MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; HUMERAL HEAD SHORT, 50MM (BETA)

Model Number 314-13-14

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 10/28/2021

Event Type  Injury  

Event Description

Approximately 8 yrs post an anatomic tsa, this (b)(6) male patient is status post removal of a loose glenoid component and conversion to a hemiarthroplasty was completed on (b)(6) 2020 (need mdr report#).Patient had reported increased pain and failure of bone graft to incorporate in the glenoid.Noted during this implantation - there was a large central contained lesion in the glenoid, glenoid fixation not possible.Defect was bone grafted and implanted back to a stable surface.On (b)(6) 2021, this patient presented with a painful failed hemiarthroplasty.On (b)(6) 2021, this patient was revised and was converted to a hemiarthroplasty and reported the humeral stem was retained.The study reported the surgery date as the ¿resolution¿ date.The case report form indicates this event is possibly related to devices and definitely related to the procedure.This event report was received through clinical data collection activities.

Manufacturer Narrative

Pending evaluation.Concomitant device(s): equinoxe replicator plate 4.5mm o/s, cn: 300-10-45, sn: unknown.

Event Description

Approximately 8 yrs post an anatomic tsa, this 56 y/o male patient had an anatomic revision due to glenoid loosening.Defect was bone grafted and implanted back to a stable surface.

Manufacturer Narrative

Section h10: (h3) the revision reported was likely the result of both patient conditions and an insufficient bond between the cage glenoid and the bone, which led to aseptic (non-infected) glenoid loosening.However, this cannot be confirmed as the devices and pre-revision x-rays were not available for evaluation.Section h11: *the following sections have corrected information: (b5) describe event or problem: approximately 8 yrs post an anatomic tsa, this 56 y/o male patient had an anatomic revision due to glenoid loosening.Defect was bone grafted and implanted back to a stable surface.(d4) catalog number: 314-13-14, serial number: (b)(6), expiration date: 13-feb-2018, unique identifier (udi) #: (b)(4) (d6a) if implanted, give date: (b)(6) 2013 (d6b) if explanted, give date: (b)(6) 2021 (d11) concomitant device(s): 300-10-15, 2674888 - equinoxe replicator plate 1.5mm o/s 300-20-02, 2604116 - equinox square torque define screw drive kit 310-02-53, 2392928 - equinoxe, humeral head tall, 53mm (beta) (g4) pma/510(k)number: k113309.

• Brand Name: EQUINOXE
• Type of Device: HUMERAL HEAD SHORT, 50MM (BETA)
• 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: 12900381
• MDR Text Key: 283494537
• Report Number: 1038671-2021-00643
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 10885862172716
• UDI-Public: 10885862172716
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/13/2018
• Device Model Number: 314-13-14
• Device Catalogue Number: 314-13-14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 126 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White