MAUDE Adverse Event Report: EXACTECH, INC. UHMWPE POST AUG GLENOID MEDIUM, LEFT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-02-23
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); Aseptic loosening (4883)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(d10) concomitant devices: 300-01-09 - eq humeral stem primary, press fit 9mm: (b)(6).310-01-44 - eq humeral head short, 44mm (alpha): (b)(6).300-10-45 - replicator plate 4.5mm o/s: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
Approximately 12 year(s) and 7 day(s) post-operative of a left rtsa, it was reported via clinical study that the patient experienced aseptic glenoid loosening with gradual increased pain, decreased function, and loosening on x-ray.The patient underwent a standard total revision with the reported removal of the replicator plate, torque screw, humeral head, and glenoid components.Additionally, the patient was revised to a hemiarthroplasty and the outcome of this event is considered resolved.The case report form indicates that this event is unlikely related to the device(s) and/or to the procedure.This was reported through clinical trial study data collection activities, no device return is anticipated, and no other information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: h6.Mdr section codes updated/corrected: b, c, d, e, g.The revision reported may be the result of the glenoid loosening as reported.However, the failure cannot be confirmed as no relevant clinical information, images, or radiographs were provided.Potential contributions of patient or user-related issues to the event cannot be determined from the reported information.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: UHMWPE POST AUG GLENOID MEDIUM, LEFT
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21428194
• Report Number: 1038671-2025-01123
• Device Sequence Number: 20004599
• Product Code: KWS
• UDI-Device Identifier: 10885862175069
• UDI-Public: 10885862175069
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K103419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 02/08/2016
• Device Catalogue Number: 314-02-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 07/03/2025
• Date Device Manufactured: 02/10/2011
• 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: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White