FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 2931244
·
Received January 28, 2013
Report
- Report Number
- 0002249697-2013-00343
- Event Type
- Injury
- Date Received
- January 28, 2013
- Date of Event
- January 8, 2013
- Report Date
- January 8, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- MEH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS 48MM VITALOCK SOLID BACK SHELL AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS DISPOSED AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.
Description of Event or Problem · 1
IT WAS REPORTED: ACETABULAR CUP REVISION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37723 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | MEH | STRYKER ORTHOPAEDICS-MAHWAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |