MAUDE Adverse Event Report: STRYKER GMBH SILICONE II MCP IMPLANT SIZE 20 (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number MCP-20

Device Problem Material Invagination (1336)

Patient Problem Failure of Implant (1924)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

As reported: "taken out old implants putting in new ones.Patient had fused wrist implants, had collapsed over time.Had to be taken out in pieces".

• Brand Name: SILICONE II MCP IMPLANT SIZE 20 (STERILE PACKED)
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11735103
• MDR Text Key: 247951658
• Report Number: 0008031020-2021-00193
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385022116
• UDI-Public: 00886385022116
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MCP-20
• Device Catalogue Number: MCP20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR