FDA Adverse Event
Injury
Summary report: N
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S
MDR report key: 8230873
·
Received January 9, 2019
Report
- Report Number
- 3005180920-2018-01074
- Event Type
- Injury
- Date Received
- January 9, 2019
- Date of Event
- December 10, 2018
- Report Date
- January 9, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030809194
- PMA / PMN Number
- K112115
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 08 JANUARY 2019: LOT 163456: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-OCT-2016. EXPIRATION DATE: 2021-09-22. 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.
Description of Event or Problem · 1
ABOUT 2 MONTHS AFTER PRIMARY THE SURGEON REVISED PATIENT CERAMIC HEAD AND THE COMPETITOR LINER FOR AN INFECTION CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 24764 | MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S | CERAMIC BALL HEAD | LZO | MEDACTA INTERNATIONAL SA | 163456 | 07630030809194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |