FDA Adverse Event
Malfunction
Summary report: N
PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM
MDR report key: 1850385
·
Received September 20, 2010
Report
- Report Number
- 2249697-2010-01247
- Event Type
- Malfunction
- Date Received
- September 20, 2010
- Date of Event
- August 27, 2010
- Report Date
- August 27, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- LPH
- PMA / PMN Number
- K081171
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT: "PREPARED ACETABULUM FOR INSERTION OF PRIMARY TITANIUM ACETABULAR CUP, SURGEON REAMED LINE TO LINE AND IMPACTED; IT FAILED TO RIGID FIXATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM | IMPLANT | LPH | STRYKER ORTHOPAEDICS MAHWAH | NA | MHNEOX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |