FDA Adverse Event
Injury
Summary report: N
UNK LEFT HIP STEM
MDR report key: 2872094
·
Received December 6, 2012
Report
- Report Number
- 2249697-2012-02599
- Event Type
- Injury
- Date Received
- December 6, 2012
- Date of Event
- August 3, 2012
- Report Date
- November 15, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE PT REPORTED THAT BECAUSE OF A REVISION SURGERY ON 08/03/2012, HE HAD A FRACTURE ON HIS FEMUR. PT HAD A FRACTURE REDUCTION ON (B)(6) 2012. PT IS REPORTING THAT HE HAD THREE CABLES PLACED AROUND HIS FEMUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK LEFT HIP STEM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other| R |