MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE REPLICATOR PLATE 1.5MM O/S; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	300-10-15
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rep received a phone call from the surgeon explaining that he needed to revise a right shoulder replacement from a couple of years back.The anatomic replacement is now popping/sublaxing, so a revision to a reverse is necessary.Upon opening, the surgeon identified signs of infection, at which point the decision was made to do a 2 stage revision.The surgeon removed the implants and has put in one of exactech's shoulder spacers for the time being.Patient currently has an exactech shoulder spacer in-situ.Depending on extent of infection & damage to glenoid, surgeon is hoping to be revised to exactech reverse implants.Patient was last known to be in stable condition following the event.Devices are not returning.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 300-01-07 - equinoxe, humeral stem primary, press fit 7m.310-01-41 - equinoxe, humeral head short, 41mm (alpha).314-13-02 - equinoxe cage glenoid small, alpha.
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 subluxation and infection cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition.

• Brand Name: EQUINOXE REPLICATOR PLATE 1.5MM O/S
• 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: 15068223
• Report Number: 1038671-2022-00822
• Device Sequence Number: 5711951
• Product Code: KWT
• UDI-Device Identifier: 10885862079381
• UDI-Public: 10885862079381
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/02/2022

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 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: 06/29/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 07/20/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2018
• 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 Sex: Unknown