FDA Adverse Event
Injury
Summary report: N
SROM FEM NMH X SML 66 X 58 W/PIN L
MDR report key: 410507
·
Received August 15, 2002
Report
- Report Number
- 1818910-2002-00492
- Event Type
- Injury
- Date Received
- August 15, 2002
- Date of Event
- June 12, 2002
- Report Date
- August 15, 2002
- Manufacturer
- DEPUY-RAYNHAM/A DIV OF DEPUY ORTHOPAEDICS, INC.
- Product Code
- JWH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE SALES REP PHONED TO REPORT A PHONE CALL FROM A SURGEON. THE SURGEON SAID ONE OF THE HINGED KNEE PRODUCTS HAD BROKEN WHEN THE PATIENT FELL. THE SCREW BECAME DISASSOCIATED WHERE THE SLEEVE CONNECTS WITH THE FEMORAL STEM. THE SALES REP WAS TOLD THE PATIENT FELL PRIOR TO THE REVISON SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SROM FEM NMH X SML 66 X 58 W/PIN L | TOTAL KNEE PROSTHESIS | JWH | DEPUY-RAYNHAM/A DIV OF DEPUY ORTHOPAEDICS, INC. | NA | 221404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |