FDA Adverse Event
Injury
Summary report: N
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE M 0
MDR report key: 11341974
·
Received February 18, 2021
Report
- Report Number
- 3005180920-2021-00131
- Event Type
- Injury
- Date Received
- February 18, 2021
- Date of Event
- January 21, 2021
- Report Date
- February 18, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030809248
- 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 18-FEB-2021: LOT 151735: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-OCT-2015. EXPIRATION DATE: 2020-OCT-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017.
Description of Event or Problem · 1
THE PATIENT CAME IN REPORTING PAIN DUE TO IMPINGEMENT OF THE HEAD ON THE PSOAS, 4 YEARS AND 7 MONTHS AFTER THE PRIMARY. THE SURGEON REVISED THE HEAD AND LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 239305 | BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 40 SIZE M 0 | CERAMIC BALL HEAD | LZO | MEDACTA INTERNATIONAL SA | 01.29.213 | 151735 | 07630030809248 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |