FDA Adverse Event
Injury
Summary report: N
MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 3
MDR report key: 7637648
·
Received June 26, 2018
Report
- Report Number
- 3005180920-2018-00464
- Event Type
- Injury
- Date Received
- June 26, 2018
- Date of Event
- May 29, 2018
- Report Date
- June 26, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030885631
- PMA / PMN Number
- K160289
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 25 JUNE 2018; LOT 160297: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 APRIL 2016. EXPIRATION DATE: 2021-04-12; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4)ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE STEM HAD SUBSIDED 2 MONTHS AFTER THE PRIMARY. THE CAUSE OF THE SUBSIDENCE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 481777 | MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 3 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 160297 | 07630030885631 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |