FDA Adverse Event
Injury
Summary report: N
TRIATHLON-PRIM TIB BASEPLATE CEMENTED #7
MDR report key: 2234031
·
Received August 29, 2011
Report
- Report Number
- 9610726-2011-00298
- Event Type
- Injury
- Date Received
- August 29, 2011
- Date of Event
- August 9, 2011
- Report Date
- August 9, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- JWH
- PMA / PMN Number
- K031729
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF REC'D WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE BASEPLATE WAS UNDERSIZED AND COLLAPSED MEDIALLY SO THE SURGEON REVISED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIATHLON-PRIM TIB BASEPLATE CEMENTED #7 | IMPLANT | JWH | STRYKER ORTHOPAEDICS LIMERICK | NA | SAX6J |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |