FDA Adverse Event
Injury
Summary report: N
28MM STD V40 TAPER VIT HEAD
MDR report key: 1113182
·
Received August 12, 2008
Report
- Report Number
- 9616680-2008-00239
- Event Type
- Injury
- Date Received
- August 12, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 24, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- KWY
- PMA / PMN Number
- K022077
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
NI
Description of Event or Problem · 1
IT WAS REPORTED FROM THE COVENANT HEALTHCARE EMERGENCY CARE CENTER REPORT DATED 2006, IT APPEARS THAT THE PATIENT WAS BROUGHT VIA AMBULANCE TO THE EMERGENCY ROOM WITH A DISLOCATED RIGHT HIP. ATTEMPT AT CLOSED REDUCTION WAS UNSUCCESSFUL AND THE PATIENT WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 28MM STD V40 TAPER VIT HEAD | IMPLANT | KWY | STRYKER ORTHOPAEDICS CORK | NA | 17636701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |