FDA Adverse Event
Injury
Summary report: N
TRITANIUM REVISION ACETABULAR
MDR report key: 2012915
·
Received March 1, 2011
Report
- Report Number
- 2249697-2011-00229
- Event Type
- Injury
- Date Received
- March 1, 2011
- Date of Event
- August 19, 2008
- Report Date
- February 3, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K010170
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION PROVIDED BY STRYKER (B)(4). NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. ADDITIONAL F/U INFORMATION MAY BE OBTAINED BY THE CLINICAL AFFAIRS AS IT BECOMES AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
DURING A SITE CLOSE-OUT VISIT AT THE (B)(6) HOSPITAL, THE CRA CONDUCTING THE VISIT NOTED AN AE FOR REVISION OF THE STRYKER STUDY COMPONENTS. THE COMPONENTS WERE REPORTED TO BE REVISED FOR COMPONENT LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRITANIUM REVISION ACETABULAR | IMPLANT | LPH | STRYKER ORTHOPAEDICS MAHWAH | NA | 8H9MDE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other| R |