FDA Adverse Event
Injury
Summary report: N
UNKNOWN RIGHT HIP STEM
MDR report key: 2910463
·
Received January 8, 2013
Report
- Report Number
- 2249697-2013-90074
- Event Type
- Injury
- Date Received
- January 8, 2013
- Date of Event
- January 31, 2011
- Report Date
- December 19, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDE DIN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT IS EXPERIENCING PAIN IN THE FRONT OF HIS THIGH AND UP INTO THE BUTTOCK AREA. PT STATES THAT HIS HIP PROTRUDES AT THE INCISION SITE. PT STATES HE HAS HAD THE PAIN FOR THE LAST YEAR. PT HAS HAD CORTISONE INJECTION AND PHYSICAL THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10093 | UNKNOWN RIGHT HIP STEM | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other |