FDA Adverse Event
Injury
Summary report: N
DURACON MEDIUM 2 BASEPLATE
MDR report key: 2915564
·
Received January 10, 2013
Report
- Report Number
- 2249697-2013-90090
- Event Type
- Injury
- Date Received
- January 10, 2013
- Date of Event
- December 18, 2012
- Report Date
- December 18, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LZO
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DURACON MEDIUM 2 CRUCTIX BASEPLATE BECAME LOOSE AND THE DURACON MEDIUM 11 MM INSERT AP-LIPPED INSERT WAS CRACKED. THE SURGEON THEN IMPLANTED A UNIVERSAL DURACON MEDIUM 2 BASEPLATE WITH AN 80 MM CEMENTED STEM EXTENSION. THEN A DURACON MEDIUM 16MM CS INSERT WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 13474 | DURACON MEDIUM 2 BASEPLATE | IMPLANT | LZO | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |