FDA Adverse Event
Injury
Summary report: N
UNKNOWN 28MM CERAMIC LINER SIZE D
MDR report key: 2232470
·
Received August 25, 2011
Report
- Report Number
- 9616680-2011-00554
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- August 3, 2011
- Report Date
- August 3, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- JDI
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THERE WAS CLICKING SOUND IN THE HIP AND DOCTOR EXAMINED IN THE OFFICE, TOOK X-RAYS AND DECIDED TO REVISE THE PATIENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN 28MM CERAMIC LINER SIZE D | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |