FDA Adverse Event
Injury
Summary report: N
UNISYN TOTAL HIP SYSTEM
MDR report key: 861759
·
Received June 6, 2007
Report
- Report Number
- 2952369-2007-00001
- Event Type
- Injury
- Date Received
- June 6, 2007
- Date of Event
- May 25, 2007
- Report Date
- June 4, 2007
- Manufacturer
- HAYES MEDICAL, INC.
- Product Code
- JDI
- PMA / PMN Number
- 003649
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MFR INITIAL EVALUATION HAS BEEN LIMITED TO REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 470365. THE DHR DEMONSTRATES THAT THIS LOT WAS PRODUCED IN CONFORMITY WITH ALL PRODUCT, PROCESS AND MATERIAL SPECIFICATIONS. MFR HAS REQUESTED ACCESS TO THE EXPLANTED DEVICE FOR FURTHER EVALUATION.
Description of Event or Problem · 1
RECEIVED A REPORT THAT THE NECK COMPONENT OF A UNISYN MODULAR HIP IMPLANT SYSTEM IMPLANTED IN A PATIENT HAD FRACTURED. REVISION SURGERY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNISYN TOTAL HIP SYSTEM | JDI, LZO, MEH | JDI | HAYES MEDICAL, INC. | UNISYN STD. NECK | 4700365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |