FDA Adverse Event
Injury
Summary report: N
BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M
MDR report key: 16655292
·
Received March 31, 2023
Report
- Report Number
- 3005180920-2023-00222
- Event Type
- Injury
- Date Received
- March 31, 2023
- Date of Event
- March 3, 2023
- Report Date
- March 31, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030809163
- PMA / PMN Number
- K112115
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 22 MARCH 2023:LOT 2213115: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-AUG-2022. EXPIRATION DATE: 2027-08-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.
Description of Event or Problem · 0
REVISION SURGERY FOR INFECTION. AT ABOUT 1 MONTH POST PRIMARY SURGERY ONLY THE CERAMIC HEAD WAS REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 528959 | BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 32 SIZE M | HIP CERAMIC BALL HEAD | LZO | MEDACTA INTERNATIONAL SA | 01.29.205 | 2213115 | 07630030809163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention |