MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
Medical Device Problem Codes	Incorrect Measurement (1383); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the agent present during the surgery understood there was a problem when the surgeon inserted the stem (implant), it seemed to not fit properly , the stem was not progressing as expected, he removed it and saw it was in fact a size 12 that has been packaged in an implant box size 11.There was no averse event due to the delayed.The initial indication for patient's tsa was shoulder arthritis secondary to rotator cuff tear.Photo received.The device will be return.
Additional Manufacturer Narrative
H3: based on the available information review, there is no definitive root cause identified.The available data demonstrates that the implants themselves and the packaging and labeling were processed appropriately.It is possible that a product mix-up occurred at the order pulling stage for these products during the packaging step, although this cannot be definitively determined.No further mislabeled products within related lot numbers/work orders were found and therefore there is no indication of further devices being impacted.H6: health effect - clinical code, medical device problem code, investigation finding, investigation conclusion.
Additional Manufacturer Narrative
H3: based on the available information review, there is no definitive root cause identified.The available data, reviewed in (b)(4), demonstrates that the implants themselves and the packaging and labeling were processed appropriately.The most probable place of a product mix-up is at the order pulling stage for these products in the packaging department, although cannot be definitively determined.

• Brand Name: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• 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 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 17858373
• Report Number: 1038671-2023-02434
• Device Sequence Number: 6183655
• Product Code: KWS
• UDI-Device Identifier: 10885862079312
• UDI-Public: 10885862079312
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2024

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 Model Number: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM
• Device Catalogue Number: 300-01-11
• Device Lot Number: 02012385
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 04/15/2024; 10/11/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 04/21/2024; 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• 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
• Patient Sex: Unknown