FDA Adverse Event Injury Summary report: N

UNKNOWN_RECONSTRUCTIVE_PRODUCT

MDR report key: 4221687 · Received November 3, 2014

Report

Report Number
0002249697-2014-04119
Event Type
Injury
Date Received
November 3, 2014
Date of Event
October 8, 2014
Report Date
October 8, 2014
Manufacturer
STRYKER ORTHOPAEDICS-MAHWAH
Product Code
KWY
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
MA, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

CATALOG NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN STRYKER HIP. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DUE TO ONGOING LITIGATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED.

Description of Event or Problem · 1

IT WAS REPORTED PATIENT SUFFERED PAIN AND IS REQUESTING MONETARY COMPENSATION FOR PAIN AND SUFFERING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
702382 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT KWY STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 79 YR Other