FDA Adverse Event
Injury
Summary report: N
MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4
MDR report key: 18814606
·
Received March 1, 2024
Report
- Report Number
- 3005180920-2024-00067
- Event Type
- Injury
- Date Received
- March 1, 2024
- Date of Event
- January 31, 2024
- Report Date
- March 1, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030809194
- 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 05-FEB-2024: LOT 2315550: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2023. EXPIRATION DATE: 2028-06-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF THE REVIEW. LOT 2309707: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUL-2023. EXPIRATION DATE: 2028-06-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE HEAD FROM THE LINER. THE SURGEON REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 307172 | MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE S - 4 | HIP CERAMIC HEAD | LZO | MEDACTA INTERNATIONAL SA | 2315550 | 07630030809194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention |