MAUDE Adverse Event Report: ENCORE MEDICAL L.P. EMPOWR/DJO SURGICAL; EMPOWR 3D KNEETM INS, 9R 12MM, VE

Catalog Number	342-12-709
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery, the agent reported "(doctor complete full revision of a previously implanted 3d knee (press fit).We are requesting implant kit so we can send back the poly and have further analyzing)".The previous surgery and the surgery detailed in this event occurred 4 years apart.This evaluation is limited in scope as the items associated with this investigation were not returned to djo surgical austin for review.The surgery was completed as intended and without incident.If additional information regarding the reported event 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 defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.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 were no non-conforming material reports (ncmr) associated with the products that may have contributed to the reported event.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 for this complaint was a revision of previously implanted press fit knee.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.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, inadequate soft tissue support, patient activities or trauma.
Event or Problem Description
Revision surgery due to dr.Complete full revision of a previously implanted 3d knee (pressfit).
Additional Manufacturer Narrative
See d1, d2a, d2b, d4, d9, g4, h3, h4 and h11.The reason for this revision surgery, the agent reported "(dr.Complete full revision of a previously implanted 3d knee (pressfit).We are requesting implant kit so we can send back the poly & have further analyzing.Male, 70.)." the previous surgery and the surgery detailed in this event occurred 4 years apart.The item associated with this investigation was returned on rma-e975938 dtd 2/12/24 to djo surgical - austin for examination.See attached photos, the insert shows some wear, damaged/broken tabs (most likely from being extracted) and the part/lot number is illegible.A cmm inspection could not be attempted due to the damaged tabs.Size verification: 2.817 +/- 015 actual 2.823 (acceptable).642 +/-.025 actual.638 (acceptable).The surgery was completed as intended and without incident.If additional information regarding the reported event 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 that the reported device(s) was defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are needing a review.This is the second complaint against this lot number.The previous component was not returned for examination.A review of the device history record(s) show that the reported component(s) used in the previous surgery, when released for use, met design and manufacturing requirements.There were no nonconforming material reports associated with the product(s) that may have contributed to the reported event.The device(s) was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Work order shows that 20 pcs.Were batched and 20 were released to stores.Oracle shows that all have been consumed.Nventory 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.The root cause of this complaint cannot be determined.The inspection that could be completed was found to be acceptable.The damage to the poly hinders further evaluation.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.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.

• Brand Name: EMPOWR/DJO SURGICAL
• Common Device Name: EMPOWR 3D KNEETM INS, 9R 12MM, VE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 18794354
• Report Number: 1644408-2024-00200
• Device Sequence Number: 6532143
• Product Code: FZX
• UDI-Device Identifier: 00888912167468
• UDI-Public: 00888912167468
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K143242
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 07/15/2024
• 2 Devices were Involved in the Event: 1 2

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: 03/24/2021
• Device Catalogue Number: 342-12-709
• Device Lot Number: 123T1012
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2016
• 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: 243-02-108 LOT: 287W1044; 342-12-709 LOT: 123T1012; 353-02-109 LOT: 204W1018; 353-02-109 LOT: 204W1018
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male