FDA Adverse Event
Injury
Summary report: N
STEM COLLARED HA COATED STD STEM SIZE 9 LOT
MDR report key: 8004509
·
Received October 25, 2018
Report
- Report Number
- 3005180920-2018-00823
- Event Type
- Injury
- Date Received
- October 25, 2018
- Date of Event
- October 19, 2018
- Report Date
- October 25, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804649
- 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 24 OCTOBER 2018. LOT 133237: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 OCTOBER 2013. EXPIRATION DATE: 2018-08-31. 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
ABOUT 1 YEAR AND 10 MONTHS AFTER PRIMARY THE SURGEON PLANS A REVISION ON THE PATIENT HIP FOR STEM LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 845630 | STEM COLLARED HA COATED STD STEM SIZE 9 LOT | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 133237 | 07630030804649 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |