FDA Adverse Event
Injury
Summary report: N
MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 12
MDR report key: 12432606
·
Received September 7, 2021
Report
- Report Number
- 3005180920-2021-00711
- Event Type
- Injury
- Date Received
- September 7, 2021
- Date of Event
- August 9, 2021
- Report Date
- September 7, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030885723
- PMA / PMN Number
- K151531
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 02 SEPTEMBER 2021: LOT 162136: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2016. EXPIRATION DATE: 2021-05-22. 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 SINCE 2017.
Description of Event or Problem · 1
THE PATIENT HAD A PRIMARY TOTAL LEFT HIP SURGERY ON (B)(6) 2019. THE PATIENT DISLOCATED POST-OPERATIVELY, AND ON (B)(6) 2019, THE SURGEON REVISED THE STEM, HEAD, AND LINER. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1331269 | MASTERLOC CEMENTLESS TI COATED LAT STEM SIZE 12 | HIP CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 01.39.212 | 162136 | 07630030885723 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |