MAUDE Adverse Event Report: ENCORE MEDICAL L.P. DJO SURGICAL; RSP MONOBLOCK SOCKET INSERT, 44MM +4MM, SEMICONSTRAINED, HXE-PLUS

Catalog Number	509-01-444
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Dislocation (2374); Joint Laxity (4526)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient required revision surgery to treat instability and possible infection.
Additional Manufacturer Narrative
The agent reported "(revised to treat instability (possible infection))".The previous surgery and the surgery detailed in this event occurred 5 months and 2 weeks apart.This evaluation is limited in scope as limited information was provided to djo surgical - austin for review.If information regarding cultures identified in the infection, the severity of the infection or any other relevant 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.There were no findings during this evaluation that indicate that the reported devices were the source or had a direct connection with the patient's infection.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.First, there was a nonconformance associated with the concomitant part #508-44-101, 44mm rsp glen hd +8mm which documents that out of 10 parts lot, 1 item was rejected and scrapped during cmm operation.Second, there was an ncmr#74890 associated with the concomitant part #506-03-118, screw, locking bone, rsp, 5x18 which document that out of 93 parts lot, 1 item was rejected due to different lot number.Later, the rejected part was returned to vendor.Third, there was a nonconformance associated with the same part which documents that out of 93 parts lot, 1 item was rejected during flow bench verification.All other items in the lot were met with fit, form and function requirements.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 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 was a revision surgery due to infection and instability.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 possible infection or inhibited the patient's immune system.There are multiple factors that may contribute to an infection that are outside the control of djo surgical.

• Brand Name: DJO SURGICAL
• Common Device Name: RSP MONOBLOCK SOCKET INSERT, 44MM +4MM, SEMICONSTRAINED, HXE-PLUS
• 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: 23353647
• Report Number: 1644408-2025-01549
• Device Sequence Number: 8806979
• Product Code: KWS
• UDI-Device Identifier: 00888912144681
• UDI-Public: 00888912144681
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 12/18/2025

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: 12/06/2025
• Device Catalogue Number: 509-01-444
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/08/2025
• 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: 506-03-118 LOT CODE 832C2429; 506-03-126 LOT CODE 834C2482; 506-03-130 LOT CODE 835C2397; 508-32-204 LOT CODE 769P3520; 508-44-101 LOT CODE 877C1233
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male