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

Catalog Number 9999

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Joint Dislocation (2374)

Event Date 01/09/2023

Event Type  Injury  

Event Description

It was reported via clinical study that the 78 yo female patient has experienced a dislocation that was revealed via x-ray.There was no trauma.However, there was increasing pain with movement only.The date of event onset is (b)(6) 2023.The patient was revised on (b)(6) 2023.The outcome was last known as resolved.

Manufacturer Narrative

After further review of additional information received the following sections g3, g6, h2, h3 and h6 have been updated accordingly.(h3) it was reported via clinical study that the 78 yo female patient has experienced a dislocation that was revealed via x-ray.There was no trauma.However, there was increasing pain with movement only.The date of event onset is (b)(6) 2023.The patient was revised on (b)(6) 2023.The outcome was last known as resolved.The case report form indicates this event is possibly not related to device and unlikely related to procedure.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design or manufacturing issues.The cause of the dislocation and subsequent closed reduction cannot be conclusively determined; however, it is most likely related to the patient¿s underlying condition and the result of loosened supporting ligaments and muscles, which allowed for dislocation occurring due to the significant ligament reconstruction.

• Brand Name: EQUINOXE
• 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 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 17079916
• MDR Text Key: 316697843
• Report Number: 1038671-2023-01273
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/23/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 10/23/2023
• 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
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White