FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1
MDR report key: 11086056
·
Received December 29, 2020
Report
- Report Number
- 3005180920-2020-00970
- Event Type
- Injury
- Date Received
- December 29, 2020
- Date of Event
- December 7, 2020
- Report Date
- December 29, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630040720007
- 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 18-DIC-2020 LOT 1900061: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2019. EXPIRATION DATE: 2024-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT
Description of Event or Problem · 1
THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM, 1 YEAR 4 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE AMISTEM-P STD. #1 WITH A SMS SOLID STEM STD #10 AND REVISED THE 32MM BIOLOX DELTA HEAD S WITH A 32MM BIOLOX DELTA HEAD S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1555000 | STEM: AMISTEM P AMISTEM-P STD STEM SIZE 1 | CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 1900061 | 07630040720007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |