FDA Adverse Event
Injury
Summary report: N
OMNIFIT NORMALIZED HIP STEM MOLD #745
MDR report key: 2226768
·
Received August 24, 2011
Report
- Report Number
- 2249697-2011-01229
- Event Type
- Injury
- Date Received
- August 24, 2011
- Date of Event
- July 24, 2011
- Report Date
- August 1, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K913812
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF ADDITIONAL INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT# 2041C-2854, LOT# 56754801, DESCRIPTION: CROSSFIRE 10 DEG INSERT. CAT# 06-2800, LOT# 56068301, DESCRIPTION: C-TAPER COCR LFIT HEAD 28MM/0. CAT# 2072-0054, LOT# LV3055, DESCRIPTION: DUAL GEO.M/S SCREWLESS CUP 54MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S PAIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PT COMPLAINED OF PAIN."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNIFIT NORMALIZED HIP STEM MOLD #745 | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | 94V548 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other| R |