MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; KEELED GLENOID

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Loss of Range of Motion (2032)

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.Concomitant medical devices: 47x22 humeral head; 4.5 rep.Plate; 13 stem, 22434008.

Event Description

It was reported that the patient had shoulder pain and lack of mobility.Surgeon removed the whole existing tsa implants and implanted all new components to a rtsa.

Event Description

As reported, this 74 y/o male patient, who weighs 190-200 lbs.Had shoulder pain and lack of mobility.Initial implant date is unknown.The surgeon removed the whole existing tsa implants and implanted all new components to a rtsa.Devices will not be returned due to hospital policy.All available information has been reported at this time.

Manufacturer Narrative

Section h10: (h3) as reported, this 74 y/o male patient, who weighs 190-200 lbs.Had shoulder pain and lack of mobility.Initial implant date is unknown.The surgeon removed the whole existing tsa implants and implanted all new components to a rtsa.Devices will not be returned due to hospital policy.All available information has been reported at this time.Based on review of all available information, there is no evidence to suggest that the reported event is related to any design, manufacturing, or patient related issues.The cause of the pain, range of motion issue, and subsequent revision cannot be conclusively determined since the devices were not returned.The most likely cause is patient conditions.(h6) evaluation codes: 1994, 2993.Section h11: the following sections have corrected information: (b5) describe event or problem: as reported, this 74 y/o male patient, who weighs 190-200 lbs.Had shoulder pain and lack of mobility.Initial implant date is unknown.The surgeon removed the whole existing tsa implants and implanted all new components to a rtsa.Devices will not be returned due to hospital policy.All available information has been reported at this time.*no information provided in the following section(s): a4, a5, b6, b7, d4, d6, g5, g8, h4, h7.

• Brand Name: EQUINOXE
• Type of Device: KEELED GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9264678
• MDR Text Key: 164582254
• Report Number: 1038671-2019-00552
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR