FDA Adverse Event
Injury
Summary report: N
TRIDENT 0 DEG INSERT 40MM
MDR report key: 2090189
·
Received May 6, 2011
Report
- Report Number
- 2249697-2011-00669
- Event Type
- Injury
- Date Received
- May 6, 2011
- Date of Event
- April 11, 2011
- Report Date
- April 11, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- K061434
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "RIGHT PRIMARY HIP SURGERY PERFORMED. PT WAS COMPLAINING OF PAIN SO IT WAS REVISED. METAL SHAVINGS WERE FOUND DURING REVISION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT 0 DEG INSERT 40MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | A4YMMA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Other| R |