FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEPUY FEMORAL STEM
MDR report key: 2820566
·
Received November 6, 2012
Report
- Report Number
- 1818910-2012-23989
- Event Type
- Injury
- Date Received
- November 6, 2012
- Date of Event
- February 8, 2011
- Report Date
- May 1, 2026
- Manufacturer
- DEPUY INTERNATIONAL
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP 2 IS BEING SUBMITTED TO FILL THE GAP IN REPORT SEQUENCE NUMBERS.
Additional Manufacturer Narrative · 0
THERE IS NO NEW INFORMATION TO REPORT AT THIS TIME. PER FDA REQUEST, THIS FOLLOW-UP 1 IS BEING SUBMITTED TO FILL THE GAP IN REPORT SEQUENCE NUMBERS.
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
LITIGATION ALLEGES PATIENT HAD PAIN, WEAKNESS, DIFFICULTY WITH DAILY ACTIVITIES, LEG LENGTH INEQUALITY AND INCREASED METALLIC IONS IN THE BLOODSTREAM AFTER ASR HIP IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 568037 | UNKNOWN DEPUY FEMORAL STEM | PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | LPH | DEPUY INTERNATIONAL | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female | Required Intervention |