MAUDE Adverse Event Report: ENCORE MEDICAL L.P. AR, SMALL SOCKET INSERT, 36MM NEUTRAL +4 EPLUS; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	509-02-436
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Joint Dislocation (2374); Joint Laxity (4526); Implant Pain (4561)
Date of Event	05/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Rivision surgery - due to dislocation, instability and pain.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
See d4 expiration date, h4 and h11.The reason for this revision surgery, the agent reported "(dissociated poly.Unstable and pain)".The previous surgery and the surgery detailed in this event occurred 1 year and 10 months apart.This evaluation is limited in scope as the items associated with this investigation were not returned to djo surgical - austin for review.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 the reported devices were defective.The surgeon performed this procedure to remedy the patient's condition.No further action is deemed necessary.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 main part #: 509-02-436, ar, small socket insert, 36mm neutral +4eplus which documents that out of (b)(4) parts lot 1 part was scrapped due to engraving not legible.Second, there was an ncmr #: 63663 associated with the concomitant part #: 508-36-101, glenoid, head w/retaining screw, rsp, 36 mm, neutral which document that out of (b)(4) parts lot 3 parts were rejected due to machine lines on polished articulating surface.Later, the rejected parts were reworked and accepted after proper justification.All other item 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.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 a revision surgery due to dissociation, instability and pain.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 event.There are multiple factors that may also contribute to an event that are outside the control of djo surgical such as poor bone density, prolonged overhead activities, inadequate soft tissue support, patient activities or trauma.
Event or Problem Description
Revision surgery - due to dissociation, instability and pain.

• Brand Name: AR, SMALL SOCKET INSERT, 36MM NEUTRAL +4 EPLUS
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19495034
• Report Number: 1644408-2024-00899
• Device Sequence Number: 15593188
• Product Code: KWS
• UDI-Device Identifier: 00190446257615
• UDI-Public: 00190446257615
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K172351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• 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): 07/30/2024

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: 05/04/2024
• Device Catalogue Number: 509-02-436
• Device Lot Number: 957W1063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2019
• 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: 831C2129.; 506-03-118 LOT: 832C1925.; 506-03-126 LOT: 834C1978.; 506-03-126 LOT: 834C1987.; 508-36-101 LOT: 869C3544.; 533-08-108 LOT: 926W1688.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male