MAUDE Adverse Event Report: ENCORE MEDICAL L.P DJO SURGICAL; RSP BASEPLATE, 30MM, W/P2 COATING

Catalog Number	508-32-204
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	05/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery due to dissociation.
Additional Manufacturer Narrative
The agent reported, "the patient fell and the baseplate pulled out of the bone.The glenoid components and the poly were removed and replaced with a humeral head and hemi adaptor.Female 80." the previous surgery and the surgery detailed in this event occurred 2 years, 6 months, 3 days apart.Item number: 508-32-204 "item description: rsp baseplate, 30mm, w/p2 coating " lot#: 769p2941 part revision: n product type: shoulder manufacture date: 27-sep-2023 expiration date: 05-sep-2029.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.If additional information regarding the reported event 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 defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.Root cause: the root cause of this complaint was a revision surgery due to the patient experiencing a fall, resulting in baseplate pull-out from the bone.There are multiple factors that may contribute to an event 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) show that the reported components used in the previous surgery, when released for use, met design and manufacturing requirements.There was a (ncmr# (b)(4) associated with the concomitant part # 508-32-103, which documents that out of 45 parts in the lot (864c6157), 1 part was rejected due to major dings/scratches on the polished surface.The rejected part was scrapped as material could not be reworked and was not released for use.All other items in the lot met 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.Complaint history: customer complaint history of the reported device(s) showed no present trends or ongoing issues that need review.

• Brand Name: DJO SURGICAL
• Common Device Name: RSP BASEPLATE, 30MM, W/P2 COATING
• 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: 25311006
• Report Number: 1644408-2026-00996
• Device Sequence Number: 10511733
• Product Code: KWS
• UDI-Device Identifier: 00888912144391
• UDI-Public: 00888912144391
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K112069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/27/2026

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: 508-32-204
• Device Lot Number: 769P2941
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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: 506-03-114 LOT. 831C2326; 506-03-114 LOT. 831C2438; 506-03-114 LOT. 831C2457; 506-03-122 LOT. 833C2099; 508-32-103 LOT. 864C6157; 509-02-032 LOT. 951W2246
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female