MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR PS KNEETM FEMUR, NONPOROUS, 11R; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	242-02-111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/30/2023
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 - mdr - significant adverse event/required intervention to prevent impairment/damage (revision).
Additional Manufacturer Narrative
Added d4 (expiration date), added h4 (device manufacture date).The agent reported "(the surgeon elected to use a "hoffman" style spacer because of the tibial bone loss and was unable to clear their prior infection.The spacer implants were removed and replaced with a new "hoffman" style component)".The previous surgery and the surgery detailed in this event occurred 2 years and 4 months apart.This evaluation is limited in scope as limited information was provided to djo surgical - austin for review.If information regarding cultures identified in the infection, the severity of the infection or any other relevant information is submitted at a future date, this investigation will be re-evaluated.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.There were no findings during this evaluation that indicate the reported devices were the source or had a direct connection with the patient's infection.Root cause: the root cause of this complaint was a revision surgery due to bone loss and infection.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 possible infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside the control of djo surgical.Containment: inventory containment is not required as there are no indications of a product or process issue affecting implant safety or effectiveness.The revision surgery was completed successfully.Device history records review: 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.First, there was a nonconformance associated with the concomitant part which document that out of (b)(4) parts lot 4 parts were rejected and scrapped during deburr and inspection process.Second, there was an ncmr associated with the concomitant part which document that out of (b)(4) parts lot, all the parts were rejected due to.005 perpendicularity feature not inspected, is was incorrect.Later, the rejected parts were reworked after proper justification.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.Complaint history: customer complaint history of the reported devices showed no present trends or on-going issues that are needing a review.

• Brand Name: EMPOWR PS KNEETM FEMUR, NONPOROUS, 11R
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758-5445
• MDR Report Key: 18213155
• Report Number: 1644408-2023-01681
• Device Sequence Number: 15108710
• Product Code: JWH
• UDI-Device Identifier: 00888912171915
• UDI-Public: 00888912171915
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 2023
• 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): 12/06/2023

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: 12/12/2023
• Device Catalogue Number: 242-02-111
• Device Lot Number: 874T1035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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: 346-10-711 , LOT 429V1003; 352-01-111 , LOT 303V1006; 354-10-065 , LOT 104Y1002
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male