FDA Adverse Event
Injury
Summary report: N
UHR BIPOLAR 28X46MM
MDR report key: 2162187
·
Received July 7, 2011
Report
- Report Number
- 2249697-2011-01020
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- June 17, 2011
- Report Date
- June 17, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- KWL
- PMA / PMN Number
- K800207
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATALOG NUMBER AND LOT CODE OF OTHER DEVICE LISTED IN THIS REPORT: CAT # 06-2898, LOT# MJMD2E, DESCRIPTION: C-TAPER COCR LFIT HEAD 28MM/3. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "INFECTION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UHR BIPOLAR 28X46MM | IMPLANT | KWL | STRYKER ORTHOPAEDICS MAHWAH | NA | MJL07N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other| R |