FDA Adverse Event
Injury
Summary report: N
TRIDENT ALL POLY CUP-CROSSFIRE
MDR report key: 2221274
·
Received August 17, 2011
Report
- Report Number
- 2249697-2011-01203
- Event Type
- Injury
- Date Received
- August 17, 2011
- Date of Event
- July 24, 2011
- Report Date
- July 24, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- K012026
- 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 INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6034-0730, LOT # MJNOT3, DESCRIPTION: OMNIFIT NORMALIZED HIP STEM MOLD#950. CAT # 06-3210, LOT # MHD7X, DESCRIPTION: C-TAPER COCR LFIT HEAD 32MM/+10. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "POSSIBLE INFECTIONS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT ALL POLY CUP-CROSSFIRE | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other| R |