FDA Adverse Event
Injury
Summary report: N
STEM: SMS SOLID STEM STD SIZE 13
MDR report key: 16917558
·
Received May 12, 2023
Report
- Report Number
- 3005180920-2023-00329
- Event Type
- Injury
- Date Received
- May 12, 2023
- Date of Event
- April 15, 2023
- Report Date
- May 12, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030888724
- PMA / PMN Number
- K181693
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 2112223: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JAN-2022. EXPIRATION DATE: 2026-DEC-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT HAD SUFFERED AN INTRA-OP FRACTURE ON (B)(6) 2023. THE FEMUR FRACTURED WHEN IMPLANTING THE STEM (THE FRACTURE WAS BELOW THE DISTAL TIP OF THE STEM). THE SURGEON DECIDED TO HAVE THE PATIENT COME BACK TO REVISE THE STEM AND HEAD. ON (B)(6) 2023, THE PATIENT CAME IN AND HAD THE STEM AND HEAD REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAD GOOD BONE QUALITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1652675 | STEM: SMS SOLID STEM STD SIZE 13 | HIP CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 01.36.053 | 2112223 | 07630030888724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Male | Required Intervention |