FDA Adverse Event
Injury
Summary report: N
AMISTEM H, HA COATED STD SIZE 4 STEM
MDR report key: 6376239
·
Received March 3, 2017
Report
- Report Number
- 3005180920-2017-00091
- Event Type
- Injury
- Date Received
- March 3, 2017
- Date of Event
- February 2, 2017
- Report Date
- March 3, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON 17 FEBRUARY 2017 THE MEDICAL AFFAIRS DIRECTOR PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: EARLY POSTOPERATIVE FRACTURE AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY IN A (B)(6) YEAR OLD PATIENT. THE FRACTURE MAY BE DUE TO A TRAUMATIC EVENT OCCURRED DURING THE WALKING RE-EDUCATION PERIOD. NO REASON TO SUSPECT THAT THIS EVENT IS DUE TO A FAULTY DEVICE. BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 153126: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 OCTOBER 2015. EXPIRATION DATE: 2020-09-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.
Description of Event or Problem · 1
REVISION DUE TO PERIPROSTHETIC FRACTURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159938 | AMISTEM H, HA COATED STD SIZE 4 STEM | CEMENTLESS FEMORAL STEM | LZO | MEDACTA INTERNATIONAL SA | 153126 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |