FDA Adverse Event
Injury
Summary report: N
AMISTEM C CEMENTED LAT STEM SIZE 1
MDR report key: 8845661
·
Received July 31, 2019
Report
- Report Number
- 3005180920-2019-00648
- Event Type
- Injury
- Date Received
- July 31, 2019
- Date of Event
- July 9, 2019
- Report Date
- July 31, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030803796
- PMA / PMN Number
- K103189
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 19 JULY 2019: LOT 152942: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10.08.2015. EXPIRATION DATE: 2020-06. 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. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: BASED ON ANALYSIS OF THE PICTURES, IMPLANT, AND PACKAGING WE CAN INFER THAT THERE WERE EXTREME HANDLING CONDITIONS THAT RESULTED IN THE PACKAGING DAMAGE.
Description of Event or Problem · 1
THE SURGEON DISCOVERED DURING THE SURGERY, THE INNER BLISTER OF AMISTEM-C WAS BROKEN. THE SURGERY WAS COMPLETED WITH THE BACKUP IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639004 | AMISTEM C CEMENTED LAT STEM SIZE 1 | CEMENTED HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 152942 | 07630030803796 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |