FDA Adverse Event
Malfunction
Summary report: N
ZMR HIP SYSTEM TAPER STEM
MDR report key: 2142132
·
Received May 26, 2011
Report
- Report Number
- 1822565-2011-01240
- Event Type
- Malfunction
- Date Received
- May 26, 2011
- Date of Event
- April 22, 2011
- Report Date
- April 28, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- LPH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT UPON OPENING THE STEM, IT WAS FOUND PROTRUDING THROUGH THE INNER AND OUTER PACKAGING. THE SURGEON REAMED UP AND IMPLANTED A LARGER SIZE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZMR HIP SYSTEM TAPER STEM | LPH | ZIMMER, INC. | 60079888 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |