FDA Adverse Event
Injury
Summary report: N
AMISTEM H HA COATED STD STEM SIZE 3
MDR report key: 7544737
·
Received May 25, 2018
Report
- Report Number
- 3005180920-2018-00366
- Event Type
- Injury
- Date Received
- May 25, 2018
- Date of Event
- April 25, 2018
- Report Date
- May 25, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804090
- 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 24 MAY 2018: LOT 140008: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MARCH 2014. EXPIRATION DATE: 2019-02-28. 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
REVISION SURGERY PERFORMED DUE TO STEM LOOSENING AFTER ABOUT 4 YEARS FROM PRIMARY. THE SURGEON DETERMINED THE STEM WAS LOSE PROXIMALLY, YET WELL FIXED DISTALLY. THE SURGEON REVISED THE STEM, HEAD AND LINER USING ANOTHER COMPANY'S STEM AND HEAD WITH A MEDACTA LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 387859 | AMISTEM H HA COATED STD STEM SIZE 3 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 140008 | 07630030804090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |