FDA Adverse Event
Injury
Summary report: N
UNKNOWN LEFT STRYKER HIP SYSTEM
MDR report key: 2831117
·
Received November 2, 2012
Report
- Report Number
- 2249697-2012-02146
- Event Type
- Injury
- Date Received
- November 2, 2012
- Date of Event
- December 1, 2011
- Report Date
- October 12, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
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 THE PT IS EXPERIENCING PAIN IN LEFT LEG. PT IS HAVING TROUBLE LYING IN BED. PT IS ALSO EXPERIENCING THROBBING IN TAILBONE. PT STATES THAT THE PAIN IS MORE AGGRESSIVE IN THE RIGHT HIP BUT IS STILL EXPERIENCING PAIN IN THE LEFT HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN LEFT STRYKER HIP SYSTEM | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |