FDA Adverse Event
Injury
Summary report: N
AMISTEM C CEMENTED STD STEM SIZE 3
MDR report key: 13963367
·
Received March 31, 2022
Report
- Report Number
- 3005180920-2022-00212
- Event Type
- Injury
- Date Received
- March 31, 2022
- Date of Event
- March 3, 2022
- Report Date
- March 31, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804281
- PMA / PMN Number
- K103189
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2022: LOT 2002910:(B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JULY-2020. EXPIRATION DATE: 2025-07-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
REVISION SURGERY WAS PERFORMED ABOUT 1 YEAR AFTER PRIMARY DUE TO STEM LOOSENING. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR IMPLANTS AND REVISED THE DM MEDACTA LINER WITH A DM MEDACTA LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2188943 | AMISTEM C CEMENTED STD STEM SIZE 3 | HIP CEMENTED STEM | LZO | MEDACTA INTERNATIONAL SA | 01.18.153 | 2002910 | 07630030804281 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Female | Required Intervention |