MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET

Model Number	320-02-38
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation: concomitant medical products: poly 308-10-05, 117771015 - large prox body +0, 320-10-00, 11172435 - equinoxe reverse tray adapter plate tray +0, 306-15-01, 129783001 - hrp screw.
Event or Problem Description
As reported, a (b)(6) male original shoulder implant dislocated.The surgeon tried to do a closed reduction on the patient and was unsuccessful, therefore the patient received a revision of the right hrp with a smaller size so the joint could be reduced.Revised the glenosphere from a 38 +4 to just a 38 and revised the proximal body from a large to an extra small.Patient was last known to be in stable condition following the event.Devices are available for return.,.Revised the glenosphere from a 38 +4 to just a 38 and revised the proximal body from a large to an extra small.Patient was last known to be in stable condition following the event.Devices are available for return.
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 the dislocation and subsequent revision cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament re-construction.

• Brand Name: EQUINOXE
• Common Device Name: RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 10152533
• Report Number: 1038671-2020-00303
• Device Sequence Number: 13994362
• Product Code: KWT
• UDI-Device Identifier: 10885862186751
• UDI-Public: 10885862186751
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110708
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 320-02-38
• Device Catalogue Number: 320-02-38
• Device Lot Number: 159261005
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 53 YR