FDA Adverse Event
Injury
Summary report: N
SHOULDER SYSTEM
MDR report key: 20459397
·
Received October 16, 2024
Report
- Report Number
- 3005180920-2024-00819
- Event Type
- Injury
- Date Received
- October 16, 2024
- Date of Event
- September 16, 2024
- Report Date
- November 15, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- PHX
- UDI-DI
- 07630040706353
- PMA / PMN Number
- K170452
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 23 SEPTEMBER 2024 LOT 2103703: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-JULY-2021. EXPIRATION DATE: 2026-07-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Additional Manufacturer Narrative · 0
ADDITIONAL INFORMATION REPORTED IN THE SECTION B5 DESCRIBE EVENT OR PROBLEM: PATIENT'S BONE QUALITY POOR.
Description of Event or Problem · 0
AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE GLENOID BASEPLATE. THE CAUSE OF THE LOOSE GLENOID BASEPLATE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT TO AN ANATOMIC SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Description of Event or Problem · 0
PATIENT'S BONE QUALITY POOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1353345 | SHOULDER SYSTEM | GLENOID BASEPLATE | PHX | MEDACTA INTERNATIONAL SA | 04.01.0148 | 2103703 | 07630040706353 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |