FDA Adverse Event
Other
Summary report: N
LINEAR HIP
MDR report key: 1981203
·
Received January 26, 2011
Report
- Report Number
- 1644408-2011-00046
- Event Type
- Other
- Date Received
- January 26, 2011
- Date of Event
- January 19, 2011
- Report Date
- January 19, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- LPH
- PMA / PMN Number
- K974294
- 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 PATIENT SUSTAINED A FRACTURE AROUND THE STEM, AS A RESULT, IT SUBSIDED THE STEM. THE DOCTOR REMOVED THE STEM, HEAD AND SLEEVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINEAR HIP | LATERAL OFFSET STEM | LPH | ENCORE MEDICAL, L.P. | 935031A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention | (B)(4), LOT 54037121| (B)(4), LOT 53993332 |