MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION KNEE; INSERT, CONSTRAINED, P.S., SIZE10 11MM CM

Model Number	370-11-510
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as an injury.The previous surgery and the revision detailed in this investigation occurred 9 months apart.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.The device was within its respective expiration date at the time of use during the previous surgery.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 injury.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.Agent has clearly mentioned that the patient injured, it seems that the event might have possibly occurred due to lack of post operative care, patient activities or 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 had an injury.Changed out insert while irrigation & drainage was performed.

• Brand Name: FOUNDATION KNEE
• Common Device Name: INSERT, CONSTRAINED, P.S., SIZE10 11MM CM
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin texas 78758
• MDR Report Key: 8855887
• Report Number: 1644408-2019-00728
• Device Sequence Number: 2716400
• Product Code: JWH
• UDI-Device Identifier: 00888912116657
• UDI-Public: (01)00888912116657
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K933539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2019

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: 01/31/2019
• Device Model Number: 370-11-510
• Device Catalogue Number: 370-11-510
• Device Lot Number: 59604395
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 08/02/2019
• 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: Required Intervention
• Patient Age: 75 YR