FDA Adverse Event
Injury
Summary report: N
AVON
MDR report key: 1678163
·
Received May 6, 2010
Report
- Report Number
- 9610726-2010-00144
- Event Type
- Injury
- Date Received
- May 6, 2010
- Date of Event
- March 18, 2010
- Report Date
- April 23, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- KRR
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SURGEON REMOVED AVON FEMORAL COMPONENT AND CONVERTED TO A TRIATHLON TOTAL KNEE. SURGEON COMMENTED THAT PT WAS EXPERIENCING KNEE PAIN WITH THE AVON."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AVON | IMPLANT | KRR | STRYKER ORTHOPAEDICS LIMERICK | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |