MAUDE Adverse Event Report: EXACTECH, INC. LASER CAGE GLENOID L, 8 POST AUG, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	314-24-34
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	08/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, approximately 1 year and 2 months post the initial right tsa, the patient's subscap failed and they had to be converted to a reverse.All exactech implants were removed and replaced with a competitor's reverse implants.There was no reported breakage of a device or surgical delay/prolongation.The patient was last known to be in stable condition following the event.
Additional Manufacturer Narrative
Pending investigation.D10: (b)(6) 300-60-02 - stemless humeral comp laser cage, size 2.(b)(6) 310-61-50 - stemless humeral head 50mm x 19mm x beta.(b)(6) 319-01-32 - steinmann pin sterile 3.2mm x 178mm.(b)(6) 321-52-07 - 3.2mm drill bit sterile.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: h6 component code, type of investigation, investigation findings, investigation conclusions.The following sections were corrected: h6 problem code.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.
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.Pma 510k cannot be determined; device is unknown.Catalog number, udi number, serial number, expiration and manufactured dates unknown.The reason for the revision reported is likely due to rotator cuff failure as reported.However, the reported rotator cuff failure and prosthesis wear could not be confirmed from the provided information.Potential contributions of patient or user-related considerations to the event could not be assessed as the device was not returned and product images were not provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: LASER CAGE GLENOID L, 8 POST AUG, RIGHT
• 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 ; 3523771140
• MDR Report Key: 20168504
• Report Number: 1038671-2024-03356
• Device Sequence Number: 12513223
• Product Code: KWS
• UDI-Device Identifier: 10885862585400
• UDI-Public: 10885862585400
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K212356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 314-24-34
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: 08/06/2025; Not provided
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 08/20/2025; 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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: 63 YR
• Patient Sex: Male