FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD STEM SIZE 5
MDR report key: 12428026
·
Received September 6, 2021
Report
- Report Number
- 3005180920-2021-00720
- Event Type
- Injury
- Date Received
- September 6, 2021
- Date of Event
- August 11, 2021
- Report Date
- September 6, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804113
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 13.AUGUST.2021. LOT 160781: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2016. EXPIRATION DATE: 2021-05-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT SINCE 2017.
Description of Event or Problem · 1
4 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1327936 | STEM: AMISTEM H HA COATED STD STEM SIZE 5 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 01.18.135 | 160781 | 07630030804113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |