FDA Adverse Event
Injury
Summary report: N
DELTA V-40 CERAMIC HEAD 36/-5
MDR report key: 2234028
·
Received August 29, 2011
Report
- Report Number
- 9616680-2011-00570
- Event Type
- Injury
- Date Received
- August 29, 2011
- Date of Event
- July 7, 2008
- Report Date
- August 11, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K023901
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
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 "PT BROKE HIS HIP IN 2006 AND RECEIVED AN UNIDENTIFIED HEMIARTHROPLASTY HIP. ON (B)(6)-2007 THE PT HAD PAIN, AND A REVISION WAS PERFORMED, DUE TO A LOOSE, FAILED HEMIARTHROPLASTY STEM. THIS WAS REPLACED WITH A TOTAL HIP. ON (B)(6)-2008 ANOTHER REVISION WAS PERFORMED DUE TO FAILURE OF THE RIGHT TOTAL HIP ARTHROPLASTY, RECEIVING A BIOLOX DELTA CERAMIC V40 HEAD 36MM, RESTORATION MODULAR HIP CONE BODY, AND RESTORATION CONICAL DISTAL STEM. ON (B)(6)-2008 THE PT WAS TREATED FOR A RIGHT PERIPROSTHETIC FEMUR FRACTURE. SYNTHESE SCREWS, AND PINS AND CABLE WERE IMPLANTED. OPEN REDUCTION AND FIXATION OF RIGHT FEMUR FRACTURE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DELTA V-40 CERAMIC HEAD 36/-5 | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | 25985702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Required Intervention |