FDA Adverse Event
Injury
Summary report: N
BIPOLAR HEAD Ø28X55
MDR report key: 7876599
·
Received September 14, 2018
Report
- Report Number
- 3005180920-2018-00690
- Event Type
- Injury
- Date Received
- September 14, 2018
- Date of Event
- August 17, 2018
- Report Date
- September 14, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- KWY
- UDI-DI
- 07630030843815
- PMA / PMN Number
- K091967
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 13 SEPTEMBER 2018. LOT 151038: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 JUNE 2015. EXPIRATION DATE: 2020-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION SURGERY PERFORMED DUE TO DISLOCATION 2 MONTHS AFTER PRIMARY, THE BIPOLAR HEAD POPPED OUT OF THE SOCKET. THE SURGEON REVISED THE HEAD AND BIPOLAR HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 717775 | BIPOLAR HEAD Ø28X55 | BIPOLA HEAD | KWY | MEDACTA INTERNATIONAL SA | 151038 | 07630030843815 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |