FDA Adverse Event
Other
Summary report: N
CONSENSUS BIPOLAR HEAD, COCR, SZ.46
MDR report key: 200113
·
Received November 30, 1998
Report
- Report Number
- 2952369-1998-00006
- Event Type
- Other
- Date Received
- November 30, 1998
- Date of Event
- October 12, 1998
- Report Date
- November 12, 1998
- Manufacturer
- HAYES MEDICAL, INC.
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CONSENSUS BIPOLAR HEAD/INSERT ASSEMBLY WAS IMPLANTED BY M.D. ON 8/6/98. APPROX 2 MONTHS POST OPERATIVELY, THE PT FELL DOWN AND DISLOCATED THE BIPOLAR ASSEMBLY FROM THE ACETABULUM. A CLOSED REDUCTION OF THE IMPLANT WAS ATTEMPTED WITHOUT SUCCESS. X-RAYS INDICATED THAT THE 28MM FEMORAL HEAD DISASSOCIATED FROM THE BIPOLAR ASSEMBLY. REVISION SURGERY WAS REQUIRED IN ORDER TO REPLACE/RELOCATE THE HEMI HIP IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSENSUS BIPOLAR HEAD, COCR, SZ.46 Implant | 888.3400 HIP JOINT FEMORAL | KWY | HAYES MEDICAL, INC. | NA | 420111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| O| R | CONSENSUS FEMORAL HEAD (28MM), COCR,| CONSENSUS BIPOLAR INSERT, UHMWPE.| CONSENSUS FEMORAL STEM, POROUS TI |