FDA Adverse Event
Injury
Summary report: N
METASUL FEMORAL HEAD
MDR report key: 1880302
·
Received October 20, 2010
Report
- Report Number
- 1822565-2010-00957
- Event Type
- Injury
- Date Received
- October 20, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 4, 2010
- Manufacturer
- ZIMMER INC
- Product Code
- JDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- 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 THAT THE PT WAS REVISED FOR HIP PAIN, A PSEUDO TUMOR, AND WEAR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | METASUL FEMORAL HEAD | HIP PROSTHESIS | JDI | ZIMMER INC | 1422290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention | LOT# 1426337| INTER-OP ACETABULAR SYSTEM METASUL STANDARD INSERT| CATALOG# 437228055 |