MAUDE Adverse Event Report: ENCORE MEDICAL L.P POSTERIOR STABILIZED KNEE; INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE8 15MM CM

Model Number	360-15-508
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/16/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery: due to an infection; the surgeon performed an irrigation & drainage and poly swap.
Additional Manufacturer Narrative
The reason for this revision surgery was an infection.The date of the original surgery is unknown.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.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 part number reported on the initial medical device report can not be confirmed.The part and/or 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.In addition to the lot and/or part 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.Attempts were made to obtain the part and/or lot numbers of the devices that were removed; however, this information was not available.Without this information, this investigation is limited in scope.If additional information can be provided at a later time, this investigation shall be re-evaluated.The root cause of this complaint was a revision surgery due to an infection.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 devices removed during the revision surgery, it is impossible to determine the source of the infection.

• Brand Name: POSTERIOR STABILIZED KNEE
• Common Device Name: INSERT, POSTERIOR STABILIZED, SERIES 500, SIZE8 15MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 6645436
• Report Number: 1644408-2017-00514
• Device Sequence Number: 926337
• Product Code: JWH
• UDI-Device Identifier: 00888912116497
• UDI-Public: (01)00888912116497
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 08/09/2017

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: 360-15-508
• Device Catalogue Number: 360-15-508
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 08/09/2017
• 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