FDA Adverse Event
Injury
Summary report: N
TRIDENT 10 CROSSFIRE INSERT 36 MM ID
MDR report key: 1873597
·
Received October 12, 2010
Report
- Report Number
- 2249697-2010-01333
- Event Type
- Injury
- Date Received
- October 12, 2010
- Date of Event
- September 16, 2010
- Report Date
- September 16, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K021911
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "PT HAD REVISION DUE TO FAILED ACETABULAR COMPONENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 10 CROSSFIRE INSERT 36 MM ID | IMPLANT | LPH | STRYKER ORTHOPAEDICS MAHWAH | NA | 1ZLNJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Other| R |