FDA Adverse Event
Injury
Summary report: N
DURA DURATION A/P TIB LG 9
MDR report key: 4102956
·
Received September 19, 2014
Report
- Report Number
- 0002249697-2014-03568
- Event Type
- Injury
- Date Received
- September 19, 2014
- Date of Event
- May 1, 2006
- Report Date
- August 25, 2014
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MBH
- PMA / PMN Number
- K032163
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LOT CODE PROVIDED, 61213Y. IS INVALID. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT HAD POLY SWAP DUE TO INSTABILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584976 | DURA DURATION A/P TIB LG 9 | IMPLANT | MBH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Hospitalization| R |