FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 0DEG 30MM
MDR report key: 2901627
·
Received January 3, 2013
Report
- Report Number
- 9616680-2013-90002
- Event Type
- Injury
- Date Received
- January 3, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- K071082
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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 THE SURGEON REVISED PATIENT'S RIGHT REJUVENATE HIP DUE TO PAIN AND MRI SHOWED PSEUDO TUMOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3159 | LRG TAP PRI MOD NCK 0DEG 30MM | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | 23282604 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other| R |