MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION PRIMARY KNEE; INSERT, STD., PRIMARY, SIZE6 9MM CM

Model Number	385-09-506
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery: the patient presented with laxity due to poly wear.The surgeon replaced the poly with a thicker insert.
Additional Manufacturer Narrative
The reason for this revision surgery was laxity.It was reported the original surgery occured in 1993, month and day not provided.The previous surgery and the revision detailed in this investigation occurred over 24 years apart.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device has not made available to djo surgical for examination.The lot number was not supplied with the complaint and searches of the patient database did not revealed the lot number or other supporting information.Without this information, this investigation is limited in scope.If any other relevant information is submitted at a future date, this investigation will be re-evaluated.The root cause of the revision surgery was identified as laxity due to poly wear.There are multiple factors that may contribute to the event that are outside the control of djo surgical are excessive weight, unbalanced joint, patient bone deterioration or trauma.Since the event occurred after 24 years after previous surgery, the event might happened due to prolonged usage of the product.With the limited information provided about the patient and the device removed during the revision surgery, it is impossible to determine the source of the event.

• Brand Name: FOUNDATION PRIMARY KNEE
• Common Device Name: INSERT, STD., PRIMARY, SIZE6 9MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6616411
• Report Number: 1644408-2017-00417
• Device Sequence Number: 736781
• Product Code: JWH
• UDI-Device Identifier: 00888912117746
• UDI-Public: (01)00888912117746
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K923277
• 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): 07/18/2017

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: 385-09-506
• Device Catalogue Number: 385-09-506
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 07/18/2017
• 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: Other; Required Intervention
• Patient Age: 76 YR