FDA Adverse Event
Injury
Summary report: N
T3 STEM
MDR report key: 916280
·
Received September 19, 2007
Report
- Report Number
- 9616680-2007-00123
- Event Type
- Injury
- Date Received
- September 19, 2007
- Date of Event
- August 20, 2007
- Report Date
- August 22, 2007
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- KWY
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LEGAL ACTION HAS BEEN THREATENED IN THIS CASE, AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED: "PT RECEIVED A TWO PIECE STEM. THE STEM BROKE AT THE JUNCTION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | T3 STEM | IMPLANT | KWY | STRYKER ORTHOPAEDICS CORK | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |