FDA Adverse Event
Malfunction
Summary report: N
RESTORATION ADM MANCHON EXPANS
MDR report key: 1892822
·
Received November 3, 2010
Report
- Report Number
- 9616680-2010-00705
- Event Type
- Malfunction
- Date Received
- November 3, 2010
- Date of Event
- October 18, 2010
- Report Date
- October 19, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED, "WHEN TRYING TO PUT IN THE ADM CUP, HE GOT THE CUP IMPACTED AND WHEN HE WENT TO DISENGAGE THE IMPACTOR FROM THE CUP COULD NOT GET TO DISENGAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORATION ADM MANCHON EXPANS | INSTRUMENT | LXH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other |