FDA Adverse Event
Injury
Summary report: N
MPACT ACETABULAR SHELL Ø56 MULTI-HOLE
MDR report key: 6646018
·
Received June 16, 2017
Report
- Report Number
- 3005180920-2017-00314
- Event Type
- Injury
- Date Received
- June 16, 2017
- Date of Event
- May 18, 2017
- Report Date
- June 16, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LPH
- PMA / PMN Number
- K132879
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 161062: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: 06/06/2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. NOT AVAILABLE.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON NOTICED THAT THE CUP WAS LOOSE. THE SURGEON REVISED CUP, HEAD, LINER AND SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 426997 | MPACT ACETABULAR SHELL Ø56 MULTI-HOLE | CEMENTLESS ACETABULAR SHELL | LPH | MEDACTA INTERNATIONAL SA | 161062 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |