FDA Adverse Event
Malfunction
Summary report: N
HIP
MDR report key: 1071761
·
Received July 3, 2008
Report
- Report Number
- 9616680-2008-00184
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 13, 2008
- Report Date
- June 17, 2008
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADD'L INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF ADD'L INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, "PT PRESENTED WITH SQUEAKING HIP. AUDIBLE TO OTHER EMPLOYEES AT THE OFFICE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIP | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |