MAUDE Adverse Event Report: EXACTECH, INC.; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

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

Patient Problem Failure of Implant (1924)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

Section h10: (h3) pending evaluation.(d10) concomitant device(s): 310-01-44: equinoxe, humeral head short, 44mm (alpha).300-10-15: equinoxe replicator plate 1.5mm o/s.

Event Description

As reported by the equinoxe shoulder study, the patient had an initial tsa on (b)(6) 2010 and revised on (b)(6) 2015 (refer to (b)(4).The patient presented on 07-oct-2019 with aseptic glenoid loosening - of the glenoid component implanted in 2010.The case report form indicates that this event is unlikely related to device and/or procedure.Outcome is continuing and rehabilitation until patient decides if she agree for revision surgery.Revision surgery was planned for spring 2020 but cancelled due to covid.Last postop visit (b)(4) 2023 patient manages well her status, therefore, revision surgery is still not organized at the moment.

Manufacturer Narrative

H3: the glenoid loosening reported may have been the result of deterioration of the bond between the glenoid component and the bone after being implanted for over 10 years, which led to aseptic (non-infected) loosening of the glenoid component.However, this cannot be confirmed because the component was not returned for evaluation.

• Brand Name: UNK
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18196984
• MDR Text Key: 328895462
• Report Number: 1038671-2023-02841
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K042021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 67 KG
• Patient Race: White