FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 6
MDR report key: 10224643
·
Received July 2, 2020
Report
- Report Number
- 3005180920-2020-00378
- Event Type
- Injury
- Date Received
- July 2, 2020
- Date of Event
- June 4, 2020
- Report Date
- July 2, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630040720250
- 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 16 JUNE 2020: LOT 1901536: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAY-2019. EXPIRATION DATE: 2024-05-07. 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 REPORTING THIGH PAIN DUE TO A SUBSIDED STEM. THE SURGEON 6 MONTHS AFTER PRIMARY REVISED THE STEM, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 690305 | STEM: AMISTEM-P COLLARED AMISTEM-P COLLARED STD STEM SIZE 6 | CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 1901536 | 07630040720250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |