MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; EMPOWR PARTIAL KNEETM, TIBIAL INSERT, SIZE 1, 8MM

Catalog Number	347-08-701
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Implant Pain (4561)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to pain and suspected infection.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
See d3, d4 expiration date, g1, h4, h6, and h11.The agent reported "(patient was experiencing pain, surgeon suspected infection)".The previous surgery and the surgery detailed in this event occurred 2 years and 2 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.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 an ncmr#(b)(6) associated with the concomitant part #247-01-103, empowr partial kneetm, femur, np, size3, lm-rl which document that out of 8 parts lot 2 parts were rejected due to burns on non polish area surface of condyle.Later, the rejected parts were reworked and accepted after proper justification.All other items in the 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 an infection and pain.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.

• Brand Name: DJO SURGICAL
• Common Device Name: EMPOWR PARTIAL KNEETM, TIBIAL INSERT, SIZE 1, 8MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENOVRE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 20378162
• Report Number: 1644408-2024-01512
• Device Sequence Number: 14401729
• Product Code: HSX
• UDI-Device Identifier: 00190446294269
• UDI-Public: 00190446294269
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 12/05/2024

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: 07/08/2025
• Device Catalogue Number: 347-08-701
• Device Lot Number: 163Z1016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2020
• 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: 247-01-103 LOT: 153Z1016.; 357-01-101 LOT: 187Z1020.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female