FDA Adverse Event
Injury
Summary report: N
M/H INTERLOK (NTS)
MDR report key: 351781
·
Received September 14, 2001
Report
- Report Number
- 1825034-2001-00081
- Event Type
- Injury
- Date Received
- September 14, 2001
- Date of Event
- December 12, 1998
- Report Date
- August 14, 2001
- Manufacturer
- BIOMET, INC.
- Product Code
- JDT
- Removal / Correction Number
- Z-1064/1069-5
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT LEFT TOTAL HIP ARTHROPLASTY WAS PERFORMED IN 1991. REVISION PERFORMED IN 1998, DUE TO FRACTURE OF FEMORAL STEM PROSTHESIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42288 | M/H INTERLOK (NTS) | PROSTHESIS, HIP, COMP. | JDT | BIOMET, INC. | NA | 716380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Hospitalization| R |