FDA Adverse Event
Injury
Summary report: N
UNKNOWN STRYKER RIGHT HIP
MDR report key: 2910686
·
Received January 8, 2013
Report
- Report Number
- 2249697-2013-90055
- Event Type
- Injury
- Date Received
- January 8, 2013
- Date of Event
- November 10, 2004
- Report Date
- December 14, 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
- IN, 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 PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT IS REPORTED THAT: PATIENT HAS HAD A DULL ACHE IN HIS HIP FOR THE PAST FEW MONTHS. PATIENT'S HIP BEGAN POPPING WITH EACH STEP A FEW WEEKS AGO. PATIENT HAS PAIN DAILY AND THE INTENSITY IS INCREASING. PATIENT IS SCHEDULING AN APPOINTMENT WITH A NEW ORTHOPAEDIST SOON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9934 | UNKNOWN STRYKER RIGHT HIP | IMPLANT | JDI | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Other |