MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; INSERT, ULTRA CONGRUENT SIZE4 19MM CM

Model Number	380-19-504
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the poly wearing over time and screw becoming loose.
Additional Manufacturer Narrative
The reason for this revision surgery was a worn poly and a loose screw.The actual length of in-vivo patient service for this product is unknown as the original surgery date was not provided or could 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 or determined during the complaint evaluation.Multiple searches of the djo surgical records by surgeon and patient database revealed no additional information concerning this event.No additional information was obtained from the agent to assist in the event identification.Should zimmer-biomet provide additional information concerning this complaint, the complaint will be re-opened and a further review shall be conducted.This complaint will be closed with the lot number unknown pending receipt of additional information.The following are undetermined items or issues for this complaint: the date of the original surgery on the product feedback form was not provided.There was no dticket submitted for the original surgery.This complaint is deemed to be non-product related.The complaint states the patient had a worn poly insert and the lock down screw for the poly was reported as loose.This revision was necessary to correct the patient's condition.No other conditions relating to this event could be determined with confidence.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION KNEE
• Common Device Name: INSERT, ULTRA CONGRUENT SIZE4 19MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6994389
• Report Number: 1644408-2017-00974
• Device Sequence Number: 11014528
• Product Code: JWH
• UDI-Device Identifier: 00888912117364
• UDI-Public: (01)00888912117364
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K963028
• 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): 12/04/2017

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: 380-19-504
• Device Catalogue Number: 380-19-504
• Device Lot Number: 59604784
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 12/04/2017
• 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