FDA Adverse Event
Injury
Summary report: N
VANGUARD PS TIBIAL TRIAL POST
MDR report key: 1894500
·
Received November 9, 2010
Report
- Report Number
- 1825034-2010-00510
- Event Type
- Injury
- Date Received
- November 9, 2010
- Date of Event
- October 9, 2010
- Report Date
- October 12, 2010
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- IQO
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER INFORMATION NEEDED TO REVIEW DEVICE HISTORY RECORDS WAS UNAVAILABLE. THIS REPORT SUBMITTED (B)(6) 2010.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, AT ONE MONTH POST-OPERATIVE RADIOGRAPHS, SURGEON NOTED THAT THE TIBIAL TRIAL POST WAS IMPLANTED WITHIN THE PATIENT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2010, TO REMOVE THE TRIAL POST.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2010. SUBSEQUENTLY, AT ONE MONTH POST-OPERATIVE RADIOGRAPHS, SURGEON NOTED THAT THE TIBIAL TRIAL POST WAS IMPLANTED WITHIN THE PATIENT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2010, TO REMOVE THE TRIAL POST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VANGUARD PS TIBIAL TRIAL POST | DEVICE, PROSTHESIS, ALIGNMENT | IQO | BIOMET ORTHOPEDICS | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| R |