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

Model Number	380-09-506
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as an poly wear.The previous surgery and the revision detailed in this investigation occurred 13 year and 1 month apart.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 event.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 implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.The root cause of this complaint was a revision surgery due to poly wear.There were no findings during this investigation that indicate that the reported device (s) was the source or had a direct connection with the patient's event.There are many factors that may contribute to the event that are outside the control of djo surgical are degenerative bone disease, excessive range of motion, excessive loading, aging of the patient, patient activities and trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - patient presented with discomfort.Surgeon felt it was poly wear due to age of implant.
Additional Manufacturer Narrative
Corrected data: expiration date and device manufacture date where not reported on the initial medical device report.Changing first paragraph: the reason for this revision surgery was reported as an poly wear.The previous surgery and the revision detailed in this investigation occurred 13 year and 1 month apart.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 event.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 was disposed of at the hospital and not made available to djo surgical for examination.A review of the implant device history records (dhrs) show that the reported component used in the previous surgery met design and manufacturing requirements.There were no non-conforming material reports (ncmrs) associated with the product that may have contributed to the event.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The device was verified to have gone through an acceptable sterilization process and was within it's expiration date at the time of use during the previous surgery.The root cause of this complaint was a revision surgery due to poly wear.There were no findings during this investigation that indicate that the reported device was the source or had a direct connection with the patient's event.There are many factors that may contribute to the event that are outside the control of djo surgical are degenerative bone disease, excessive range of motion, excessive loading, aging of the patient, patient activities and trauma.No additional information was submitted with the complaint regarding pre-existing conditions of the patient or any activities that may have contributed to the event and hence a definitive root cause cannot be determined.There are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: FOUNDATION KNEE
• Common Device Name: INSERT, ULTRA CONGRUENT SIZE6 9MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8783043
• Report Number: 1644408-2019-00637
• Device Sequence Number: 2038078
• Product Code: JWH
• UDI-Device Identifier: 00888912117067
• UDI-Public: (01)00888912117067
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K963028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2006
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

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: 03/31/2010
• Device Model Number: 380-09-506
• Device Catalogue Number: 380-09-506
• Device Lot Number: 419632
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 07/11/2019
• 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: 71 YR