FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 4724196
·
Received April 23, 2015
Report
- Report Number
- 0002249697-2015-01358
- Event Type
- Injury
- Date Received
- April 23, 2015
- Date of Event
- October 11, 2014
- Report Date
- February 9, 2015
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JDI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS AN UNKNOWN RECONSTRUCTIVE PRODUCT. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
RIGHT KNEE OPEN LATERAL RETINACULAR RELEASE, MEDIAL REEFING WITH HAMSTRING AND PFL RECONSTRUCTION PLUS RESURFACING OF THE PATELLA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269869 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | JDI | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |