MAUDE Adverse Event Report: ARTHREX, INC. ECLIPSE TRUNION,41 MM TPS CTD; TOTAL SHOULDER ARTHROPLASTY SYSTEM

Model Number ECLIPSE TRUNION,41 MM TPS CTD

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that a glenoid component removal had to be performed as a revision surgery due to an aseptic loosening of the device.No further information received.Update 31-mar-2021: further information was received.X-rays and pictures were provided containing the part- and lot-no.Of all involved devices (ar-9105-01/lot 1246018, ar-9301-02/lot 2501252307, ar-9300-41cpc/lot 2501241206, cd-9341-16/1242003), which were primary implanted on the (b)(6) 2013.The date of incident was confirmed to be the (b)(6) 2021 although the patient has experienced the correspondingly large burden on her shoulders already for many years, but had to care for her severely disabled husband.After the husband passed away, the patient decided to have the operation.During the revision a filling with bone substitute cerament (hemi) was performed to treat the patient.

• Brand Name: ECLIPSE TRUNION,41 MM TPS CTD
• Type of Device: TOTAL SHOULDER ARTHROPLASTY SYSTEM
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 11642947
• MDR Text Key: 244738690
• Report Number: 1220246-2021-02872
• Device Sequence Number: 1
• Product Code: QHQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K183194
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/09/2021

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 Expiration Date: 09/30/2017
• Device Model Number: ECLIPSE TRUNION,41 MM TPS CTD
• Device Catalogue Number: AR-9300-41CPC
• Device Lot Number: 2501241206
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/09/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR