MAUDE Adverse Event Report: ENCORE MEDICAL L.P SILICONE II MCP IMPLANT SIZE 30 (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER

Catalog Number MCP-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 10/26/2023

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Revision surgery - due to pain.

Manufacturer Narrative

The reason for this revision surgery, it was reported as, revision surgery: "pain and range of motion original case done before djo acquired this product./.61" the actual length of in-vivo for the item(s) listed is unknown as the original surgery date was not provided or could be established.This investigation is limited in scope as only partial information was provided to djo surgical - austin for review.The revised item(s) was not returned for examination and the item and or lot number(s) was not provided.To adequately investigate this event, the part and lot number(s) are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.Customer complaint history of the reported item(s) showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.

• Brand Name: SILICONE II MCP IMPLANT SIZE 30 (STERILE PACKED)
• Type of Device: PROSTHESIS, FINGER, CONSTRAINED, POLYMER
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18188588
• MDR Text Key: 328739662
• Report Number: 1644408-2023-01649
• Device Sequence Number: 1
• Product Code: KYJ
• UDI-Device Identifier: 00886385022130
• UDI-Public: 00886385022130
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MCP-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2023
• 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: 61 YR
• Patient Sex: Female