MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; PRESERVE STEM 10MM

Model Number	300-30-10
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this (b)(6) male patient's right shoulder was revised due to loosening.The patient's preserve stem appeared to be loose at time of revision.Surgeon removed existing exactech implants and replaced them with a 42+4 glenosphere.Patient was last known to be in stable condition following the event.Devices are not available for return.
Additional Manufacturer Narrative
Pending evaluation.Concomitant device(s): 320-06-38, 7063923 - glenosphere 38mm.320-10-00, 7052245 - equinoxe reverse tray adapter plate tray +0.320-38-00, unknown - equinoxe reverse 38mm humeral liner +0.320-06-38, 7063923 - glenosphere 38mm.
Additional Manufacturer Narrative
Section h10: (h3) the revision reported may have been the result of an insufficient bond between the humeral stem and the bone, which led to aseptic (non-infected) humeral loosening.However, this cannot be confirmed as the devices were not returned for evaluation and pre-revision x-rays were unable to be obtained.Section h11: the following sections have corrected information: (h6) component code: 7455, part/component/sub-assembly term not applicable.

• Brand Name: EQUINOXE
• Common Device Name: PRESERVE STEM 10MM
• 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: 14631518
• Report Number: 1038671-2022-00646
• Device Sequence Number: 3738761
• Product Code: KWT
• UDI-Device Identifier: 10885862515780
• UDI-Public: 10885862515780
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K162726
• 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): 01/04/2023

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: 300-30-10
• Device Catalogue Number: 300-30-10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• 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; Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 94 KG