FDA Adverse Event
Injury
Summary report: N
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7
MDR report key: 2901626
·
Received January 3, 2013
Report
- Report Number
- 2249697-2013-90002
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K071082
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT PT COMPLAINED OF HIP PAIN. DR REVISED TO BIOMET CUP AND STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2600 | REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | MKAKN7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other| R |