FDA Adverse Event
Other
Summary report: N
TRUFIT BGS PLUG
MDR report key: 1264714
·
Received December 12, 2008
Report
- Report Number
- 1651491-2008-00023
- Event Type
- Other
- Date Received
- December 12, 2008
- Date of Event
- February 18, 2005
- Report Date
- March 7, 2005
- Manufacturer
- SMITH & NEPHEW
- Product Code
- MQV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS PART OF OUR RISK MANAGEMENT PROCESS A RETROSPECTIVE REVIEW OF TRUFIT PLUG COMPLAINTS, WHICH WAS PRIOR TO SMITH-NEPHEW INTEGRATION, HAS BEEN CONDUCTED. AS A RESULT THIS COMPLAINT HAS BEEN DETERMINED TO BE REPORTABLE.
Description of Event or Problem · 1
PT WAS OPERATED ON IN 2004; DEFECT IDENTIFIED ON MFC. PT COMPLAINED OF LOCKED KNEE TWO MONTHS LATER. MEDIAL CONDYLE TENDER AND X-RAYS INDICATED A LOOSE BODY TO BE PRESENT. PT OPERATED ON THE FOLLOWING WEEK. RESIDUAL MATERIAL EASILY REMOVED. BLEEDING OF IMPLANT SITE NOTED ONCE MATERIAL REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRUFIT BGS PLUG | TRUFIT | MQV | SMITH & NEPHEW | BGS-040420-03 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Required Intervention |