MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; SHELL, BIPOLAR, MODULAR, ENCORE, SIZE52

Catalog Number	412-02-052
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery - due to bipolar shell came apart.
Additional Manufacturer Narrative
The agent reported, "bipolar shell came apart.M/86." the previous surgery and the surgery detailed in this event occurred 12 days apart.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.There was ncmr# (b)(4) associated with the main part # 412-02-052, shell, bipolar, modular, encore, size52, which documents that out of a 226-part lot, (b)(4) parts were rejected due to contamination with hydroxyapatite (ha) nano.1 part coated with ha nano was mistakenly cleaned with other cocr parts, contaminating them with ha').Later, the rejected parts were recleaned and accepted after proper justification.Ha coating enhances biological fixation of implants by promoting bone growth on the implant surface.It does not affect mechanical strength, geometry, or structural integrity.Therefore, ha cross-contamination on cocr components would not cause or contribute to a bipolar shell separating 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 due to the bipolar shell coming apart.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.

• Brand Name: DJO SURGICAL
• Common Device Name: SHELL, BIPOLAR, MODULAR, ENCORE, SIZE52
• 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: 24424090
• Report Number: 1644408-2026-00085
• Device Sequence Number: 6052277
• Product Code: KWY
• UDI-Device Identifier: 00888912077439
• UDI-Public: 00888912077439
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K953510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 02/23/2026

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: 412-02-052
• Device Lot Number: 000C1160
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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: 402-03-282 LOT: 6113510.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male