FDA Adverse Event
Injury
Summary report: N
UNKNOWN RIGHT REJUVENATE HIP
MDR report key: 2831100
·
Received November 2, 2012
Report
- Report Number
- 2249697-2012-02173
- Event Type
- Injury
- Date Received
- November 2, 2012
- Date of Event
- October 11, 2011
- Report Date
- October 9, 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
- WI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO PERTAINING TO THE DEVICE REFERENCE IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT IS REPORTED THAT: PT IS EXPERIENCING SWELLING AND PAIN IN HIP AREA SINCE THE SURGERY, BACK, AND BUTTOCKS. PT EXPERIENCES PAIN WHILE WALKING. PT IS SCHEDULED FOR FOLLOW UP VISION WITH DOCTOR ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN RIGHT REJUVENATE HIP | IMPLANT | MEH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Other |