FDA Adverse Event
Malfunction
Summary report: N
TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL
MDR report key: 2760250
·
Received September 19, 2012
Report
- Report Number
- 9616680-2012-00779
- Event Type
- Malfunction
- Date Received
- September 19, 2012
- Date of Event
- August 27, 2012
- Report Date
- August 27, 2012
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- K013676
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
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 THE SURGEON REAMED TO 53MM WITH A 53MM REAMER AND ATTEMPTED TO IMPLANT 54MM SHELL (B)(4) AND IT WOULD NOT SEAT PROPERLY. THE SURGEON RE-REAMED WITH THE 53MM REAMER TWO MORE TIMES AND ATTEMPTED TO IMPLANT THE SHELL AND THE 54MM SHELL STILL WOULD NOT GO SO SURGEON REAMED TO 55MM AND IMPLANTED A 56MM SHELL INSTEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRIDENT HEMISPHERICAL CLUSTER HOLE SHELL | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | 36834601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |