Reported Reactions

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

Device brand name · Bone screws and pins screws

Pinn Can Bone Screw 6 5mmx35mm: medical device reports filed with FDA

586 reports name it, 2006–2026. Manufacturer given most often on reports: Depuy Orthopaedics US. Product code LPH.

586
device reports naming the brand
0% of all MAUDE reports · about 29 a year
21
reports, 12 months to August 2026
30 in the 12 months before
6.1%
classified as malfunction
7.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

586 medical device reports received by FDA name the brand "Pinn Can Bone Screw 6 5mmx35mm" (bone screws and pins screws); the manufacturer given most often on reports is Depuy Orthopaedics US; received from May 2006 to March 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

21 reports arrived in the 12 months to August 2026, down 30% from 30 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 (93.9%) and malfunction (6.1%); 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 insufficient device problem information (23.4%), loss of osseointegration (21.5%) and osseointegration problem (9.2%). The patient problems coded most often are pain, inadequate osseointegration and discomfort. 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: 2Oct 2021: 3Nov 2021: 4Dec 2021: 42022Jan 2022: 0Feb 2022: 1Mar 2022: 1Apr 2022: 4May 2022: 0Jun 2022: 2Jul 2022: 0Aug 2022: 1Sep 2022: 0Oct 2022: 0Nov 2022: 2Dec 2022: 22023Jan 2023: 3Feb 2023: 1Mar 2023: 1Apr 2023: 3May 2023: 1Jun 2023: 2Jul 2023: 4Aug 2023: 4Sep 2023: 2Oct 2023: 1Nov 2023: 2Dec 2023: 22024Jan 2024: 1Feb 2024: 3Mar 2024: 3Apr 2024: 2May 2024: 1Jun 2024: 3Jul 2024: 0Aug 2024: 3Sep 2024: 0Oct 2024: 3Nov 2024: 2Dec 2024: 22025Jan 2025: 6Feb 2025: 2Mar 2025: 2Apr 2025: 1May 2025: 3Jun 2025: 3Jul 2025: 3Aug 2025: 3Sep 2025: 5Oct 2025: 3Nov 2025: 2Dec 2025: 22026Jan 2026: 3Feb 2026: 0Mar 2026: 6Apr 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

044882006: 520062008: 72009: 820092010: 122011: 2020112012: 232013: 4620132014: 402015: 5020152016: 372017: 2220172018: 652019: 8820192020: 292021: 2820212022: 132023: 2620232024: 232025: 3520252026: 9

Event type and report source

Event type, as classified on the report

Death0%0
Injury93.9%550
Malfunction6.1%36
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%586
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
Insufficient device problem information13723.4%19.2%
Loss of osseointegration12621.5%4.5%
Osseointegration problem549.2%2.8%
Fracturea broken bone254.3%4.4%
Loose or intermittent connection233.9%1.1%
Loss of or failure to bond193.2%0.8%
Breakthe device broke132.2%1.6%
Malposition of device91.5%2.3%
Metal shedding debris81.4%1.3%
Device dislodged or dislocated61%17%
Migration or expulsion of device50.9%1%
Failure to osseointegrate40.7%0.2%
Manufacturing, packaging or shipping problem40.7%0.3%
Migrationthe device moved from where it was placed30.5%1%
Noise, audible30.5%1.4%
Difficult to advance20.3%0%
Difficult to open or remove packaging material20.3%0%
Disassembly20.3%1.4%
Naturally worn20.3%6.1%
Component missing10.2%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)ReportsShare
Painpain, site not specified23740.4%
Inadequate osseointegration10117.2%
Discomfortdiscomfort6511.1%
Foreign body reaction467.8%
Inflammationinflammation356%
Host-tissue reaction274.6%
Tissue damage274.6%
Not applicable223.8%
Limited mobility of the implanted joint213.6%
Ambulation or postural difficulties183.1%
Bone fracture(s)172.9%
Hypersensitivity/allergic reaction162.7%
Joint laxity152.6%
Osteolysis142.4%
Injurya physical injury132.2%

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

In context

MeasurePinn Can Bone Screw 6 5mmx35mmProduct code LPHAll MAUDE reports
Reports58690,25126,136,888
Share of that pool—0.6%0%
Classified as death, per 1,000 reports029
Classified as injury93.9%91.7%36.2%
Classified as malfunction6.1%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 Pinn Can Bone Screw 6 5mmx35mm reports

How many FDA reports name Pinn Can Bone Screw 6 5mmx35mm?

586 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 21 in the latest 12 months.

What kinds of events are reported?

injury (93.9%) and malfunction (6.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (23.4%), loss of osseointegration (21.5%), osseointegration problem (9.2%), fracture (4.3%) and loose or intermittent connection (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 Pinn Can Bone Screw 6 5mmx35mm 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.