MAUDE Adverse Event Report: EXACTECH, INC. RS GLENOID PLATE SUP AUG, 10 DEG; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	320-15-02
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Unspecified Infection (1930); Septic loosening (4884)
Date of Event	04/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial reverse total shoulder replacement on the left side.Subsequently, the patient experienced loosening secondary to an infection in the left shoulder.As a result, approximately 2 months post-surgery, the patient underwent a revision.Patient was last known to be in stable condition following the event.No further impact to the patient was reported.No additional information is available at this time.
Additional Manufacturer Narrative
D10: concomitants: unknown competitor's stem, b271729 320-08-42 glenosphere exp 42mm +4mm offset, b415390 320-15-05 eq rev locking screw, b086539 320-20-30 - eq rev compress screw lck cap kit, 4.5 x30mm, b186783 320-20-30 - eq rev compress screw lck cap kit, 4.5 x 30mm, b416051 320-20-34 - eq rev compress screw lck cap kit, 4.5 x 34mm, b231747 320-20-38 - eq rev compress screw lck cap kit, 4.5 x 38mm, b397434 321-52-07 - 3.2mm drill bit sterile.The reported event was unable to be confirmed due to limited information received from the customer.No device was returned for evaluation; further, photographs and/or radiograph images were not provided for review.Operative notes and/or medical records were not provided for review of usage/ technique.A definitive root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: d1/d2a/d2b, h6 mdr section codes updated/corrected: b the revision reported may be the result of the glenoid loosening and infection as reported.However, the series of events and contributing factors to each cannot be confirmed and any potential contributions from patient-related contributing factors to the event cannot be evaluated as no radiograph, images, or clinical information was provided.The reported details also state that a competitor humeral implant construct was implanted during the index surgery.This off label use could contribute to uneven loading and wear on the exactech glenoid leading to the reported loosening and sterile certificates were not able to be reviewed for these components.A review of the sterile certificates for the explanted exactech glenoid baseplate and locking screw components was performed and the sterile lots were accepted to the requirements.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: RS GLENOID PLATE SUP AUG, 10 DEG
• 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, INC.; 2320 nw 66th ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th ct; gainesville, FL 32653
• MDR Report Key: 21972241
• Report Number: 1038671-2025-01981
• Device Sequence Number: 12880651
• Product Code: KWS
• UDI-Device Identifier: 10885862186676
• UDI-Public: 10885862186676
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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 Catalogue Number: 320-15-02
• 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: 04/27/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 11/26/2024
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male