MAUDE Adverse Event Report: ARTHREX, INC. HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Date 03/20/2019

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 a shoulder prothesis surgery had been performed on (b)(6) 2019.Since the glenosphere, part number: ar-9504s-04, lot: 18.00085 has loosened post-op, a revision surgery took place on (b)(6) 2019.The glenosphere was reused during revision surgery, only the humeral insert was replaced by ar-9503s-06, batch number 18.00858.Update swit, 01-apr-2019: the surgeon decided to fix the glenosphere again and not replacing it.

• Brand Name: HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• 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: 8526610
• MDR Text Key: 142333486
• Report Number: 1220246-2019-01039
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888867061316
• UDI-Public: 00888867061316
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K142863
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2019

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 Model Number: HUMERAL INSERT S/36 +6 TO FIT IN 36 CUP
• Device Catalogue Number: AR-9503S-06
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/18/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other