FDA Adverse Event
Injury
Summary report: N
UNKNONW PRODUCT - CERAMIC LINER
MDR report key: 2233988
·
Received August 31, 2011
Report
- Report Number
- 9616680-2011-00574
- Event Type
- Injury
- Date Received
- August 31, 2011
- Date of Event
- August 16, 2011
- Report Date
- August 16, 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
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "THAT DOCTOR CALLED REP SAYING THEY HAD A PATIENT WITH A CERAMIC ON CERAMIC HIP THEY THOUGHT THE LINER WAS FRACTURED. WHEN THE PATIENT ARRIVED AT THE HOSPITAL THE X-RAY SHOWED THAT PART OF THE LINER HAD FRACTURED AND WAS OUTSIDE OF THE JOINT. DURING THE SURGERY, THEY DISCOVERED THAT THE TITANIUM INSERT WAS IN PLACE BUT, ALL THE CERAMIC MATERIAL HAD BROKEN AWAY FROM THE INSERT. THE HEAD WAS STILL IN PLACE AND LOOKED NORMAL EXCEPT FOR THE DISCOLORATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNONW PRODUCT - CERAMIC LINER | IMPLANT | JDI | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |