FDA Adverse Event
Injury
Summary report: N
LRG TAP PRI MOD NCK 0DEG 30MM
MDR report key: 2930479
·
Received January 22, 2013
Report
- Report Number
- 9616680-2013-90152
- Event Type
- Injury
- Date Received
- January 22, 2013
- Date of Event
- May 17, 2011
- Report Date
- October 19, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K092561
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
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 IS REPORTED THAT THE PT WAS NOTIFIED OF THE RECALL BY HER DOCTOR. SHE REPORTS THAT SHE IS NOT EXPERIENCING PAIN OR SWELLING. SHE RECENTLY HAD BLOOD TEST WHICH HAD METAL LEVELS ABOVE 6.0 AND AN MRI WHICH SHOWED NO ABNORMALITIES. HER SURGEON WILL MONITOR HER WITH BLOOD TESTING EVERY THREE MONTHS. INFORMATION RECEIVED ON (B)(6) 2013 DR (B)(6) STATES PT PRESENTED WITH INCREASED PAIN IN JOINT AREA, ELEVATED CHROME AND COBALT SERUM LEVELS, POSITIVE MARS SCAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30765 | LRG TAP PRI MOD NCK 0DEG 30MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 35419201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |