MAUDE Adverse Event Report: ENCORE MEDICAL L.P. INSERT, 3D, DCM, SIZE7, 9MM, RT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	392-09-607
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to wearing / required intervention to prevent impairment/damage.
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
The reason for this revision surgery, the agent reported "(the reason for revision was the tib insert was worn out.F/75 implant with some tissue being return in a explant kit)." the previous surgery and the surgery detailed in this event occurred 10.1 years apart.The item associated with this investigation was returned on rma-976482 to djo surgical - austin for examination.It is confirmed that wear was the reason for the revision.The insert shows the top area of the medial surface with pitting and delamination.The revision 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 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 first complaint against lot number 59600360 across all failure code categories.A review of the device history record(s) shows 1 ncmr associated with the product for code v8/surface finish per drawing.Qty(b)(4) disposition rework, qty (b)(4) acceptable after rework.The devices were verified to have gone through an acceptable sterilization process.Work order (attached) shows lot 59600360, 20 pcs were released.The root cause of this complaint was a revision surgery due to a worn insert which is confirmed with the return of the item.It could be that bone and other matter invaded the articulating surfaces, which is the region that experienced the pitting and delamination, as seen the in the attached photos.Due to the damage across the articulating surfaces from pitting and delamination, measurements could not be recorded with confidence.There are other multiple factors that may have contributed to this event which are outside of the control of djo surgical.

• Brand Name: INSERT, 3D, DCM, SIZE7, 9MM, RT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: 18956386
• Report Number: 1644408-2024-00304
• Device Sequence Number: 4500643
• Product Code: JWH
• UDI-Device Identifier: 00888912120180
• UDI-Public: 00888912120180
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K020114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• 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): 06/21/2024

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: 05/28/2015
• Device Catalogue Number: 392-09-607
• Device Lot Number: 59600360
• 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: 05/23/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female