FDA Adverse Event Injury Summary report: N

UNKNOWN_RECONSTRUCTIVE_PRODUCT

MDR report key: 4843909 · Received June 15, 2015

Report

Report Number
0002249697-2015-01925
Event Type
Injury
Date Received
June 15, 2015
Date of Event
May 18, 2015
Report Date
May 18, 2015
Manufacturer
STRYKER ORTHOPAEDICS-MAHWAH
Product Code
KWA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN RIGHT STRYKER HIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER.

Description of Event or Problem · 1

PATIENT'S RIGHT HIP WAS REVISED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
387572 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWA STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 80 YR Required Intervention