MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	300-10-15
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a couple of days after surgery, this 75 y/o female patient left shoulder originally had an exactech reverse shoulder implanted (approx.7 months ago), it became infected so the surgeon decided to take everything out and let it heal.Last week we used a trauma long stem and cta head.Unfortunately, the patients soft tissues didn¿t allow the cta head to be to proud and put pressure on the sutures superiorly.The surgeon used a size 7mm standard stem with a 38mm cta head to help reduced pressure on the soft tissues.The 7mm stem was cemented in.Patient was last known to be in stable condition following the event.Devices are not returning.First event stated is captured in 1038671-2022-00706 / case-(b)(4).
Additional Manufacturer Narrative
Concomitant device(s): 300-20-02, (b)(4) - equinox square define screw drive kit.306-01-08, (b)(4) - equinoxe, humeral long stem 8mm 175mm.310-22-47, (b)(4) - cta humeral head tall, 47mm.
Additional Manufacturer Narrative
Section h10: (h3) based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of surgical revision for pain cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and previous joint infection.

• Brand Name: EQUINOXE
• Common Device Name: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 3523771140
• MDR Report Key: 14841384
• Report Number: 1038671-2022-00740
• Device Sequence Number: 2351505
• Product Code: KWT
• UDI-Device Identifier: 10885862079381
• UDI-Public: 10885862079381
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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 Expiration Date: 02/09/2026
• Device Model Number: 300-10-15
• Device Catalogue Number: 300-10-15
• 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: 06/07/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Female