FDA Adverse Event
Injury
Summary report: N
TRIDENT 0 X3 INSERT 36MM ID
MDR report key: 1820621
·
Received August 26, 2010
Report
- Report Number
- 2249697-2010-01156
- Event Type
- Injury
- Date Received
- August 26, 2010
- Date of Event
- August 2, 2010
- Report Date
- August 5, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K033716
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING LOT NUMBER AND MEDICAL RECORDS) WAS REQUESTED. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 6260-6-136 LOT# UNK, DESCRIPTION: V40 COCR LFIT HEAD 36MM/0. 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 INFECTION-WASHED OUT WOUND-APPEARED OK SO REPLACED PARTS THAT WERE REMOVED WITH LIKE PARTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 0 X3 INSERT 36MM ID | IMPLANT | LPH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other| R |