FDA Adverse Event
Injury
Summary report: N
BALL HEADS: BIPOLAR HEAD 25060.2844 BIPOLAR HEAD Ø28X44
MDR report key: 16385149
·
Received February 16, 2023
Report
- Report Number
- 3005180920-2023-00049
- Event Type
- Injury
- Date Received
- February 16, 2023
- Date of Event
- January 19, 2023
- Report Date
- February 16, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- KWY
- UDI-DI
- 07630030843594
- PMA / PMN Number
- K091967
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 20 JANUARY 2023: LOT 1901960: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JULY-2019. EXPIRATION DATE: 2024-07-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE BIPOLAR SHELL FROM THE ACETABULUM. THE CAUSE OF THE DISLOCATION IS UNKNOWN. AT ABOUT 2 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE PATIENT FROM A HEMI TO A TOTAL HIP. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 360221 | BALL HEADS: BIPOLAR HEAD 25060.2844 BIPOLAR HEAD Ø28X44 | HIP BIPOLAR HEAD | KWY | MEDACTA INTERNATIONAL SA | 25060.2844 | 1901960 | 07630030843594 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |