MAUDE Adverse Event Report: EXACTECH, INC. STEMLESS HUMERAL HEAD 41MM X 13MM X ALPHA; PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO

Catalog Number	310-62-41
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's left shoulder was revised.The revision was due to a failed rotator cuff and worn polyethylene.Patient also had metallosis.Patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
D10 concomitant: 300-62-01 - stemless hum comp integrip, cage, size 1: (b)(6).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.
Event or Problem Description
It was reported that this patient's left shoulder was revised.The revision was due to a failed rotator cuff and worn polyethylene.Patient also had metallosis.Patient was last known to be in stable condition following the event.Additional information was received indicating that the patient had poly disassociation.It was also noted that pain had started 2 month prior to the revision surgery.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b5, h6: component code.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated/corrected: b3 h6.Mdr section codes updated/corrected: b, c, d.The revision reported was likely the result of rotator cuff deficiencies and prosthesis wear of the polyethylene component as reported.Proximal humeral component migration relative to the glenoid likely caused eccentric loading of the glenoid component, leading to full-thickness polyethylene wear and fracture.However, rotator cuff failure and the series of events cannot be confirmed and potential contributions of user or patient-related considerations to the event could not be assessed as the devices were not returned for evaluation and radiographs were 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 corrected: h1 type of reportable event: serious injury if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: STEMLESS HUMERAL HEAD 41MM X 13MM X ALPHA
• 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: 21733682
• Report Number: 1038671-2025-01695
• Device Sequence Number: 15703809
• Product Code: PKC
• UDI-Device Identifier: 10885862556110
• UDI-Public: 10885862556110
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup,Followup
• Report Date (Section B): 08/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 310-62-41
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 08/20/2025; 08/20/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 07/02/2025; 08/21/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2019
• 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: Female
• Patient Weight: 80 KG