FDA Adverse Event
Injury
Summary report: N
16MM X 217MM BOWED PLASMA STEMRESTORATION MODULAR
MDR report key: 2190447
·
Received July 29, 2011
Report
- Report Number
- 9616680-2011-00499
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- July 6, 2011
- Report Date
- July 6, 2011
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LZO
- PMA / PMN Number
- K013106
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S STEM SUBSIDED FROM PREVIOUS REVISION SURGERY. ACETABULUM WAS LOOSE (COMPETITOR'S). PROCEEDED TO TRITANIUM REVISION SHELL AND CONE/CONICAL MOD. RESTORATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 16MM X 217MM BOWED PLASMA STEMRESTORATION MODULAR | IMPLANT | LZO | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention |