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 |