FDA Adverse Event
Other
Summary report: N
PERFORM. PS FEM. COMPONENT
MDR report key: 106651
·
Received July 17, 1997
Report
- Report Number
- 1825034-1997-00053
- Event Type
- Other
- Date Received
- July 17, 1997
- Report Date
- July 15, 1997
- Manufacturer
- BIOMET, INC.
- Product Code
- HSA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE MEDWATCH REPORT THAT WAS SENT ON 7/15/97, STATED THE PART NUMBER AS 7404PS170. FURTHER INVESTIGATION SHOWS THAT THE PART NUMBER IS ACTUALLY 7604PS178.
Description of Event or Problem · 1
DEVICE WAS RETURNED TO CO FROM A FOREIGN COMPANY REP. THE DEVICE WAS EXPLANTED FOR UNK REASONS. NO OTHER INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PERFORM. PS FEM. COMPONENT Implant | PROSTHESIS, KNEE, COMP. | HSA | BIOMET, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |