FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3
MDR report key: 9002440
·
Received September 12, 2019
Report
- Report Number
- 3005180920-2019-00762
- Event Type
- Injury
- Date Received
- September 12, 2019
- Date of Event
- August 14, 2019
- Report Date
- September 12, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630040720021
- PMA / PMN Number
- K173794
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 22 AUGUST 2019. LOT 1900063: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2019. EXPIRATION DATE: 2024-04-14. 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
THE PATIENT CAME IN, 2 WEEKS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO A FRACTURE CAUSED BY A SUBSIDED STEM. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 806939 | STEM: AMISTEM P AMISTEM-P STD STEM SIZE 3 | HIP CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 1900063 | 07630040720021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |