MAUDE Adverse Event Report: STRYKER GMBH SILICONE II MCP IMPLANT SIZE 40 (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Model Number MCP-40

Device Problem Naturally Worn (2988)

Patient Problem Failure of Implant (1924)

Event Date 10/06/2021

Event Type  Injury  

Event Description

It was reported the implants were worn, requiring revision surgery.

Manufacturer Narrative

The device has not been returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

• Brand Name: SILICONE II MCP IMPLANT SIZE 40 (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: kristen canter ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12775918
• MDR Text Key: 280892973
• Report Number: 0008031020-2021-00446
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385022154
• UDI-Public: 00886385022154
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MCP-40
• Device Catalogue Number: MCP40
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2021
• 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
• Patient Sex: Female