FDA Adverse Event
Injury
Summary report: N
UNKNOWN RIGHT HIP STEM
MDR report key: 2860099
·
Received December 4, 2012
Report
- Report Number
- 2249697-2012-02516
- Event Type
- Injury
- Date Received
- December 4, 2012
- Date of Event
- October 1, 2010
- Report Date
- November 19, 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
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING SOME SORENESS. DURING EARLY (B)(6) PATIENT HAD BLOOD WORK DONE. THE BLOOD WORK RESULTS SHOW ELEVATED COBALT LEVELS. PATIENT ALSO STATES THAT HE HAD AN MRI DONE IN EARLY (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN RIGHT HIP STEM | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other |