FDA Adverse Event
Injury
Summary report: N
AMISTEM-P STD STEM SIZE 5
MDR report key: 9961386
·
Received April 15, 2020
Report
- Report Number
- 3005180920-2020-00032
- Event Type
- Injury
- Date Received
- April 15, 2020
- Date of Event
- January 10, 2020
- Report Date
- April 15, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630040720045
- PMA / PMN Number
- K173794
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 22-JAN-2020: LOT 1901566: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2019. EXPIRATION DATE: 11-MAY-2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS DIRECTOR: FEW WEEKS AFTER CEMENTLESS TOTAL HIP ARTHROPLASTY, THE PATIENT REPORTED PAIN DUE TO A PERIPROSTHETIC FEMORAL FRACTURE. DURING REHABILITATION PERIOD, A SUDDEN MOVEMENT ON A WEAKENED BONE DUE TO NORMAL FEMORAL PREPARATION MAY FAVOUR THE OCCURRENCE OF EARLY FRACTURE. THERE IS NO REASON TO SUSPECT A FAULTY DEVICE.
Description of Event or Problem · 1
FEMUR BONE FRACTURE 1 MONTH AFTER PRIMARY SURGERY. THE STEM HAS BEEN REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 425281 | AMISTEM-P STD STEM SIZE 5 | HIP UNCEMENTED STEM | LZO | MEDACTA INTERNATIONAL SA | 1901566 | 07630040720045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Required Intervention |