FDA Adverse Event
Injury
Summary report: N
32MM STANDARD FEMORAL HEAD
MDR report key: 117951
·
Received September 2, 1997
Report
- Report Number
- 2219689-1997-00462
- Event Type
- Injury
- Date Received
- September 2, 1997
- Date of Event
- August 18, 1997
- Report Date
- August 29, 1997
- Product Code
- KWY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
SUMMARY OF EVAL: THE DEVICE WAS NOT RETURNED FOR EVAL. THEREFORE, NO EVAL WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 32MM STANDARD FEMORAL HEAD Implant | IMPLANT | KWY | B2KCN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |