MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-24 for CUP: VERSAFITCUP ACETABULAR SHELL ? 52 01.26.52MB manufactured by Medacta International Sa.
[189010270]
Batch review performed on 24-feb-2020. Lot 083736: 46 items manufactured and released on 25-feb-2009. Expiration date: 31. 01. 2014. No anomalies found related to the problem. To date, all items of the same lot have been already sold without any other similar reported event.
Patient Sequence No: 1, Text Type: N, H10
[189010271]
The patient came in reporting pain, and the surgeon observed that the patient's posterior wall was worn away after about 11 years from the primary surgery. The surgeon replaced the posterior wall, added an augment and revised the cup, head, and liner. The surgery was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005180920-2020-00103 |
| MDR Report Key | 9744766 |
| Report Source | OTHER |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2009-02-25 |
| Date Added to Maude | 2020-02-24 |
| 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 | CUP: VERSAFITCUP ACETABULAR SHELL ? 52 |
| Generic Name | ACETABULAR SHELL |
| Product Code | MEH |
| Date Received | 2020-02-24 |
| Model Number | 01.26.52MB |
| Catalog Number | 01.26.52MB |
| Lot Number | 083736 |
| Device Expiration Date | 2014-01-31 |
| 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 | 2020-02-24 |