FDA Adverse Event
Injury
Summary report: N
AMISTEM COLLARED HA COATED STD STEM SIZE 0
MDR report key: 7276716
·
Received February 16, 2018
Report
- Report Number
- 3005180920-2018-00058
- Event Type
- Injury
- Date Received
- February 16, 2018
- Date of Event
- January 18, 2018
- Report Date
- February 16, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804557
- PMA / PMN Number
- K121011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 15 FEBRUARY 2018: LOT 151471: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 SEPTEMBER 2015. EXPIRATION DATE: 2020-09-05. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4)ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT HAD A PRIMARY HIP ON (B)(6) 2016. ON (B)(6) 2016 THE PATIENT CAME IN DUE TO FEELING UNSTABLE. THE PATIENT WAS DISLOCATING. THE CUP WAS ANTEVERTED. THE SURGEON REVISED THE CUP, HEAD AND LINER (B)(4). ON (B)(6) 2018 THE PATIENT WAS REVISED AGAIN. THE PATIENT CAME IN COMPLAINING OF INSTABILITY DUE TO STEM LOOSENING. THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 121659 | AMISTEM COLLARED HA COATED STD STEM SIZE 0 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 151471 | 07630030804557 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |