FDA Adverse Event
Injury
Summary report: N
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4
MDR report key: 19390100
·
Received May 24, 2024
Report
- Report Number
- 3005180920-2024-00348
- Event Type
- Injury
- Date Received
- May 24, 2024
- Date of Event
- April 29, 2024
- Report Date
- May 24, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030809156
- PMA / PMN Number
- K112115
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 06 MAY 2024: LOT 2303242: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MARCH-2023. EXPIRATION DATE: 2028-02-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 9 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2333144 | MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE S -4 | HIP CERAMIC BALL HEAD | LZO | MEDACTA INTERNATIONAL SA | 2303242 | 07630030809156 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention |