MAUDE Adverse Event Report: ENCORE MEDICAL L.P. 3DKNEE; INSERT, 3D EX SZ 8LT 15MM

Model Number	391-15-708
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was knee instability.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhr) was not conducted since the item and or lot number was not provided or determined during the complaint evaluation.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.Given the limited information, a search for an invoice of the previous surgery produced no results.The root cause of this complaint was a revision surgery due to knee being unstable.There was no information submitted with the complaint that would indicate a material, design, or manufacturing issue with the explanted part.Should addition information become available this complaint shall be re-opened and a further evaluation well be conducted.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - the patient's knee was unstable; needed to increase insert size.

• Brand Name: 3DKNEE
• Common Device Name: INSERT, 3D EX SZ 8LT 15MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 8742782
• Report Number: 1644408-2019-00588
• Device Sequence Number: 11272758
• Product Code: OIY
• UDI-Device Identifier: 00888912119771
• UDI-Public: (01)00888912119771
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K091956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: 391-15-708
• Device Catalogue Number: 391-15-708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR