FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 0DEG 38MM
MDR report key: 2850877
·
Received November 20, 2012
Report
- Report Number
- 9616680-2012-01146
- Event Type
- Injury
- Date Received
- November 20, 2012
- Date of Event
- November 6, 2012
- Report Date
- November 6, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K071082
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DOCTOR (B)(6) REVISED THE PTS RIGHT HIP DUE TO ADVERSE LOCAL TISSUE REACTION ALTR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LRG TAP PRI MOD NCK 0DEG 38MM | UNKNOWN | LZO | STRYKER ORTHOPAEDICS CORK | NA | 29683401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |