MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; DISC ULNA X-SMALL E+ BEARING KIT

Catalog Number	540-01-005
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Joint Laxity (4526); Metal Related Pathology (4530)
Date of Event	06/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported as, revision surgery: "the bushing had worn down-and metallosis".The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.Item number: 540-01-005.Item description: disc ulna x-small e+ bearing kit.Lot number: unknown.Part revision: na.Product type: discovery elbow.Manufacture date: unknown.Expiration date: unknown.This investigation is limited in scope as only partial information was provided to djo surgical - austin for review.The revised items were not returned for examination and the item and or lot numbers were not provided.To adequately investigate this event, the part and lot numbers are necessary.If this 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.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.
Event or Problem Description
Revision surgery - due to the bushing had worn down-and metallosis.

• Brand Name: DJO SURGICAL
• Common Device Name: DISC ULNA X-SMALL E+ BEARING KIT
• 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
• MDR Report Key: 25772734
• Report Number: 1644408-2026-01322
• Device Sequence Number: 10358557
• Product Code: JDC
• UDI-Device Identifier: 00190446254560
• UDI-Public: 00190446254560
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K090473
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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: 540-01-005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 07/09/2026
• 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: Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female