Reported Reactions

Devices › Screw, fixation, bone

Device brand name · Hip other implant

Unknown Depuy Screw: medical device reports filed with FDA

194 reports name it, 2006–2017. Manufacturer given most often on reports: Depuy Orthopaedics. Product code HWC.

194
device reports naming the brand
0% of all MAUDE reports · about 10 a year
0
reports, 12 months to August 2026
0 in the 12 months before
2.6%
classified as malfunction
30.8% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

194 medical device reports received by FDA name the brand "Unknown Depuy Screw" (hip other implant); the manufacturer given most often on reports is Depuy Orthopaedics; received from March 2006 to November 2017. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

0 reports arrived in the 12 months to August 2026, and none 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 (97.4%) and malfunction (2.6%); across all screw, fixation, bone reports (product code HWC) death is recorded in 0.1% and malfunction in 30.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are implant, removal of (30.4%), loss of osseointegration (20.6%) and insufficient device problem information (20.1%). The patient problems coded most often are pain, osteolysis and surgery, prolonged. 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

No report naming Unknown Depuy Screw was received in the five years to August 2026; the latest was received in November 2017.

By year received

018352006: 720062007: 152008: 3520082009: 212010: 1120102011: 122012: 1420122013: 142014: 1720142015: 232016: 1320162017: 12

Event type and report source

Event type, as classified on the report

Death0%0
Injury97.4%189
Malfunction2.6%5
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%194
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 58,946 reports carrying product code HWC. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Implant, removal of5930.4%0.7%
Loss of osseointegration4020.6%0.5%
Insufficient device problem information3920.1%4.3%
Loose2512.9%0.5%
Breakthe device broke168.2%26.4%
Fracturea broken bone94.6%4.2%
Malfunction84.1%0.1%
Migration or expulsion of device84.1%2.1%
Other (for use when an appropriate device code cannot be identified)84.1%0.2%
Device remains implanted42.1%0.6%
Disassembly42.1%0%
Displacement31.5%0.1%
Loss of or failure to bond31.5%0.1%
Malposition of device31.5%0.5%
Osseointegration problem31.5%0.1%
Component(s), broken21%0.4%
Device dislodged or dislocated10.5%1.8%
Device operates differently than expectedthe device behaved unexpectedly10.5%1.8%
Difficult to advance10.5%0.4%
Fitting problem10.5%0.4%

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 specified6131.4%
Osteolysis94.6%
Surgery, prolonged63.1%
Inflammationinflammation52.6%
Surgical procedure, repeated42.1%
Device embedded in tissue or plaque31.5%
Host-tissue reaction31.5%
Inadequate osseointegration31.5%
Ambulation or postural difficulties21%
Bone fracture(s)21%
Foreign body reaction21%
Hematomaa collection of blood under the skin or in tissue21%
Discomfortdiscomfort10.5%
Foreign body, removal of10.5%
Irritationirritation10.5%

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

In context

MeasureUnknown Depuy ScrewProduct code HWCAll MAUDE reports
Reports19458,94626,136,888
Share of that pool—0.3%0%
Classified as death, per 1,000 reports019
Classified as injury97.4%67.2%36.2%
Classified as malfunction2.6%30.8%62.3%
Filed by the manufacturer100%97.3%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 HWC

BrandReportsLatest 12 monthsClassified as death
UNK - Screws: Trauma3,5762880%
UNK - Screws: Locking2,331980%
Unk - Screws Cortex889160%
Unknown Screw1,2221560%
Screw64700%
UNK - Screws: Nail Distal Locking444120.2%
Unknown Screws652231.7%
UNK - Screws: CMF4102800%
UNK - Screws: Locking: Trauma276340%
Unk - Screws 3 5 Mm Cortex220330%
Unk - Screws Nail Locking211190%
UNK - Screws: 2.7 mm VA Locking204220%
Unk - Screws Cannulated19090.5%
Unk - Screws25600%
Locking Screw24130%

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 Unknown Depuy Screw reports

How many FDA reports name Unknown Depuy Screw?

194 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (97.4%) and malfunction (2.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

implant, removal of (30.4%), loss of osseointegration (20.6%), insufficient device problem information (20.1%), loose (12.9%) and break (8.2%). 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 Unknown Depuy 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.