FDA Adverse Event
Other
Summary report: N
X-ALT HIP
MDR report key: 2163615
·
Received June 8, 2011
Report
- Report Number
- 1644408-2011-00326
- Event Type
- Other
- Date Received
- June 8, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 1, 2011
- Manufacturer
- ENCORE MEDICAL, L.P.
- Product Code
- LPH
- PMA / PMN Number
- K072154
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE LINER DID NOT SECURELY LOCK IN WITH THE 60MM MP10 SHELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | X-ALT HIP | LINER/10 DEGREE HOODED - NEUTRAL | LPH | ENCORE MEDICAL, L.P. | 53957746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |