FDA Adverse Event
Injury
Summary report: N
LRG TAP ORI MOD NCK 0DEG 38MM
MDR report key: 2738065
·
Received September 5, 2012
Report
- Report Number
- 9616680-2012-00725
- Event Type
- Injury
- Date Received
- September 5, 2012
- Date of Event
- August 20, 2012
- Report Date
- August 20, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS - CORK
- Product Code
- MEH
- PMA / PMN Number
- K092561
- 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 DUE TO HOSPITAL POLICY. ADD'L INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADD'L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MR# 2249697-2012-01479.
Description of Event or Problem · 1
IT WAS REPORTED THAT DR. N. REVISED PT'S LEFT HIP DUE TO ADVERSE LOCAL TISSUE REACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LRG TAP ORI MOD NCK 0DEG 38MM | IMPLANT | MEH | STRYKER ORTHOPAEDICS - CORK | NA | 26962903 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |