FDA Adverse Event
Other
Summary report: N
LIMA HIP
MDR report key: 1981279
·
Received February 2, 2011
Report
- Report Number
- 1644408-2011-00053
- Event Type
- Other
- Date Received
- February 2, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 19, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY - THE PT HAD AN INFECTION. THE DOCTOR REMOVED ALL IMPLANTS AND PLACED IN A FULL LIMA HIP SYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIMA HIP | REVISION DISTAL STEM | JDI | ENCORE MEDICAL, L.P. | 1003773 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention | (B)(4), LOT 631C1011| (B)(4), LOT 53877370| (B)(4), LOT 1005533| (B)(4), LOT 53919653 |