MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-13 for LINER: MPACT DOUBLE MOBILITY HC LINER ? 54/28 01.26.2854MHC manufactured by Medacta International Sa.
[175049624]
Batch review performed on 20 december 2019. Lot 1903332: (b)(4) items manufactured and released on 24-jul-2019. Expiration date: 2024-07-08. 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. Additional implant involved in the event, batch review performed on 20 december 2019. Ball heads: mectacer 01. 29. 202 biolox delta ceramic ball head 12/14? 28 size m 0 (k112115) lot. 1903847 lot 1903847: (b)(4) items manufactured and released on 26-jul-2019. Expiration date: 2024-07-13. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold with one similar event reported.
Patient Sequence No: 1, Text Type: N, H10
[175049625]
The patient came in, one month after primary surgery, due to signs of infection and the pathogen is unknown. The surgeon performed a washout and revised the head and liner. The surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2019-01141 |
| MDR Report Key | 9580570 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2019-07-24 |
| Date Added to Maude | 2020-01-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR STEFANO BAJ |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, SWITZERLAND 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 6874 |
| Manufacturer G1 | MEDACTA INTERNATIONAL SA |
| Manufacturer Street | STRADA REGINA |
| Manufacturer City | CASTEL SAN PIETRO, 6874 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 6874 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINER: MPACT DOUBLE MOBILITY HC LINER ? 54/28 |
| Generic Name | DOUBLE MOBILITY HC LINER |
| Product Code | MEH |
| Date Received | 2020-01-13 |
| Catalog Number | 01.26.2854MHC |
| Lot Number | 1903332 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDACTA INTERNATIONAL SA |
| Manufacturer Address | STRADA REGINA CASTEL SAN PIETRO, 6874 SZ 6874 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-13 |