MAUDE Adverse Event Report: EXACTECH, INC. UHMWPE POST AUG GLENOID LARGE, RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	314-02-34
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Laxity (4526)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 300-62-02, 6400696 - stemless humeral comp integrip, cage, size 2.310-62-47, 6160816 - stemless humeral head 47mm x 15mm x beta.
Event or Problem Description
As reported, this 71 year old, female patient had right tsa on (b)(6) 2020.Over time, per the surgeon, the patient's rotator cuff deteriorated and the instability led to the loosening of the glenoid component.The patient was revised on 7/14/2022.There was no reported device breakage or surgical delay/prolongation.The patient was last known to be ins table condition following the event.The device is not returning per hospital policy.
Additional Manufacturer Narrative
H3: the revision reported in was likely the result of aseptic glenoid loosening secondary to contributions from shoulder instability and rotator cuff failure.However, this cannot be confirmed as the explanted devices were not available for evaluation and radiographs were not provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected information.The following sections were corrected: b1, b2, f10 (remove erroneous entries on initial report), h6: health effects-all, investigation findings and investigation conclusion.The revision reported was likely the result of aseptic glenoid loosening secondary to contributions from shoulder instability and rotator cuff failure.However, this cannot be confirmed as the explanted devices were not available 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.

• Brand Name: UHMWPE POST AUG GLENOID LARGE, 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: kate jacobson ; 2320 nw 66th ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 15178284
• Report Number: 1038671-2022-00892
• Device Sequence Number: 17709654
• Product Code: KWS
• UDI-Device Identifier: 10885862175113
• UDI-Public: 10885862175113
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K103419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2025

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 Expiration Date: 08/23/2020
• Device Model Number: 314-02-34
• Device Catalogue Number: 314-02-34
• 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: 07/21/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 11/25/2025
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 01/25/2023; 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2015
• 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 H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Female