FDA Adverse Event
Injury
Summary report: N
AMISTEM H HA COATED STD STEM SIZE 3
MDR report key: 16893762
·
Received May 9, 2023
Report
- Report Number
- 3005180920-2023-00346
- Event Type
- Injury
- Date Received
- May 9, 2023
- Date of Event
- April 17, 2016
- Report Date
- May 9, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804090
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2023: LOT 163095: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2016. EXPIRATION DATE: 2021-AUG-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
REVISION SURGERY WAS PERFORMED ABOUT 6 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY DUE TO STEM MOBILIZATION. STEM WAS REVISED WITH A COMPETITOR STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639206 | AMISTEM H HA COATED STD STEM SIZE 3 | HIP CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 01.18.133 | 163095 | 07630030804090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |