FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1
MDR report key: 14547227
·
Received May 31, 2022
Report
- Report Number
- 3005180920-2022-00427
- Event Type
- Injury
- Date Received
- May 31, 2022
- Date of Event
- May 6, 2022
- Report Date
- May 31, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630040720205
- PMA / PMN Number
- K173794
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 09 MAY 2022: LOT 2101309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2021. EXPIRATION DATE: 2026-04-08. 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 AT 6 MONTHS FROM PRIMARY FOR STEM LOOSENING. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1599121 | STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 1 | HIP STEM CEMENTLESS | LZO | MEDACTA INTERNATIONAL SA | 01.18.431 | 2101309 | 07630040720205 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Required Intervention |