MCP GENERIC

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number1651501-2018-00025
MDR Report Key7484179
Report SourceLITERATURE
Date Received2018-05-03
Date of Report2018-04-13
Date Mfgr Received2018-05-24
Date Added to Maude2018-05-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactUSER VIVIAN NELSON
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1ASCENSION ORTHOPEDICS
Manufacturer Street8700 CAMERON ROAD #100
Manufacturer CityAUSTIN TX 78754
Manufacturer CountryUS
Manufacturer Postal Code78754
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMCP GENERIC
Generic NameMCP
Product CodeKYJ
Date Received2018-05-03
Catalog NumberMCP GENERIC
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerASCENSION ORTHOPEDICS
Manufacturer Address8700 CAMERON ROAD #100 8700 CAMERON ROAD #100 AUSTIN TX 78754 US 78754


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-05-03

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