing | 9 | 3% |
| Ambulation or postural difficulties | 8 | 2.6% |
| Inflammationinflammation | 7 | 2.3% |
| Hematomaa collection of blood under the skin or in tissue | 6 | 2% |
| Falla fall | 5 | 1.7% |
| Joint laxity | 5 | 1.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Shell | Product code JDI | All MAUDE reports |
|---|---|---|---|
| Reports | 303 | 70,618 | 26,136,888 |
| Share of that pool | — | 0.4% | 0% |
| Classified as death, per 1,000 reports | 10 | 4 | 9 |
| Classified as injury | 92.7% | 91.3% | 36.2% |
| Classified as malfunction | 6.3% | 7.8% | 62.3% |
| Filed by the manufacturer | 100% | 98.4% | 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 JDI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Articuleze M Head 36mm +1 5 | 3,431 | 24 | 0.1% |
| Articuleze M Head 36mm +5 | 3,111 | 24 | 0.1% |
| Unknown Hip Femoral Head | 5,080 | 176 | 0.7% |
| Articuleze M Head 36mm -2 | 1,661 | 10 | 0.2% |
| Articuleze M Head 36mm +8 5 | 1,674 | 11 | 0.1% |
| Unknown Hip Femoral Stem | 4,140 | 79 | 0.8% |
| Unknown Hip | 2,306 | 5 | 1.9% |
| Unknown Head | 2,250 | 103 | 0.7% |
| Unknown Stem | 1,857 | 84 | 0.5% |
| Unknown liner | 2,255 | 75 | 0.4% |
| Unknown Reconstructive Product | 2,579 | 0 | 0.4% |
| Articul/Eze Ball 32 +1 Gr | 695 | 5 | 0.1% |
| UNK Hip Femoral Head Metal | 728 | 67 | 0.1% |
| Articul/Eze Ball 28 +1 5 Gr | 641 | 20 | 0.3% |
| S-Rom M Head 36mm +0 | 827 | 0 | 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 Unknown Shell reports
How many FDA reports name Unknown Shell?
303 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3 in the latest 12 months.
What kinds of events are reported?
injury (92.7%), malfunction (6.3%) and death (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 (38.6%), malposition of device (7.6%), device dislodged or dislocated (6.9%), loss of osseointegration (3.6%) and detachment of device or device component (2.6%). 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 Shell 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.