Reported Reactions

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

Device brand name · Ceramic femoral head

UNK Hip Femoral Head Ceramic: medical device reports filed with FDA

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

720
device reports naming the brand
0% of all MAUDE reports · about 120 a year
126
reports, 12 months to August 2026
129 in the 12 months before
1%
classified as malfunction
7.5% across the product code
0.1%
classified as death, as reported
1 reports · not verified by FDA

720 medical device reports received by FDA name the brand "UNK Hip Femoral Head Ceramic" (ceramic femoral head); the manufacturer given most often on reports is Depuy Orthopaedics US; received from July 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

126 reports arrived in the 12 months to August 2026, close to the 129 of 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 (1%) and death (0.1%); 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 device dislodged or dislocated (28.6%), naturally worn (5.1%) and noise, audible (3.2%). 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

01020Sep 2021: 13Oct 2021: 16Nov 2021: 13Dec 2021: 162022Jan 2022: 6Feb 2022: 5Mar 2022: 13Apr 2022: 10May 2022: 9Jun 2022: 9Jul 2022: 15Aug 2022: 5Sep 2022: 12Oct 2022: 12Nov 2022: 16Dec 2022: 92023Jan 2023: 10Feb 2023: 5Mar 2023: 10Apr 2023: 2May 2023: 10Jun 2023: 13Jul 2023: 10Aug 2023: 10Sep 2023: 12Oct 2023: 10Nov 2023: 7Dec 2023: 92024Jan 2024: 3Feb 2024: 6Mar 2024: 14Apr 2024: 15May 2024: 20Jun 2024: 16Jul 2024: 6Aug 2024: 7Sep 2024: 13Oct 2024: 15Nov 2024: 9Dec 2024: 92025Jan 2025: 14Feb 2025: 6Mar 2025: 7Apr 2025: 10May 2025: 11Jun 2025: 14Jul 2025: 12Aug 2025: 9Sep 2025: 15Oct 2025: 10Nov 2025: 17Dec 2025: 122026Jan 2026: 9Feb 2026: 11Mar 2026: 11Apr 2026: 14May 2026: 5Jun 2026: 9Jul 2026: 8Aug 2026: 5

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

0691372020: 1220202021: 13720212022: 12120222023: 10820232024: 13320242025: 13720252026: 722026

Event type and report source

Event type, as classified on the report

Death0.1%1
Injury98.9%712
Malfunction1%7
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%720
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 dislocated20628.6%17%
Naturally worn375.1%6.1%
Noise, audible233.2%1.4%
Fracturea broken bone172.4%4.4%
Degraded30.4%1.7%
Illegible information10.1%0%
Improper or incorrect procedure or method10.1%0.1%

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 joint20428.3%
Painpain, site not specified17424.2%
Joint laxity12417.2%
Appropriate clinical signs, symptoms and conditions term/code not available304.2%
Foreign body reaction263.6%
Falla fall212.9%
Physical asymmetry162.2%
Ambulation or postural difficulties131.8%
Swelling/ edema91.3%
Hypersensitivity/allergic reaction81.1%
Extraskeletal ossification71%
Thrombosis/thrombus71%
Osteolysis50.7%
Discomfortdiscomfort40.6%
Erythemaskin redness40.6%

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

In context

MeasureUNK Hip Femoral Head CeramicProduct code LPHAll MAUDE reports
Reports72090,25126,136,888
Share of that pool—0.8%0%
Classified as death, per 1,000 reports129
Classified as injury98.9%91.7%36.2%
Classified as malfunction1%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%
Unknown Hip2,30651.9%
Trident 0 X3 Insert 36mm Id58500.2%
Altrx Neut 36idx54od553230%
Altrx Neut 32idx50od552210%
Altrx +4 10d 36idx52od544170.2%
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 UNK Hip Femoral Head Ceramic reports

How many FDA reports name UNK Hip Femoral Head Ceramic?

720 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 126 in the latest 12 months.

What kinds of events are reported?

injury (98.9%), malfunction (1%) and death (0.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

device dislodged or dislocated (28.6%), naturally worn (5.1%), noise, audible (3.2%), fracture (2.4%) and degraded (0.4%). 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 Femoral Head Ceramic 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.