FDA Adverse Event
Injury
Summary report: N
UNKNOWN DURACON PS 25MM INSERT
MDR report key: 2415095
·
Received January 10, 2012
Report
- Report Number
- 9616680-2012-00026
- Event Type
- Injury
- Date Received
- January 10, 2012
- Date of Event
- December 20, 2011
- Report Date
- December 20, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JEC
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFO BECOMES AVAILABLE THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THE PATELLA WAS SUBLUXING. INITIALLY, THE SURGERY WAS TO RESURFACE THE PATELLA. THE SURGEON THEN DECIDED TO INCREASE INSERT SIZE TO IMPROVE STABILITY. IT WAS THEN DISCOVERED DURING IMPLANTATION OF THE NEW INSERT THAT THE LOCKING SCREW THAT CAME WITH, AND WAS IMPLANTED WITH THE INITIAL INSERT, HAD SHEARED OFF. THIS DAMAGED SCREW WAS THEN USED TO IMPLANT THE NEW INSERT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DURACON PS 25MM INSERT | IMPLANT | JEC | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other| R |