FDA Adverse Event
Injury
Summary report: N
UNK TIBIAL BASEPLATE
MDR report key: 2911048
·
Received January 4, 2013
Report
- Report Number
- 2249697-2013-90031
- Event Type
- Injury
- Date Received
- January 4, 2013
- Date of Event
- December 12, 2012
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD¿L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SUBJECT WAS ENROLLED INTO THE (B)(4) STUDY AND RECEIVED THEIR STUDY SURGERY. THE EXACT DATE OF SURGERY IS STILL BEING CLARIFIED WITH THE SITE. THE SUBJECT WAS REVISED DUE TO A LOOSE TIBIAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4203 | UNK TIBIAL BASEPLATE | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |