FDA Adverse Event
Injury
Summary report: N
NEXGEN MIS STEMMED TIBIAL COMPONENT
MDR report key: 1884565
·
Received October 19, 2010
Report
- Report Number
- 1822565-2010-00937
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 16, 2010
- Report Date
- September 16, 2010
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED FOR PAIN. X-RAYS SUGGESTED COMPONENT WAS LOOSE. THERE WAS NO CEMENT ATTACHED TO THE UNDERSIDE OF THE COMPONENT. CEMENT WAS INTERDIGITATED INTO CANCELLOUS BONE BUT NONE WAS FOUND ON THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN MIS STEMMED TIBIAL COMPONENT | KNEE PROSTHESIS | JWH | ZIMMER, INC. | 60326190 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |