MAUDE Adverse Event Report: ENCORE MEDICAL L. P. EMPOWR PARTIAL KNEE; EMPOWR PARTIAL KNEETM, TIBIAL BASEPLATE, NP, SIZE 1, LM-RL

Model Number 357-01-101

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/16/2021

Event Type  Injury  

Manufacturer Narrative

Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.

Event Description

Reported incident - due to patient underwent uka procedure.Post-operative films looked fine.Patient fractured medial tibial plateau soon after surgery, directly below implant keel.Required plating and screws to buttress tibia, correct alignment and induce fracture healing.

Manufacturer Narrative

Manufacturer narrative: the reason for this revision surgery was was a revision surgery due to the patient fractured medial tibial plateau.The previous surgery and the surgery detailed in this event occurred 14 days apart.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery.The revision surgery was completed as intended.The device was not made available to djo surgical for examination.A review of the device history record (dhr) shows that the reported component used in the previous surgery, when released for use, met design and manufacturing requirements.There was no non-conforming material report (ncmr) associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device 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 the patient fractured medial tibial plateau.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 noncompliance with medical instructions incorrect implant selection, patient activities or trauma.There are multiple factors that may also contribute to an event that are outside the control of djo surgical.There were no findings during this evaluation that indicate the reported device was defective.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 PARTIAL KNEE
• Type of Device: EMPOWR PARTIAL KNEETM, TIBIAL BASEPLATE, NP, SIZE 1, LM-RL
• Manufacturer (Section D): ENCORE MEDICAL L. P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 11659510
• MDR Text Key: 245318682
• Report Number: 1644408-2021-00274
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00190446295105
• UDI-Public: (01)00190446295105
• Combination Product (y/n): N
• PMA/PMN Number: K191325
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

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
• Device Operator: Health Professional
• Device Model Number: 357-01-101
• Device Catalogue Number: 357-01-101
• Device Lot Number: 187Z1018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 73 YR