FDA Adverse Event
Injury
Summary report: N
ALUMINA V40-FEMORAL HEAD 36MM, -5MM NK
MDR report key: 2162126
·
Received July 5, 2011
Report
- Report Number
- 9616680-2011-00443
- Event Type
- Injury
- Date Received
- July 5, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 15, 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
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. NO FURTHER INFORMATION IS AVAILABLE, ALTHOUGH, IT HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS MFR# 9616680-2011-00444.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "PATIENT HAD POSSIBLE INFECTION. THE HEAD AND LINER WAS REMOVED AND A NEW HEAD AND LINER WAS IMPLANTED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALUMINA V40-FEMORAL HEAD 36MM, -5MM NK | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | 75810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |