MAUDE Adverse Event Report: EXACTECH, INC. 7X80MM DISTAL STEM MODULAR CEMENTED; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number	308-01-07
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total shoulder replacement on the left side.Subsequently, the patient experienced aseptic humeral loosening.Patient presented with pain and arm swelling.As a result, approximately 7 years after initial replacement, the patient still has been experiencing pain but has started taking tramadol which has helped and was administered a brace.No further impact to the patient was reported.No other information is available.
Additional Manufacturer Narrative
(d10) concomitant devices: 320-36-10 - 145-deg pe 36mm const hum liner +0: (b)(6), 320-10-00 - equinoxe rev tray adapter plate tray +0: (b)(6), 320-32-36 - exp glenosphere, 36mm, for small reverse: (b)(6), 320-35-02 - small superior augment glenoid plate: (b)(6), 308-05-19 - distal fixation ring ha 19.5: (b)(6), 308-09-00 - small prox body +0: (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.
Additional Manufacturer Narrative
The adverse event reported may be the result of the humeral loosening as reported.However, the loosening cannot be confirmed and any potential contributions from manufacturing, user, or patient-related contributing factors to the event cannot be evaluated as the devices remain implanted and no radiographs or clinical information was provided.H6: corrected investigation clinical codes.

• Brand Name: 7X80MM DISTAL STEM MODULAR CEMENTED
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 21647338
• Report Number: 1038671-2025-01628
• Device Sequence Number: 12653538
• Product Code: PHX
• UDI-Device Identifier: 10885862267887
• UDI-Public: 10885862267887
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K143659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2025

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: 06/21/2026
• Device Catalogue Number: 308-01-07
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/20/2025
• Date Device Manufactured: 06/21/2016
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Race: Black Or African American