FDA Adverse Event
Injury
Summary report: N
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9
MDR report key: 2171352
·
Received July 18, 2011
Report
- Report Number
- 2249697-2011-01076
- Event Type
- Injury
- Date Received
- July 18, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 23, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K071082
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
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, "REVISION OF REJUVENATE HIP."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 9 | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | 3R2MRD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |