MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION POSTERIOR STABILIZED (PS) KNEE; INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 13MM CM

Catalog Number	360-13-506
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to the patient having an infection.
Additional Manufacturer Narrative
The reason for this revision surgery was an infection.The date of the original surgery is only known to have happened in 2006, an exact implant length of in-vivo can not be calculated.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.This investigation is limited in scope as limited information was provided to djo surgical - austin for review.The lot number of the device involved in this event was not provided; the complaint states it was unreadable.Attempts were made to obtain the lot number of the device that was removed; however, this information was not available.To adequately investigate this event, the part and/lot number are necessary.In addition to the lot number not being supplied, information regarding cultures identified in the infection and the severity of the infection was not supplied.If this information is submitted at a future date, this investigation will be re-evaluated.The root cause of this complaint was a revision surgery due to an infection.No information was submitted with the complaint regarding pre-existing conditions of the patient or any activities the patient was involved in that may have contributed to the infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside of the control of djo surgical.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 infection.Containment based on the information submitted with this complaint it is not possible as the agent was unable to supply the lot number.

• Brand Name: FOUNDATION POSTERIOR STABILIZED (PS) KNEE
• Common Device Name: INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE6 13MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6481380
• Report Number: 1644408-2017-00241
• Device Sequence Number: 1289104
• Product Code: JWH
• UDI-Device Identifier: 00888912116411
• UDI-Public: (01)00888912116411
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K933539
• 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): 05/18/2017

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 Catalogue Number: 360-13-506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/11/2017
• Supplement Report FDA Received Date: 05/18/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 67 YR