FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED LAT STEMSIZE 0
MDR report key: 9361086
·
Received November 22, 2019
Report
- Report Number
- 3005180920-2019-00976
- Event Type
- Injury
- Date Received
- November 22, 2019
- Date of Event
- October 24, 2019
- Report Date
- November 22, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804168
- PMA / PMN Number
- K121011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 5 NOVEMBER 2019. LOT 163105: 35 ITEMS MANUFACTURED AND RELEASED ON 12-AUG-2016. EXPIRATION DATE: 2021-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION SURGERY PREFORMED 1 YEAR AND 5 MONTHS AFTER THE PRIMARY DUE TO INSTABILITY CAUSED BY A LOOSE STEM. THE PATIENT HAD POOR BONE QUALITY. THE SURGEON REVISED THE HEAD, STEM, AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1160743 | STEM: AMISTEM H HA COATED LAT STEMSIZE 0 | CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 163105 | 07630030804168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |