MAUDE Adverse Event Report: EXACTECH, INC. STEMLESS HUMERAL HEAD 47MM X 18MM X BETA; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO

Catalog Number	310-61-47
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Subluxation (4525)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's right shoulder was revised approximately 3 years post initial operation.Patient complained of pain and had a failed implant.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D10 - concomitants: (b)(6), 300-60-02 - stemless humeral comp laser cage, size 2, (b)(6), 314-13-13 - equinoxe cage glenoid medium, beta, (b)(6), 319-01-32 - steinmann pin sterile 3.2mm x 178mm, (b)(6), 531-78-20 - shouldr gps hex pins kit, 09004321074, (b)(6) - gps implant kit v2.H3: customer has indicated that the product is in process of being returned for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b7.The following sections were corrected: b5, h6 - health effect - clinical code, medical device problem code, component code.
Event or Problem Description
It was reported that this patient's shoulder was revised approximately 3 years post initial operation.Patient complained of pain and had a failed implant.It was determined that there was a rotator cuff tear with joint subluxation.Patient was last known to be in stable condition following the event.

• Brand Name: STEMLESS HUMERAL HEAD 47MM X 18MM X BETA
• Common Device Name: PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 21435972
• Report Number: 1038671-2025-01136
• Device Sequence Number: 4683786
• Product Code: PKC
• UDI-Device Identifier: 10885862537119
• UDI-Public: 10885862537119
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/30/2025

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: 310-61-47
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 07/26/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• 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: SEE H11
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 103 KG