FDA Adverse Event
Injury
Summary report: N
DURACON CRUC BEADED B/P M2
MDR report key: 1855136
·
Received September 30, 2010
Report
- Report Number
- 9610726-2010-00341
- Event Type
- Injury
- Date Received
- September 30, 2010
- Date of Event
- September 14, 2010
- Report Date
- September 14, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- MBH
- PMA / PMN Number
- K032163
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "PT CAME INTO SURGEON'S OFFICE COMPLAINING OF KNEE DISCOMFORT. X-RAYS WERE TAKEN. REVISION KNEE WAS SCHEDULED. BROKEN COMPONENT WAS REMOVED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURACON CRUC BEADED B/P M2 | IMPLANT | MBH | STRYKER ORTHOPAEDICS LIMERICK | NA | L4MJH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |