Reported Reactions

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

Device brand name · Bone screw

UNK Hip Bone Screw: medical device reports filed with FDA

347 reports name it, 2020–2026. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code LPH.

347
device reports naming the brand
0% of all MAUDE reports · about 60 a year
14
reports, 12 months to August 2026
42 in the 12 months before
4%
classified as malfunction
7.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 347 reports that name the brand "UNK Hip Bone Screw" (bone screw), received between September 2020 and August 2026; the manufacturer given most often on reports is Depuy Orthopaedics US. Spellings of one product vary from report to report.

14 reports arrived in the 12 months to August 2026, down 67% from 42 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 (96%) and malfunction (4%); 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 osseointegration problem (29.1%), fracture (4.3%) and difficult to advance (2.9%). The patient problems coded most often are inadequate osseointegration, 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

01020Sep 2021: 20Oct 2021: 10Nov 2021: 7Dec 2021: 32022Jan 2022: 3Feb 2022: 9Mar 2022: 3Apr 2022: 12May 2022: 6Jun 2022: 8Jul 2022: 7Aug 2022: 5Sep 2022: 3Oct 2022: 5Nov 2022: 6Dec 2022: 62023Jan 2023: 8Feb 2023: 2Mar 2023: 10Apr 2023: 10May 2023: 8Jun 2023: 1Jul 2023: 3Aug 2023: 4Sep 2023: 4Oct 2023: 3Nov 2023: 2Dec 2023: 32024Jan 2024: 3Feb 2024: 4Mar 2024: 8Apr 2024: 4May 2024: 6Jun 2024: 6Jul 2024: 10Aug 2024: 1Sep 2024: 3Oct 2024: 7Nov 2024: 3Dec 2024: 12025Jan 2025: 2Feb 2025: 1Mar 2025: 6Apr 2025: 9May 2025: 3Jun 2025: 1Jul 2025: 5Aug 2025: 1Sep 2025: 2Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 5Feb 2026: 2Mar 2026: 0Apr 2026: 3May 2026: 0Jun 2026: 0Jul 2026: 1Aug 2026: 1

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

046922020: 2620202021: 9220212022: 7320222023: 5820232024: 5620242025: 3020252026: 122026

Event type and report source

Event type, as classified on the report

Death0%0
Injury96%333
Malfunction4%14
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%347
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
Osseointegration problem10129.1%2.8%
Fracturea broken bone154.3%4.4%
Difficult to advance102.9%0%
Migrationthe device moved from where it was placed102.9%1%
Noise, audible30.9%1.4%
Improper or incorrect procedure or method20.6%0.1%
Loss of osseointegration20.6%4.5%
Loss of or failure to bond10.3%0.8%

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
Inadequate osseointegration9928.5%
Painpain, site not specified9828.2%
Joint laxity6518.7%
Appropriate clinical signs, symptoms and conditions term/code not available308.6%
Foreign body reaction164.6%
Loss of range of motion92.6%
Bone fracture(s)82.3%
Falla fall82.3%
Necrosisdeath of tissue82.3%
Hypersensitivity/allergic reaction72%
Osteolysis72%
Inflammationinflammation61.7%
Ambulation or postural difficulties51.4%
Fatiguetiredness51.4%
Swelling/ edema51.4%

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

In context

MeasureUNK Hip Bone ScrewProduct code LPHAll MAUDE reports
Reports34790,25126,136,888
Share of that pool—0.4%0%
Classified as death, per 1,000 reports029
Classified as injury96%91.7%36.2%
Classified as malfunction4%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 UNK Hip Bone Screw reports

How many FDA reports name UNK Hip Bone Screw?

347 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 14 in the latest 12 months.

What kinds of events are reported?

injury (96%) and malfunction (4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

osseointegration problem (29.1%), fracture (4.3%), difficult to advance (2.9%), migration (2.9%) and noise, audible (0.9%). 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 UNK Hip Bone Screw 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.