ELITE 9625-75-000Recalls & reported problems
Depuy (Ireland) · ELITE FEMORAL HEAD +0 9/10 TAPER Diameter 32mm · Class 2 · Implant
All models of ELITE (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295243182), received between Jun 14, 2019 and Jun 14, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation1
- No Code Available1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
PRIMARY SURGERY DATE APPROX 30 YEARS AGO, 1ST REVISION ON (B)(6) 2019 (CAPTURED AS (B)(4)) WITH SUBSEQUENT REVISION AND WASHOUT. SUBSEQUENT TO THE ABOVE, THE PATIENT HAS SEVERAL DISLOCATIONS. TO REMEDY THIS ISSUE, THE PATIENT UNDERWENT A SECOND REVISION WHERE THE BIOMET LINER WAS REMOVED AND EXCHANGED FOR A CAPTIVE LINER. THE DEPUY HEAD WAS LEFT IN SITU. PATIENT HAS THE PRESENTED WITH AN INFECTED HIP, AND HAS UNDERGONE 1 WASHOUT. THIS WAS THE SECOND WASHOUT AND THE SURGEON HAS ELECTED TO EXCHANGE THE CAPTIVE LINER (BIOMET) ALONG WITH THE FEMORAL HEAD (B)(6) 2019.
Patient problems: Joint Dislocation; No Code Available; Unspecified Infection
MAUDE report 8700193 ↗
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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