MAUDE Adverse Event Report: SILICONE MCP SZ 10

Catalog Number SMCP-500-10-WW

Device Problem Break (1069)

Patient Problem Implant Pain (4561)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

3 of 3 reports.Other mfg report numbers: 1651501-2021-00037, 1651501-2021-00038.A patient reported that she had three (3) fractured implants, and she needed another surgery.The patient received a right-hand joint replacement with silicone implants on (b)(6) 2019.Upon visit with the patient¿s new hand surgeon, it was discovered on x-ray that 3 replacement joints of her right-hand finger were completely broken.The replacement joints broke at or under the two-year mark.The broken implanted joints were creating more pressure, bone spurs and pain on her hand joints.No other clinical information has been provided.

Manufacturer Narrative

The silicone mcp sz 10 was not returned for evaluation therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: SILICONE MCP SZ 10
• Type of Device: SILICONE MCP
• MDR Report Key: 12409114
• MDR Text Key: 269435235
• Report Number: 1651501-2021-00039
• Device Sequence Number: 1
• Product Code: KYJ
• Combination Product (y/n): N
• PMA/PMN Number: K022892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: SMCP-500-10-WW
• Device Lot Number: 185041T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Date Device Manufactured: 11/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1