FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM C CEMENTED STD SIZE 1
MDR report key: 12141632
·
Received July 9, 2021
Report
- Report Number
- 3005180920-2021-00570
- Event Type
- Injury
- Date Received
- July 9, 2021
- Date of Event
- June 16, 2021
- Report Date
- July 9, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804267
- PMA / PMN Number
- K103189
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 17 JUNE 2021: LOT 150156: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2015. EXPIRATION DATE: 2020-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE (B)(6) 2017.
Description of Event or Problem · 1
THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. 5 YEARS AND 7 MONTHS AFTER PRIMARY THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR IMPLANTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1040306 | STEM: AMISTEM C CEMENTED STD SIZE 1 | CEMENTED FEMORAL STEM | LZO | MEDACTA INTERNATIONAL SA | 01.18.151 | 151722 | 07630030804267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |