MAUDE Adverse Event Report: ENCORE MEDICAL L.P. FOUNDATION KNEE; FEMUR, POSTERIOR STABILIZED, NONPOROUS, REVISION, SIZE10, LT

Model Number	205-01-010
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was reported as pain and instability.The previous surgery and the surgery detailed in this event occurred 1 year and 10 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 were disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhr) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There were no non-conformance material reports (ncmr) associated with the products that may have contributed to the reported event.The devices were verified to have gone through an acceptable sterilization process and were within its expiration date at the time of the previous surgery.Customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.The root cause of this complaint was a revision surgery due to pain and instability.There were no findings during this evaluation that indicate the reported devices were defective.No information was submitted with the complaint regarding any activities the patient was involved in that may have contributed to the event.Agent has clearly mentioned "the patient is grossly overweight and suffers from diabetes and other health issues".There are multiple factors that may contribute to an event that are outside the control of djo surgical such as poor bone density, patient bone deterioration, excessive loading, inadequate soft tissue support, excessive range of motion, patient activities or trauma.There are no indications of a product or process issue affecting implant safety or effectiveness.
Event or Problem Description
Revision surgery - the patient presented with pain and instability.Patient is grossly overweight and suffers from diabetes and other health issues.It was discovered that both the tibia and the femur had loosened.All components were removed.More augments were used as well as the thicker poly.

• Brand Name: FOUNDATION KNEE
• Common Device Name: FEMUR, POSTERIOR STABILIZED, NONPOROUS, REVISION, SIZE10, LT
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9139333
• Report Number: 1644408-2019-00934
• Device Sequence Number: 11659426
• Product Code: JWH
• UDI-Device Identifier: 00888912109642
• UDI-Public: (01)00888912109642
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K964008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 09/30/2019

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: 09/30/2019
• Device Model Number: 205-01-010
• Device Catalogue Number: 205-01-010
• Device Lot Number: 752A1010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 10/01/2019
• 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: 71 YR