MAUDE Adverse Event Report: ENCORE MEDICAL L.P EMPOWR POROUS KNEE; DJO EMPOWR KNEETM, PRESS FIT BP, 8L

Model Number	353-01-108
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Event or Problem Description
Revision surgery - due to periprosthetic fracture of the proximal tibia.
Additional Manufacturer Narrative
Corrected data: manufacturer narrative: the reason for this revision surgery was reported as fracture.The previous surgery and the surgery detailed in this event occurred 17 days 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 devices were disposed of at 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 was a nonconformance associated with the main part # 353-01-108 djo empowr kneetm, press fit bp, 8l which documents that out of 10 parts in the lot 1 part was rejected and scrapped due to profile out of tolerance.All other items in the lot have met with fit, form and function requirements.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 compliant was a revision surgery due to fracture.There were no findings during this evaluation that indicate the reported devices were defective.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.Due to short time between previous and revision surgery, it is possible that the event may have occurred due to lack of post-operative care, patient activities or trauma, patient noncompliance with medical instructions or incorrect implant selection.There are multiple factors that may also contribute to an event that are outside the control of djo surgical.There are no indications of a product or process issue affecting implant safety or effectiveness.Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

• Brand Name: EMPOWR POROUS KNEE
• Common Device Name: DJO EMPOWR KNEETM, PRESS FIT BP, 8L
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin,tx 78758-5445
• MDR Report Key: 11423587
• Report Number: 1644408-2021-00149
• Device Sequence Number: 14605327
• Product Code: MBH
• UDI-Device Identifier: 00190446230069
• UDI-Public: (01)00190446230069
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 11/01/2025
• Device Model Number: 353-01-108
• Device Catalogue Number: 353-01-108
• Device Lot Number: 193W1026
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 05/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 110-02-032 LOT 395A1073; 341-12-708 LOT 112T1034
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR