MAUDE Adverse Event Report: ENCORE MEDICAL L.P. SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS; PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 4

Catalog Number SR PIP-4

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

Patient Problem Insufficient Information (4580)

Event Date 02/10/2023

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 - required intervention to prevent impairment/damage.

• Brand Name: SEMI-CONSTRAINED METAL/POLYMER FINGER JOINT PROSTHESIS
• Type of Device: PROXIMAL INTERPHALANGEAL IMPLANT, SIZE 4
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 16491926
• MDR Text Key: 310771679
• Report Number: 1644408-2023-00253
• Device Sequence Number: 1
• Product Code: MPK
• 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
• Report Date: 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SR PIP-4
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2023
• 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