FDA Adverse Event
Other
Summary report: N
DE PUY
MDR report key: 21111
·
Received February 9, 1994
Report
- Report Number
- 21111
- Event Type
- Other
- Date Received
- February 9, 1994
- Date of Event
- November 2, 1993
- Report Date
- December 26, 1993
- Manufacturer
- DE PUY, INC.
- Product Code
- JDO
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
IMPLANTATION PERFORMED 9/21/93 DUE TO SEVERE DEGENERATIVE CHANGES & PAIN IN RIGHT HIP. WOUND HEMATOMA EVAUCATED 1 WK POST THR. DISCHARGED FOR APPROXIMATELY 10 DAYS, RETURNEING WITH FEBER OF 100.8 & RIGHT THIGH PAIN. IMPLANT WAS SURGICALLY REMOVED & REPLACED ON 11/2/93.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DE PUY Implant | TOTAL HIP PROSTHETIC | JDO | DE PUY, INC. | SEE ATTACHED 3 RD PAGE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 * | Other |