FDA Adverse Event
Injury
Summary report: N
T3 MOD REV DIST STM 15MMX225MM
MDR report key: 1030069
·
Received April 15, 2008
Report
- Report Number
- 9616680-2008-00087
- Event Type
- Injury
- Date Received
- April 15, 2008
- Date of Event
- February 6, 2008
- Report Date
- March 18, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K983404
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE NOT RETURNED. NO EVAL WILL BE PERFORMED. IF DEVICE BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT: PT HAS WHAT APPEARS TO BE A BROKEN T3 RESTORATION STEM SEEN ON AN X-RAY PHOTO. PT WAS WALKING ON FLAT GROUND WHEN HE HEARD AND FELT NOISE AND PAIN FROM HIS HIP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | T3 MOD REV DIST STM 15MMX225MM | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | TAXC706 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |