FDA Adverse Event
Injury
Summary report: N
UNK M/L TAPER STEM
MDR report key: 3971000
·
Received July 8, 2014
Report
- Report Number
- 1822565-2014-00821
- Event Type
- Injury
- Date Received
- July 8, 2014
- Report Date
- June 10, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THE PATIENT HAD AN ML TAPER REMOVED FOLLOWING A PERIPROSETHIC FRACTURE. DURING SURGERY, IT WAS DISCOVERED THERE WAS FILM AROUND THE STEM INDICATING LOOSENING PRIOR TO THE FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397863 | UNK M/L TAPER STEM | HIP PROSTHESIS | LZO | ZIMMER, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |