MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; DISC CONDYLE KIT W/ HEXALOBULA

Catalog Number	540-00-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The agent reported, "total elbow poly exchange." the previous surgery and the surgery detailed in this event occurred 1 year, 6 months, 14 days apart.The actual length of in-vivo for the items listed is unknown as the original surgery date was not provided or could be established.This evaluation is limited in scope as the item(s) associated with this investigation was not returned to djo surgical - austin for examination.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.A review of the device history record(s) shows that the reported component(s) used in the previous surgery met design and manufacturing requirements at the time of release for use.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.Customer complaint history of the reported device(s) showed no present trends or ongoing issues that need review.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.The root cause of this complaint was revision surgery for total elbow poly exchange.No information regarding the patient's pre-existing conditions or any activities the patient was involved in that may have contributed to the event was submitted to the complaint.There are multiple factors that may contribute to an event beyond djo surgical's control.
Event or Problem Description
Revision surgery - total elbow poly exchange, unknown reason.
Additional Manufacturer Narrative
This supplemental report has been created to updated h10 and h11 complaint has been evaluated and is similar to report number 1644408-2019-00412 ; 114800, s800 - revision surgery, revision surgery if additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.

• Brand Name: DJO SURGICAL
• Common Device Name: DISC CONDYLE KIT W/ HEXALOBULA
• 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: stacey bonnell ; 9800 metric blvd; austin, TX 78758 ; 5128346313
• MDR Report Key: 24310262
• Report Number: 1644408-2026-00219
• Device Sequence Number: 17538849
• Product Code: JDC
• UDI-Device Identifier: 00190446137610
• UDI-Public: 00190446137610
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051975
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• 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): 04/02/2026

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 Catalogue Number: 540-00-000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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: Other
• Patient Age: 66 YR
• Patient Sex: Female