MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; INSERT, ULTRA CONGRUENT SIZE2 9MM CM

Catalog Number	380-09-502
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - patient presented post operation with pain.Poly wear suspected.Insert was replaced.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2018-00766, 385-09-502, s805 - wear/excessive wear, 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: FOUNDATION KNEE
• Common Device Name: INSERT, ULTRA CONGRUENT SIZE2 9MM CM
• 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: 18204826
• Report Number: 1644408-2023-01690
• Device Sequence Number: 12378063
• Product Code: JWH
• UDI-Device Identifier: 00888912117043
• UDI-Public: (01)00888912117043
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/24/2023

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 Catalogue Number: 380-09-502
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/24/2023
• 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: 79 YR
• Patient Sex: Female