MAUDE Adverse Event Report: ENCORE MEDICAL L.P DISC XS CONDYLE KIT W/ HEXALOB; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Model Number	540-00-004
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/11/2023
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 poly wear.
Additional Manufacturer Narrative
Complaint has been reassessed and determined to be not reportable unknown disc part.

• Brand Name: DISC XS CONDYLE KIT W/ HEXALOB
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• 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: 17066684
• Report Number: 1644408-2023-00690
• Device Sequence Number: 15147510
• Product Code: JDC
• UDI-Device Identifier: 00190446137979
• UDI-Public: 00190446137979
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K090473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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): 06/27/2023

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 Model Number: 540-00-004
• Device Catalogue Number: 540-00-004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 06/27/2023
• 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: Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female