MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; INSERT, STD., PRIMARY, SIZE4 13MM CM

Model Number	385-13-504
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Scar Tissue (2060)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - the surgeon did a poly exchange due to range of motion with scar tissue.
Additional Manufacturer Narrative
The reason for this revision surgery was a poly exchange due to range of motion with scar tissue.The in-vivo length of patient service for the implant was 1.6 years.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 records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed as non-product related.The root cause for this event was the patient had scar tissue and a range of motion issue.The scope of this investigation is limited without having the explanted parts available to djo surgical for evaluation.Other conditions relating to this event could not 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, STD., PRIMARY, SIZE4 13MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6994323
• Report Number: 1644408-2017-00988
• Device Sequence Number: 16439967
• Product Code: JWH
• UDI-Device Identifier: 00888912117920
• UDI-Public: (01)00888912117920
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K000590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2017

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 Expiration Date: 10/31/2020
• Device Model Number: 385-13-504
• Device Catalogue Number: 385-13-504
• Device Lot Number: 498B1031
• 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: 11/29/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 12/14/2017
• 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
• Patient Age: 54 YR