FDA Adverse Event
Other
Summary report: N
UNKNOWN PRODUCT
MDR report key: 2132175
·
Received June 6, 2011
Report
- Report Number
- 9616680-2011-00372
- Event Type
- Other
- Date Received
- June 6, 2011
- Date of Event
- April 17, 2007
- Report Date
- May 16, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MRA
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- 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. ADD'L INFO WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
AN ADVERSE EVENT WAS REPORTED FOR PT NO (B)(6) IN THE (B)(6) STUDY AT (B)(6). THE SURGEON REPORTED TO CRM THAT THE PT SUFFERED FROM DEEP VENOUS THROMBOSIS OF CONTRA-LATERAL CALF 1 MONTH AND 4 DAYS POST OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT | IMPLANT | MRA | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Death |