MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2018-05-03 for MCP GENERIC manufactured by Ascension Orthopedics.
[107267943]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[107267944]
The department of orthopedic surgery, mayo clinic (2017) published? Outcomes following acute metacarpophalangeal joint arthroplasty dislocation: an analysis of 37 cases?. The purpose of this study was to assess the outcomes of surgical and nonsurgical treatment modalities of mcp arthroplasty dislocations. Twenty-seven (27) patients who sustained 37 acute mcp arthroplasty dislocation were the focus of the study in which 21 dislocations were treated with revision arthroplasty. Among the 21 dislocations that underwent revision arthroplasty, 15 were successful, and 6 failures were reported: 2 patients required a repeat revision arthroplasty for continuing instability and 4 experienced repeat instability without further intervention. The publication confirmed the use of integra mcp (silicone and pyrocarbon); however, it is not clear which type of mcp caused the adverse events. Several attempts were made to the author to obtain additional information and we were not able to obtain confirmation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1651501-2018-00025 |
| MDR Report Key | 7484179 |
| Report Source | LITERATURE |
| Date Received | 2018-05-03 |
| Date of Report | 2018-04-13 |
| Date Mfgr Received | 2018-05-24 |
| Date Added to Maude | 2018-05-03 |
| 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 | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS |
| Manufacturer Street | 8700 CAMERON ROAD #100 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCP GENERIC |
| Generic Name | MCP |
| Product Code | KYJ |
| Date Received | 2018-05-03 |
| Catalog Number | MCP GENERIC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | 8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-05-03 |