FDA Adverse Event
Injury
Summary report: N
MPACT FLAT PE HC LINER Ø36/G
MDR report key: 7398591
·
Received April 5, 2018
Report
- Report Number
- 3005180920-2018-00204
- Event Type
- Injury
- Date Received
- April 5, 2018
- Date of Event
- March 5, 2018
- Report Date
- April 5, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LPH
- UDI-DI
- 07630030812156
- PMA / PMN Number
- K103721
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2018. LOT 121159: 65 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012. EXPIRATION DATE: (B)(6) 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 59 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
ABOUT 2 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A HIP INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 243085 | MPACT FLAT PE HC LINER Ø36/G | FLAT LINER | LPH | MEDACTA INTERNATIONAL SA | 121159 | 07630030812156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |