MAUDE Adverse Event Report: ENCORE MEDICAL L.P. UNI KNEE SYSTEM; INSERT, ONLAY TIBIAL, EPIK, SIZE40X10

Model Number	340-40-010
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/19/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to a poly swap.
Additional Manufacturer Narrative
The reason for this revision surgery was an unspecified poly swap.The actual length of in-vivo patient service for this product is unknown since the original surgery date was not provided or could not be established.There is no information in this complaint about any patient injuries, activities, or accidents that may have contributed to the need for this revision surgery.There are no reported pre-existing patient health conditions.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 record (dhr) was not conducted since a lot number was not provided, confirmed or determined during the complaint evaluation.The part number was not confirmed during the complaint evaluation.Multiple searches of the djo surgical records and patient database revealed no additional information concerning this event.This complaint will be closed with the lot and part unknown pending receipt of additional information.The following are undetermined items or issues for this complaint: the revision date on the product feedback form is incorrect and unconfirmed.There was no ticket submitted for original surgery.This complaint is deemed to be non-product related.The complaint states the patient underwent this revision for an unspecified poly swap.The root cause for the poly swap was not reported.No other conditions relating to this event could be determined with confidence.The surgeon reported no issues associated with the explanted product.The complaint investigation is limited in scope since the part associated with this investigation was not returned to djo surgical for evaluation.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: UNI KNEE SYSTEM
• Common Device Name: INSERT, ONLAY TIBIAL, EPIK, SIZE40X10
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6648819
• Report Number: 1644408-2017-00494
• Device Sequence Number: 1149995
• Product Code: HRY
• UDI-Device Identifier: 00888912116039
• UDI-Public: (01)00888912116039
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K020741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2017

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: 340-40-010
• Device Catalogue Number: 340-40-010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 08/18/2017
• 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