MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION PRIMARY KNEE; INSERT, STD., PRIMARY, SIZE8 9MM CM

Catalog Number	385-09-508
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient falling, it caused loosening of the tibial insert.
Additional Manufacturer Narrative
The reason for this revision surgery was loosening of the tibial insert.The exact date of the original surgery was is unknown, it was reported to have occured in 2002.This was not verified.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.The lot number of the device involved in this event was not provided.To adequately investigate this event, the part and/or lot number are necessary.If this information is submitted at a future date, this investigation will be re-evaluated.The root cause of the loosening of the tibial insert was the patient fell.Containment based on the information submitted with this complaint it is not possible as the agent was unable to supply the lot number or the date of the previous surgery.

• Brand Name: FOUNDATION PRIMARY KNEE
• Common Device Name: INSERT, STD., PRIMARY, SIZE8 9MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6298058
• Report Number: 1644408-2017-00040
• Device Sequence Number: 13646487
• Product Code: JWH
• UDI-Device Identifier: 00888912117760
• UDI-Public: (01)00888912117760
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K000590
• 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): 03/21/2017

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 Catalogue Number: 385-09-508
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/02/2017
• Supplement Report FDA Received Date: 03/21/2017
• 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: 69 YR
• Patient Weight: 88