FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD STEM SIZE 5
MDR report key: 10366568
·
Received August 5, 2020
Report
- Report Number
- 3005180920-2020-00496
- Event Type
- Injury
- Date Received
- August 5, 2020
- Date of Event
- July 16, 2020
- Report Date
- August 5, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804113
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 153128: 100 ITEMS MANUFACTURED AND RELEASED ON 09-SEP-2015. EXPIRATION DATE: 2020-07-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 79 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.
Description of Event or Problem · 1
THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE HEAD, STEM, AND LINER 4 YEARS AND 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 833100 | STEM: AMISTEM H HA COATED STD STEM SIZE 5 | HIP CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 01.18.135 | 153128 | 07630030804113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |