MAUDE Adverse Event Report: ENCORE MEDICAL LP DJO SURGICAL; ALTIVATE REVERSE MOD BASEPLATE AND TAPER KIT, 6.5MM NEUTRAL

Model Number	508-65-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation: the agent reported, "infection presented 3 weeks post op, pt required full removal, disinfection, and implant revision with same sized implants." the previous surgery and the surgery detailed in this event occurred 30 days.Item number: 508-65-000, item description: altivate reverse mod baseplate and taper kit, 6.5mm ne, lot#: 5008a1167, part revision: a, product type: shoulder, manufacture date: 06-dec-2024, expiration date: 26-nov-2029.This evaluation is limited in scope as limited information was provided to enovis surgical - austin for examination.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 were no findings during this evaluation that indicate that the reported device(s) was the source or had a direct connection with the patient's infection.Root cause: the root cause of this complaint was reported as an infection.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.Due to the short time between the original surgery and the revision, it is possible that the infection was acquired in the hospital (nosocomial).It is also possible that the patient was not compliant with post surgical instructions.There are multiple factors that may contribute to an infection that are outside of the control of enovis surgical.Containment: 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.Device history records review: a review of the device history records (dhr) confirmed that the reported components used in the previous surgery met all design and manufacturing requirements at the time of release.Two associated nonconforming material reports were identified: ncmr-78110 for part 506-04-118 and ncmr-74826 for part 506-04-114.Ncmr-78110 documented that four lots were missing required form 1000.3480.01 rev a from the work order router; all affected units (b)(4) total) were reworked and accepted following proper justification, with no scrap reported.Ncmr-74826 documented a 100% re-inspection of 782 units to verify that the screw size matched the outer packaging per rework instructions; all units were reworked and accepted with no adverse impact to performance or safety identified.All other items within the respective lots met fit, form, and function requirements.Additionally, the devices were confirmed to have undergone an acceptable sterilization process and were within their labeled expiration date at the time of the previous surgery.Complaint history: customer complaint history of the reported device(s) showed no present trends or ongoing issues that need review.
Event or Problem Description
Infection presented 3 weeks post op, pt required full removal, disinfection, and implant revision with same sized implants.

• Brand Name: DJO SURGICAL
• Common Device Name: ALTIVATE REVERSE MOD BASEPLATE AND TAPER KIT, 6.5MM NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL LP; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: stacey bonnell ; 9800 metric blvd.; austin, TX 78758 ; 8003219549
• MDR Report Key: 25130572
• Report Number: 1644408-2026-00879
• Device Sequence Number: 9326622
• Product Code: KWS
• UDI-Device Identifier: 00190446822837
• UDI-Public: 00190446822837
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K233481
• 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): 05/08/2026

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 Model Number: 508-65-000
• Device Lot Number: 5008A1167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2024
• 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: 506-04-114 5031A1177.; 506-04-118 5033A1002.; 506-04-130 5023A1039A.; 506-04-130 5039A1079.; 508-36-101 869C5040.; 509-01-436 390P1106.; 530-10-108 409T2130D.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male