FDA Adverse Event
Injury
Summary report: N
REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8
MDR report key: 2850863
·
Received November 20, 2012
Report
- Report Number
- 2249697-2012-02398
- Event Type
- Injury
- Date Received
- November 20, 2012
- Date of Event
- October 29, 2012
- Report Date
- October 29, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K092561
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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 THE PT IS HURTING AND HAS HIGHER METAL ION LEVELS AND WANTS THE PROSTHESIS REMOVED AND A NEW ONE PUT IN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | MNR751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other| R |