FDA Adverse Event
Other
Summary report: N
CONSENSUS BIPOLAR HEAD, COCR, SZ.43MM
MDR report key: 199996
·
Received November 25, 1998
Report
- Report Number
- 2952369-1998-00007
- Event Type
- Other
- Date Received
- November 25, 1998
- Date of Event
- October 22, 1998
- Report Date
- November 20, 1998
- Manufacturer
- HAYES MEDICAL, INC.
- Product Code
- KWY
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CONSENSUS BIPOLAR HEAD/INSERT ASSEMBLY WAS IMPLANTED BY A DR. ON 10/06/98. ON 10/22/98 THE PT " FELL TO THE GROUND." UPON EXAMINATION IT WAS DISCOVERED THAT THE HEMI-HIP IMPLANT HAD DISLOCATED FROM THE PT'S ACETABULUM. A CLOSED REDUCTION WAS ATTEMPTED, BUT WAS UNSUCCESSFUL. X-RAYS INDICATED THAT AFTER THE ATTEMPTED CLOSED REDUCTION OF THE JOINT, THE 28MM FEMORAL HEAD WAS DISASSOCIATED FROM THE BIPOLAR HEAD/INSERT ASSEMBLY. REVISION SURGERY WAS REQUIRED TO REPLACE AND RELOCATE THE HEMI-HIP IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONSENSUS BIPOLAR HEAD, COCR, SZ.43MM Implant | 888.3400 HIP JOINT FEMORAL | KWY | HAYES MEDICAL, INC. | NA | 420024 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| O| R | 2. CONSENSUS BIPOLAR INSERT, SZ. 42-44MM| 1. CONSENSUS FEMORAL STEM, NP, COCR, SZ.8| 3. CONSENSUS FEMORAL HEAD, COCR, 22MM |