Devices › Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
Device brand name · Pinnacle hip system hip constrained acetabular liners
Pinn Lnr Con +4 Neut 28idx50od: medical device reports filed with FDA
152 reports name it, 2010–2026. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code KWZ.
- 152
- device reports naming the brand
- 0% of all MAUDE reports · about 9 a year
- 7
- reports, 12 months to August 2026
- 5 in the 12 months before
- 11.2%
- classified as malfunction
- 9.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
152 medical device reports received by FDA name the brand "Pinn Lnr Con +4 Neut 28idx50od" (pinnacle hip system hip constrained acetabular liners); the manufacturer given most often on reports is Depuy Orthopaedics US; received from January 2010 to April 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
7 reports arrived in the 12 months to August 2026, up 40% from 5 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 (88.8%) and malfunction (11.2%); across all prosthesis, hip, constrained, cemented or uncemented, metal/polymer reports (product code KWZ) death is recorded in 0.4% and malfunction in 9.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device dislodged or dislocated (32.2%), fracture (3.9%) and insufficient device problem information (3.3%). The patient problems coded most often are joint dislocation, joint laxity and pain. 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 5,692 reports carrying product code KWZ. 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 |
|---|---|---|---|
| Device dislodged or dislocated | 49 | 32.2% | 34.5% |
| Fracturea broken bone | 6 | 3.9% | 5.9% |
| Insufficient device problem information | 5 | 3.3% | 22% |
| Difficult to insertthe device was hard to insert | 4 | 2.6% | 1.3% |
| Disassembly | 4 | 2.6% | 1.4% |
| Naturally worn | 3 | 2% | 4.3% |
| Breakthe device broke | 2 | 1.3% | 2.8% |
| Off-label use | 2 | 1.3% | 0.2% |
| Crackthe device cracked | 1 | 0.7% | 0.1% |
| Device damaged by another device | 1 | 0.7% | 0% |
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 |
|---|---|---|
| Joint dislocationa dislocated joint | 34 | 22.4% |
| Joint laxity | 4 | 2.6% |
| Painpain, site not specified | 4 | 2.6% |
| Foreign body reaction | 2 | 1.3% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 1.3% |
| Joint disorder | 2 | 1.3% |
| Not applicable | 2 | 1.3% |
| Erythemaskin redness | 1 | 0.7% |
| Falla fall | 1 | 0.7% |
| Fatiguetiredness | 1 | 0.7% |
| Inflammationinflammation | 1 | 0.7% |
| Itching sensation | 1 | 0.7% |
| Numbnessnumbness | 1 | 0.7% |
| Tissue damage | 1 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Pinn Lnr Con +4 Neut 28idx50od | Product code KWZ | All MAUDE reports |
|---|---|---|---|
| Reports | 152 | 5,692 | 26,136,888 |
| Share of that pool | — | 2.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 4 | 9 |
| Classified as injury | 88.8% | 89.7% | 36.2% |
| Classified as malfunction | 11.2% | 9.3% | 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 KWZ
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Hip Acetabular Liners | 4,814 | 260 | 0.2% |
| Unknown Zimmer Hip | 516 | 0 | 0.2% |
| Fmp Hip | 574 | 0 | 0% |
| Srom Stm St 36+8l Nk 18x13x160 | 660 | 1 | 0% |
| Reflection | 359 | 0 | 0% |
| Unk Liner | 373 | 121 | 0% |
| Summit Por Taper Sz5 Std Off | 472 | 1 | 0.2% |
| Summit Por Taper Sz6 Std Off | 459 | 4 | 0.4% |
| Unknown liner | 2,255 | 75 | 0.4% |
| Unknown Depuy Liner | 1,173 | 0 | 0% |
| Unknown Femoral Stem | 237 | 10 | 1.3% |
| Arcos 3 5mm Hex Drive | 152 | 12 | 0% |
| Plus | 276 | 0 | 0.4% |
| Unknown Cup | 1,461 | 66 | 0.4% |
| Articul/Eze Ball 32 +9 Bl | 332 | 4 | 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 Pinn Lnr Con +4 Neut 28idx50od reports
How many FDA reports name Pinn Lnr Con +4 Neut 28idx50od?
152 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 7 in the latest 12 months.
What kinds of events are reported?
injury (88.8%) and malfunction (11.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (32.2%), fracture (3.9%), insufficient device problem information (3.3%), difficult to insert (2.6%) and disassembly (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 Pinn Lnr Con +4 Neut 28idx50od 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.