MAUDE Adverse Event Report: EXACTECH, INC. MOLDED CAGE GLENOID SMALL, ALPHA; PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 314-23-02

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 08/24/2023

Event Type  Injury  

Manufacturer Narrative

Pending investigation.D10: a082786 300-01-09 - equinoxe, humeral stem primary, press fit 9mm; 6418254 310-01-38 - equinoxe, humeral head short, 38mm (alpha) 7288542 300-10-45 - equinoxe replicator plate 4.5mm o/s.

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2023.The patient presented on (b)(6)2023 and (briefly describe adverse event) had an initial dislocation while drinking that spontaneously reduced in car.Had pain/instability since and patient reports an unexplained increased pain and decreased function.Ct scan ordered; components are well placed, possible subscapularis tear.The case report form indicates that this event is definitely not to device, possibly related to procedure.Outcome: continuing.

Event Description

As reported, the patient had an initial right tsa on (b)(6) 2023.The patient presented on (b)(6) 2023 with pain.Had pain/instability since and patient reports an unexplained increased pain and decreased function.Ct scan ordered; components are well placed, possible subscapularis tear.The case report form indicates that this event is definitely not related to device and possibly related to procedure.The outcome of this event is resolved by standard total revision on (b)(6) 2024.

Manufacturer Narrative

(b5) corrected original description and added revision information.(d6b) added explant date.

• Brand Name: MOLDED CAGE GLENOID SMALL, ALPHA
• Type of Device: PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66th ct.; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 18109242
• MDR Text Key: 327886150
• Report Number: 1038671-2023-02736
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 314-23-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/16/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American