Reported Reactions

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

Device brand name · Pinnacle hip system hip poly acetabular liners

Altrx +4 10d 36idx52od: medical device reports filed with FDA

544 reports name it, 2010–2026. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code LPH.

544
device reports naming the brand
0% of all MAUDE reports · about 33 a year
17
reports, 12 months to August 2026
27 in the 12 months before
0.9%
classified as malfunction
7.5% across the product code
0.2%
classified as death, as reported
1 reports · not verified by FDA

544 medical device reports received by FDA name the brand "Altrx +4 10d 36idx52od" (pinnacle hip system hip poly acetabular liners); the manufacturer given most often on reports is Depuy Orthopaedics US; received from February 2010 to May 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

17 reports arrived in the 12 months to August 2026, down 37% from 27 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 (98.9%), malfunction (0.9%) and death (0.2%); 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 (55.9%), insufficient device problem information (16.2%) and fracture (5.3%). 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

036Sep 2021: 1Oct 2021: 0Nov 2021: 2Dec 2021: 22022Jan 2022: 4Feb 2022: 2Mar 2022: 3Apr 2022: 1May 2022: 0Jun 2022: 2Jul 2022: 0Aug 2022: 1Sep 2022: 2Oct 2022: 4Nov 2022: 2Dec 2022: 62023Jan 2023: 2Feb 2023: 2Mar 2023: 2Apr 2023: 0May 2023: 4Jun 2023: 2Jul 2023: 2Aug 2023: 3Sep 2023: 3Oct 2023: 2Nov 2023: 2Dec 2023: 22024Jan 2024: 3Feb 2024: 5Mar 2024: 5Apr 2024: 2May 2024: 2Jun 2024: 1Jul 2024: 2Aug 2024: 0Sep 2024: 2Oct 2024: 3Nov 2024: 3Dec 2024: 12025Jan 2025: 2Feb 2025: 0Mar 2025: 2Apr 2025: 5May 2025: 3Jun 2025: 1Jul 2025: 3Aug 2025: 2Sep 2025: 3Oct 2025: 3Nov 2025: 2Dec 2025: 42026Jan 2026: 2Feb 2026: 2Mar 2026: 0Apr 2026: 0May 2026: 1Jun 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

040792010: 1220102011: 332012: 2720122013: 322014: 3320142015: 422016: 4020162017: 342018: 3920182019: 792020: 2720202021: 292022: 2720222023: 262024: 2920242025: 302026: 52026

Event type and report source

Event type, as classified on the report

Death0.2%1
Injury98.9%538
Malfunction0.9%5
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%544
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 dislocated30455.9%17%
Insufficient device problem information8816.2%19.2%
Fracturea broken bone295.3%4.4%
Naturally worn264.8%6.1%
Disassembly203.7%1.4%
Noise, audible71.3%1.4%
Breakthe device broke61.1%1.6%
Loss of osseointegration20.4%4.5%
Material deformation20.4%0.5%
Component incompatible10.2%0%
Crackthe device cracked10.2%0.1%
Difficult to insertthe device was hard to insert10.2%1.2%
Disconnection10.2%0%
Inadequacy of device shape and/or size10.2%0.3%
Malposition of device10.2%2.3%
Material separation10.2%0.2%
Metal shedding debris10.2%1.3%
Off-label use10.2%0.1%
Unstable10.2%1.1%

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 joint16630.5%
Painpain, site not specified8515.6%
Joint laxity254.6%
Appropriate clinical signs, symptoms and conditions term/code not available173.1%
Falla fall122.2%
Foreign body reaction122.2%
Tissue damage112%
Ambulation or postural difficulties91.7%
Not applicable91.7%
Discomfortdiscomfort81.5%
Host-tissue reaction61.1%
Inflammationinflammation61.1%
Joint disorder50.9%
Limited mobility of the implanted joint40.7%
Osteolysis40.7%

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

In context

MeasureAltrx +4 10d 36idx52odProduct code LPHAll MAUDE reports
Reports54490,25126,136,888
Share of that pool—0.6%0%
Classified as death, per 1,000 reports229
Classified as injury98.9%91.7%36.2%
Classified as malfunction0.9%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 Neut 36idx52od521170%

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 10d 36idx52od reports

How many FDA reports name Altrx +4 10d 36idx52od?

544 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 17 in the latest 12 months.

What kinds of events are reported?

injury (98.9%), malfunction (0.9%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device dislodged or dislocated (55.9%), insufficient device problem information (16.2%), fracture (5.3%), naturally worn (4.8%) and disassembly (3.7%). 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 10d 36idx52od 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.