MAUDE Adverse Event Report: ARTHREX, INC. GLENOID, POLY WITH KEEL, SMALL; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number GLENOID, POLY WITH KEEL, SMALL

Device Problems Break (1069); Component Missing (2306)

Patient Problem Failure of Implant (1924)

Event Date 12/11/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that a eclipse with metal backed glenoid with poly was implanted.After 1 year an x-ray was done were the surgeon saw the glenoid piece was not as it should like.A revision total shoulder was done and the surgeon found the pe-liner glenoid was broken.Superior parts were absent and inferior part were still in place.The broken part was thrown away and the other pieces of the glenoid will be returned.No further information at the moment.Further questions asked.

• Brand Name: GLENOID, POLY WITH KEEL, SMALL
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 8065539
• MDR Text Key: 127060725
• Report Number: 1220246-2018-00741
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867057289
• UDI-Public: 00888867057289
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K010124
• 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: 11/13/2018

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: GLENOID, POLY WITH KEEL, SMALL
• Device Catalogue Number: AR-9104-01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/25/2018
• Initial Date FDA Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other