FDA Adverse Event
Injury
Summary report: N
STEM: SMS SOLID SMS SOLID STEM STD SIZE 6
MDR report key: 14461323
·
Received May 20, 2022
Report
- Report Number
- 3005180920-2022-00382
- Event Type
- Injury
- Date Received
- May 20, 2022
- Date of Event
- April 22, 2022
- Report Date
- May 20, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030888656
- PMA / PMN Number
- K181693
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 25 APRIL 2022. LOT 2112213: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-DEC-2021. EXPIRATION DATE: 2026-11-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
AT 3 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS A PERIPROSTHETIC FRACTURE. THE SURGEON REVISED THE HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION: THE SURGEON DECIDED TO NOT REVISE THE STEM BECAUSE IT WAS NOT LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1522065 | STEM: SMS SOLID SMS SOLID STEM STD SIZE 6 | HIP STEM CEMENTLESS | LZO | MEDACTA INTERNATIONAL SA | 01.36.046 | 2112213 | 07630030888656 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |