MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-06 for LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMI 01.26.2858MHC manufactured by Medacta International Sa.
[177999437]
Batch review performed on 15 january 2020: lot 1902877: (b)(4) items manufactured and released on 21-jun-2019. Expiration date: 2025-06-05. 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.
Patient Sequence No: 1, Text Type: N, H10
[177999438]
The patient had a primary hip surgery and was implanted with competitor items. The date of the primary surgery is unknown. Subsequently on (b)(6) 2019, the patient came in due to metallosis in the hip. The surgeon revised the patient with a medacta liner. Presently, on (b)(6) 2020, about 2 months after primary, the patient came in reporting pain due to a dislocation of the head from the liner. The surgeon revised the competitor head and medacta liner.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2020-00023 |
| MDR Report Key | 9675221 |
| Report Source | OTHER |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2019-06-21 |
| Date Added to Maude | 2020-02-06 |
| 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: VERSAFITCUP DM DOUBLE MOBILITY HC LINER 28/DMI |
| Generic Name | DOUBLE MOBILITY HC LINER |
| Product Code | MEH |
| Date Received | 2020-02-06 |
| Model Number | 01.26.2858MHC |
| Catalog Number | 01.26.2858MHC |
| Lot Number | 1902877 |
| 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 | 2020-02-06 |