MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; REVERSE 42MM GLENOSPHERE

Model Number	320-01-42
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pending evaluation.Concomitant medical products: 320-15-05, 7134580 - eq rev locking screw; 320-42-00, s269246 - equinoxe reverse 42mm humeral liner +0.
Event or Problem Description
As reported, six days after initial left tsa, this (b)(6) old male patient was revised due to the post op scan revealing that the sphere was not properly seated.Surgeon implanted the glenosphere incorrectly.The same sized components were used.Patient was last known to be in stable condition following the event.Devices will not be retuning.
Additional Manufacturer Narrative
(h3) the revision reported was likely the result of cross-threading the glenosphere locking screw into the baseplate and/or not properly aligning the glenosphere on the baseplate, which resulted in incomplete seating of both the glenosphere locking screw and glenosphere.However, this cannot be confirmed as the devices were not returned for evaluation.Section h11: the following sections have corrected information: h6: medical device problem code: 2923 - device dislodged or dislocated component code: 568 - screw.

• Brand Name: EQUINOXE
• Common Device Name: REVERSE 42MM GLENOSPHERE
• 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: 13858827
• Report Number: 1038671-2022-00272
• Device Sequence Number: 990940
• Product Code: KWT
• UDI-Device Identifier: 10885862086396
• UDI-Public: 10885862086396
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063569
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2022

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: 320-01-42
• Device Catalogue Number: 320-01-42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 03/23/2022
• Supplement Report FDA Received Date: 08/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 131 KG