MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HXL-VE 3D INSERT 10LX11MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER

Catalog Number	391-11-710
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to patient is having discomfort so the doctor went in and did a poly swap.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to: 1644408-2019-00036: 391-09-604, s807 - pain, revision surgery.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: HXL-VE 3D INSERT 10LX11MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 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: 19494872
• Report Number: 1644408-2024-00850
• Device Sequence Number: 8558904
• Product Code: OIY
• UDI-Device Identifier: 00888912119269
• UDI-Public: 00888912119269
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K091956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/27/2016
• Device Catalogue Number: 391-11-710
• Device Lot Number: 59602033
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 70 YR
• Patient Sex: Male