MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-26 for LINER: VERSAFITCUP DM DOUBLE MOBILITY HC LINER ? 58/28 01.26.2858MHC manufactured by Medacta International Sa.
[188741589]
Batch review performed on 07. Feb. 2020: lot 187929: (b)(4) items manufactured and released on 29-nov-2018. Expiration date: 2023-11-08. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any other similar event reported. Additional device involved: batch review performed on 07. Feb. 2020: ball heads: mectacer 01. 29. 202 biolox delta ceramic ball head 12/14 28 size m 0 (k112115) lot 187071: (b)(4) items manufactured and released on 6-dec-2018. Expiration date: 2023-11-21. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any other similar event reported.
Patient Sequence No: 1, Text Type: N, H10
[188741590]
Revision surgery needed after 9 months from the primary due to signs of an infection. 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 | 3005180920-2020-00090 |
| MDR Report Key | 9755009 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-01-27 |
| Device Manufacturer Date | 2018-11-29 |
| Date Added to Maude | 2020-02-26 |
| 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 ? 58/28 |
| Generic Name | HIP SHELL LINER |
| Product Code | MEH |
| Date Received | 2020-02-26 |
| Model Number | 01.26.2858MHC |
| Catalog Number | 01.26.2858MHC |
| Lot Number | 187929 |
| 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 | 2020-02-26 |