FDA Adverse Event
Injury
Summary report: N
"AVON PFL AND PATELLA"
MDR report key: 1661819
·
Received April 14, 2010
Report
- Report Number
- 9610726-2010-00114
- Event Type
- Injury
- Date Received
- April 14, 2010
- Date of Event
- March 30, 2010
- Report Date
- March 31, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS LIMERICK
- Product Code
- HTG
- 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 EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SURGEON EXPLANTED AVON COMPONENT. HE COMMENTED THAT PATELLA WAS VERY LOOSE. REMOVED PATELLA AND CONVERTED TO A PRIMARY TRIATHLON. SURGEON COMMENTED PATIENT WAS EXPERIENCING KNEE PAIN WHICH WAS THE REASON FOR REVISION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | "AVON PFL AND PATELLA" | IMPLANT | HTG | STRYKER ORTHOPAEDICS LIMERICK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |