FDA Adverse Event
Injury
Summary report: N
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M 0
MDR report key: 12119683
·
Received July 6, 2021
Report
- Report Number
- 3005180920-2021-00554
- Event Type
- Injury
- Date Received
- July 6, 2021
- Date of Event
- June 10, 2021
- Report Date
- July 6, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030809200
- PMA / PMN Number
- K112115
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 16 JUNE 2021: LOT 162733: 118 ITEMS MANUFACTURED AND RELEASED ON 12-AGO-2016. EXPIRATION DATE: 2021-07-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2017. PRELIMINARY INVESTIGATION PERFORMED BY R&D PROJECT MANAGER ON THE IMAGES RECEIVED NO CONCLUSION ON THE ROOT CAUSE OF THE EVENT CAN BE TRACED.
Description of Event or Problem · 1
REVISION SURGERY 4 YEARS AND 9 MONTHS AFTER PRIMARY FOR LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE CERAMIC HEAD SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1017643 | BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 36 SIZE M 0 | CERAMIC BALL HEAD | LZO | MEDACTA INTERNATIONAL SA | 01.29.209 | 162733 | 07630030809200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |