FDA Adverse Event
Injury
Summary report: N
M/H INTERLOK (NTS)
MDR report key: 356545
·
Received October 16, 2001
Report
- Report Number
- 1825034-2001-00095
- Event Type
- Injury
- Date Received
- October 16, 2001
- Date of Event
- September 13, 1999
- Report Date
- October 15, 2001
- Manufacturer
- BIOMET, INC.
- Product Code
- JDT
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
TOTAL HIP ARTHROPLASTY PERFORMED IN 1992. REVISION PERFORMED IN 1999, DUE TO FRACTURE OF FEMORAL STEM COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46305 | M/H INTERLOK (NTS) | PROSTHESIS, HIP, COMP. | JDT | BIOMET, INC. | NA | 436820 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |