FDA Adverse Event
Other
Summary report: N
TC-PLUS SB SOLUTION
MDR report key: 570802
·
Received January 14, 2005
Report
- Report Number
- 2086141-2005-00001
- Event Type
- Other
- Date Received
- January 14, 2005
- Report Date
- December 16, 2004
- Manufacturer
- PLUS ORTHOPEDICS AG
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NY, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
PLUS ORTHOPEDICS USA WAS INFORMED IN 2004 OF A DEVICE EXPLANTATION. NO DETAILS HAVE BEEN GIVEN TO PLUS ORTHOPEDICS USA CONCERNING THE REASON FOR EXPLANTATION, THE DATE OF EXPLANTATION, WHICH OF THE 3 PRIMARY DEVICES WERE EXPLANTED, THE PT'S CURRENT STATUS, OR THE WHEREABOUTS OF ANY EXPLANTED DEVICE(S). ONLY A PT NAME WAS PROVIDED. THERE IS NO INFO AVAILABLE TO TELL IF PREVIOUS REVISIONS OF THE PRIMARY SURGERY HAVE TAKEN PLACE OR NOT. NOTIFICATION OCCURRED EXCLUSIVELY THROUGH AN ATTORNEY, ADVISING THIS OFFICE THAT A LAW SUIT HAS BEEN FILED FOR THE EXPLANTATION OF PLUS ORTHOPEDICS' PRODUCT(S).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TC-PLUS SB SOLUTION | TOTAL KNEE REPLACEMENT | JWH | PLUS ORTHOPEDICS AG | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other | PRIMARY SURGERY USED: TIBIAL INSERT 25628, TIBIAL| COMPONENT 25196, FEMORAL COMPONENT 25056. |