FDA Adverse Event
Injury
Summary report: N
PERSONA CR FEMORAL COMPONENT
MDR report key: 4112877
·
Received September 17, 2014
Report
- Report Number
- 3007963827-2014-00043
- Event Type
- Injury
- Date Received
- September 17, 2014
- Date of Event
- August 19, 2014
- Report Date
- August 19, 2014
- Manufacturer
- ZIMMER ORTHOPEDIC MFG LTD
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT WAS NOT ACHIEVING FLEXION GOALS AND UNDERWENT MANIPULATION UNDER ANESTHESIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 576047 | PERSONA CR FEMORAL COMPONENT | JWH | ZIMMER ORTHOPEDIC MFG LTD | 62477593 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other |