MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR PS KNEE; EMPOWR PS KNEETM FEMUR, NONPOROUS, 5L

Model Number	242-01-105
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to significantly poor bone quality, the medial condyle of the knee fractured post-operatively causing the femoral implant to dislodge.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as poor bone quality and knee fracture.The previous surgery and the surgery detailed in this event occurred 35 days apart.The healthcare professional indicated there was a serious risk to the patient and 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 #242-01-105, empowr ps kneetm femur, nonporous, 5l which documents out of 12 parts lot, 1 part was rejected and scrapped due to part moved in fixture.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 poor bone quality and knee fracture.There were no findings during this evaluation that indicate the reported devices were defective.No information was submitted with the complaint regarding preexisting 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 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 if it becomes available.
Additional Manufacturer Narrative
The reason for this revision surgery was reported as poor bone quality and knee fracture.The previous surgery and the surgery detailed in this event occurred 35 days apart.The healthcare professional indicated there was a serious risk to the patient and 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#: 242-01-105, empowr ps kneetm femur, nonporous, 5l which documents out of 12 parts lot, 1 part was rejected and scrapped due to part moved in fixture.Second there was a nonconformance associated with the concomitant part#: 352-01-105, djo empowr kneetm, universal bp, np 5l which documents out of 20 parts lot, 1 part was rejected and scrapped due to casting defect.All other items in the respective lot were 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 complaint was a revision surgery due to poor bone quality and knee 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 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 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 if it becomes available.

• Brand Name: EMPOWR PS KNEE
• Common Device Name: EMPOWR PS KNEETM FEMUR, NONPOROUS, 5L
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• Manufacturer Contact: kiersten soderman ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 13079038
• Report Number: 1644408-2021-01476
• Device Sequence Number: 11800676
• Product Code: JWH
• UDI-Device Identifier: 00888912171755
• UDI-Public: (01)00888912171755
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160342
• 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,Followup
• Report Date (Section B): 01/31/2022

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: 09/17/2026
• Device Model Number: 242-01-105
• Device Catalogue Number: 242-01-105
• Device Lot Number: 858T1207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/29/2021; 12/29/2021
• Initial Report FDA Received Date: 12/23/2021
• Supplement Report FDA Received Date: 01/24/2022; 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 346-12-705 LOT 435V1008.; 352-01-105 LOT 297V1064.; 354-10-040 LOT 103Y1082.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 93 KG