FDA Adverse Event
Injury
Summary report: N
STEM: SMS SOLID STEM STD SIZE 4
MDR report key: 16938633
·
Received May 16, 2023
Report
- Report Number
- 3005180920-2023-00349
- Event Type
- Injury
- Date Received
- May 16, 2023
- Date of Event
- April 20, 2023
- Report Date
- May 16, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030888632
- 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 21-APR-2023. LOT 2210281: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-OCT-2022. EXPIRATION DATE: 2027-10-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC BONE FRACTURE AND THE CAUSE IS UNKNOWN. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1165261 | STEM: SMS SOLID STEM STD SIZE 4 | HIP STEM CEMENTLESS | LZO | MEDACTA INTERNATIONAL SA | 01.36.044 | 2210281 | 07630030888632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |