FDA Adverse Event
Injury
Summary report: N
STEM COLLARED HA COATED STD STEM SIZE 2
MDR report key: 7868587
·
Received September 12, 2018
Report
- Report Number
- 3005180920-2018-00670
- Event Type
- Injury
- Date Received
- September 12, 2018
- Date of Event
- August 13, 2018
- Report Date
- September 12, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804571
- PMA / PMN Number
- K121011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2018. LOT 132994: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 SEPTEMBER 2013. EXPIRATION DATE: 2018-07-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
ABOUT 4 YEARS AND A HALF AFTER PRIMARY, THE SURGEON REVISED THE PATIENT FOR STEM POTTING. STEM, HEAD AND LINER SWAP PERFORMED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712211 | STEM COLLARED HA COATED STD STEM SIZE 2 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 132994 | 07630030804571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |