FDA Adverse Event
Injury
Summary report: N
AMISTEM H CEMENTLESS STEM SIZE 1 STD
MDR report key: 5285782
·
Received December 10, 2015
Report
- Report Number
- 3005180920-2015-00316
- Event Type
- Injury
- Date Received
- December 10, 2015
- Date of Event
- November 10, 2015
- Report Date
- March 9, 2016
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2015: LOT 143129: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2014. EXPIRATION DATE: 2019-06-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Additional Manufacturer Narrative · 1
ON 08 FEBRUARY 2016, IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON THE SAME DATE, THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.
Description of Event or Problem · 1
THE SURGEON NOTICED THE PATIENTS STEM WAS SUBSIDING. HE FELT THE PATIENT WAS AT RISK OF POTTING. HE DECIDED TO REMOVE AND REPLACE THE STEM AND BALL HEAD. THERE ARE NO X-RAYS THE EXPLANTS WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 817139 | AMISTEM H CEMENTLESS STEM SIZE 1 STD | FEMORAL CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 143129 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |