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

Model Number	MCP-40
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the implants were worn, requiring revision surgery.
Additional 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)
• Common Device Name: 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
• Report Number: 0008031020-2021-00446
• Device Sequence Number: 19704381
• Product Code: KYJ
• UDI-Device Identifier: 00886385022154
• UDI-Public: 00886385022154
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female