Reported Reactions

Devices › Prosthesis, hip, semi-constrained, metal/polymer, cemented

Device brand name · Hip prosthesis

Unknown Zimmer Hip: medical device reports filed with FDA

516 reports name it, 2008–2017. Manufacturer given most often on reports: Zimmer. Product code JDI.

516
device reports naming the brand
0% of all MAUDE reports · about 28 a year
0
reports, 12 months to August 2026
0 in the 12 months before
6.4%
classified as malfunction
7.8% across the product code
0.2%
classified as death, as reported
1 reports · not verified by FDA

516 medical device reports received by FDA name the brand "Unknown Zimmer Hip" (hip prosthesis); the manufacturer given most often on reports is Zimmer; received from April 2008 to February 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 (93.4%), malfunction (6.4%) and death (0.2%); across all prosthesis, hip, semi-constrained, metal/polymer, cemented reports (product code JDI) death is recorded in 0.4% and malfunction in 7.8%. 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 (52.3%), device dislodged or dislocated (11%) and device remains implanted (9.1%). The patient problems coded most often are pain, surgical procedure, repeated and foreign body reaction. 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 Zimmer Hip was received in the five years to August 2026; the latest was received in February 2017.

By year received

0581152008: 720082009: 420092010: 5420102011: 11520112012: 7520122013: 6620132014: 5920142015: 5520152016: 7620162017: 52017

Event type and report source

Event type, as classified on the report

Death0.2%1
Injury93.4%482
Malfunction6.4%33
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%516
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 70,618 reports carrying product code JDI. 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 information27052.3%30.7%
Device dislodged or dislocated5711%14.7%
Device remains implanted479.1%0.4%
Explanted275.2%4%
Implant, removal of244.7%3.8%
Dislocated203.9%2.2%
Corrodedthe device corroded132.5%2.9%
Loose91.7%1.4%
Failure to adhere or bond81.6%0.1%
Detachment of device component61.2%0.3%
Fracturea broken bone51%3.7%
Migration or expulsion of device30.6%0.9%
Breakthe device broke20.4%2.7%
Device operates differently than expectedthe device behaved unexpectedly20.4%1.2%
Loose or intermittent connection20.4%1%
Malposition of device20.4%1%
Material erosion20.4%1.1%
Noise20.4%0.1%
Unstable20.4%1.1%
Biocompatibility10.2%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 specified24848.1%
Surgical procedure, repeated509.7%
Foreign body reaction244.7%
Joint dislocationa dislocated joint224.3%
Bone fracture(s)61.2%
Other (for use when an appropriate patient code cannot be identified)61.2%
Reactiona reaction, type not specified61.2%
Swellingswelling61.2%
Falla fall51%
Osteolysis51%
Joint swellinga swollen joint40.8%
Limited mobility of the implanted joint40.8%
Hospitalization required30.6%
Surgical procedure, additional30.6%
Ambulation or postural difficulties20.4%

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

In context

MeasureUnknown Zimmer HipProduct code JDIAll MAUDE reports
Reports51670,61826,136,888
Share of that pool—0.7%0%
Classified as death, per 1,000 reports249
Classified as injury93.4%91.3%36.2%
Classified as malfunction6.4%7.8%62.3%
Filed by the manufacturer100%98.4%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 JDI

BrandReportsLatest 12 monthsClassified as death
Articuleze M Head 36mm +1 53,431240.1%
Articuleze M Head 36mm +53,111240.1%
Unknown Hip Femoral Head5,0801760.7%
Articuleze M Head 36mm -21,661100.2%
Articuleze M Head 36mm +8 51,674110.1%
Unknown Hip Femoral Stem4,140790.8%
Unknown Hip2,30651.9%
Unknown Head2,2501030.7%
Unknown Stem1,857840.5%
Unknown liner2,255750.4%
Unknown Reconstructive Product2,57900.4%
Articul/Eze Ball 32 +1 Gr69550.1%
UNK Hip Femoral Head Metal728670.1%
Articul/Eze Ball 28 +1 5 Gr641200.3%
S-Rom M Head 36mm +082700%

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 Zimmer Hip reports

How many FDA reports name Unknown Zimmer Hip?

516 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 (93.4%), malfunction (6.4%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

insufficient device problem information (52.3%), device dislodged or dislocated (11%), device remains implanted (9.1%), explanted (5.2%) and implant, removal of (4.7%). 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 Unknown Zimmer Hip 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.