FDA Adverse Event
Injury
Summary report: N
CUP: MPACT ACETABULAR SHELL 50 NO-HOLE
MDR report key: 12157188
·
Received July 13, 2021
Report
- Report Number
- 3005180920-2021-00576
- Event Type
- Injury
- Date Received
- July 13, 2021
- Date of Event
- June 21, 2021
- Report Date
- July 13, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LPH
- UDI-DI
- 07630030810787
- PMA / PMN Number
- K132879
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 22 JUNE 2021: LOT 2000212: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2020. EXPIRATION DATE: 2025-04-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION SURGERY 1 YEAR AFTER PRIMARY BECAUSE THE CUP WAS TOO CRANIAL AND MEDIALIZED. CUP, HEAD AND LINER REVISED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1059246 | CUP: MPACT ACETABULAR SHELL 50 NO-HOLE | ACETABULAR SHELL | LPH | MEDACTA INTERNATIONAL SA | 01.32.150SH | 2000212 | 07630030810787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Required Intervention |