FDA Adverse Event
Malfunction
Summary report: N
T3 MOD REV DIST STM 19MMX225MM
MDR report key: 1030281
·
Received April 15, 2008
Report
- Report Number
- 9616680-2008-00092
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- February 16, 2008
- Report Date
- March 18, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- KWY
- PMA / PMN Number
- K983404
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT WAS GETTING OUT OF A CHAIR AND FELT A CLUNK FROM HIS HIP. FOLLOW-UP X-RAYS SHOW THAT HE APPEARS TO HAVE A BROKEN T3 RESTORATION STEM. THE DEVICE REMAINS IMPLANTED AND NO REVISION SURGERY HAS BEEN SCHEDULED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | T3 MOD REV DIST STM 19MMX225MM | IMPLANT | KWY | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |