FDA Adverse Event
Injury
Summary report: N
RIGHT MODULAR HIP STEM
MDR report key: 2885203
·
Received December 17, 2012
Report
- Report Number
- 2249697-2012-02701
- Event Type
- Injury
- Date Received
- December 17, 2012
- Date of Event
- November 8, 2011
- Report Date
- November 29, 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
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT COMPLAINTS OF RADIATING PAIN IN HIP AREA AND DOWN THE GROIN. PT REPORTS INABILITY TO BEND LEG. SHE STATES THAT SHE HAS LIMITED FLEXIBILITY THAT HAS PROGRESSIVELY BECOME WORSE. MRI AND BLOOD TESTS ARE SCHEDULED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIGHT MODULAR HIP STEM | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other |