Reported Reactions

Devices › Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented

Device brand name · Pinnacle hip system hip poly acetabular liners

Altrx +4 Neut 32idx48od: medical device reports filed with FDA

232 reports name it, 2008–2025. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code LPH.

232
device reports naming the brand
0% of all MAUDE reports · about 13 a year
3
reports, 12 months to August 2026
14 in the 12 months before
1.3%
classified as malfunction
7.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

232 medical device reports received by FDA name the brand "Altrx +4 Neut 32idx48od" (pinnacle hip system hip poly acetabular liners); the manufacturer given most often on reports is Depuy Orthopaedics US; received from September 2008 to November 2025. 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 79% from 14 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 (98.7%) and malfunction (1.3%); across all prosthesis, hip, semi-constrained, metal/polymer, porous uncemented reports (product code LPH) death is recorded in 0.2% and malfunction in 7.5%. 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 (46.1%), insufficient device problem information (12.9%) and fracture (6.5%). The patient problems coded most often are joint dislocation, pain and joint laxity. 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

024Sep 2021: 2Oct 2021: 1Nov 2021: 2Dec 2021: 32022Jan 2022: 0Feb 2022: 0Mar 2022: 1Apr 2022: 3May 2022: 4Jun 2022: 2Jul 2022: 2Aug 2022: 2Sep 2022: 0Oct 2022: 2Nov 2022: 1Dec 2022: 12023Jan 2023: 2Feb 2023: 0Mar 2023: 3Apr 2023: 0May 2023: 3Jun 2023: 1Jul 2023: 0Aug 2023: 2Sep 2023: 2Oct 2023: 1Nov 2023: 1Dec 2023: 32024Jan 2024: 2Feb 2024: 3Mar 2024: 4Apr 2024: 0May 2024: 1Jun 2024: 3Jul 2024: 1Aug 2024: 1Sep 2024: 0Oct 2024: 2Nov 2024: 0Dec 2024: 02025Jan 2025: 1Feb 2025: 2Mar 2025: 0Apr 2025: 2May 2025: 2Jun 2025: 2Jul 2025: 2Aug 2025: 1Sep 2025: 0Oct 2025: 2Nov 2025: 1Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

010202008: 320082009: 62010: 720102011: 42012: 520122013: 112014: 1920142015: 202016: 1920162017: 152018: 1220182019: 162020: 1420202021: 132022: 1820222023: 182024: 1720242025: 15

Event type and report source

Event type, as classified on the report

Death0%0
Injury98.7%229
Malfunction1.3%3
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%232
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 90,251 reports carrying product code LPH. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Device dislodged or dislocated10746.1%17%
Insufficient device problem information3012.9%19.2%
Fracturea broken bone156.5%4.4%
Naturally worn114.7%6.1%
Disassembly93.9%1.4%
Breakthe device broke41.7%1.6%
Noise, audible31.3%1.4%
Difficult to insertthe device was hard to insert20.9%1.2%
Material separation20.9%0.2%
Loss of or failure to bond10.4%0.8%
Loss of osseointegration10.4%4.5%
Malposition of device10.4%2.3%
Material disintegration10.4%0.3%

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
Joint dislocationa dislocated joint7532.3%
Painpain, site not specified2912.5%
Joint laxity166.9%
Not applicable62.6%
Falla fall52.2%
Foreign body reaction52.2%
Discomfortdiscomfort41.7%
Joint disorder31.3%
Swelling/ edema31.3%
Ambulation or postural difficulties20.9%
Embolism/embolus20.9%
Host-tissue reaction20.9%
Inflammationinflammation20.9%
Loss of range of motion20.9%
Osteolysis20.9%

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

In context

MeasureAltrx +4 Neut 32idx48odProduct code LPHAll MAUDE reports
Reports23290,25126,136,888
Share of that pool—0.3%0%
Classified as death, per 1,000 reports029
Classified as injury98.7%91.7%36.2%
Classified as malfunction1.3%7.5%62.3%
Filed by the manufacturer100%99.1%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 LPH

BrandReportsLatest 12 monthsClassified as death
Unknown Hip Acetabular Liners4,8142600.2%
Unknown Hip Acetabular Cup3,2151060.4%
Apex Hole Elim Positive Stop1,082200.4%
Pinn Can Bone Screw 6 5mmx25mm1,299320%
Unknown Hip Femoral Stem4,140790.8%
Unknown Hip Femoral Head5,0801760.7%
Pinn Can Bone Screw 6 5mmx20mm1,075190.3%
Pinn Can Bone Screw 6 5mmx30mm981220.3%
Altrx Neut 36idx52od638230%
UNK Hip Femoral Head Ceramic7201260.1%
Unknown Hip2,30651.9%
Trident 0 X3 Insert 36mm Id58500.2%
Altrx Neut 36idx54od553230%
Altrx Neut 32idx50od552210%
Altrx +4 10d 36idx52od544170.2%

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 Altrx +4 Neut 32idx48od reports

How many FDA reports name Altrx +4 Neut 32idx48od?

232 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 (98.7%) and malfunction (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device dislodged or dislocated (46.1%), insufficient device problem information (12.9%), fracture (6.5%), naturally worn (4.7%) and disassembly (3.9%). 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 Altrx +4 Neut 32idx48od 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.