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 Problem Patient-Device Incompatibility (2682)

Patient Problem Injury (2348)

Event Date 01/21/2019

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 root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the subject underwent a revision rtsa surgery on (b)(6) 2019 where the following hardware was explanted: ar-9104-01 / lot: 160055314.Ide-ar-9300-43cpc / lot: 2501362509.Ide-ar-9343-16 / lot: 1707001.Ide-ar-9301-02 / lot: 2501490914.The reason for the explant is the subject has a complete tear of right rotator cuff.This revision is secondary to a complete rotator cuff tear.The subject has good bone quality.There was no evidence of loosening of the implant.

Manufacturer Narrative

Complaint not confirmed.The failure mode detailed in the event description could not be replicated.Visual evaluation revealed minor superficial scratches along the surface and outer diameter of the glenoid.This is consistent with damage incurred during the removal process.No problem was identified with the returned ar-9104-01 glenoid.

• 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
• MDR Report Key: 8349744
• MDR Text Key: 136478214
• Report Number: 1220246-2019-00911
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867057289
• UDI-Public: 00888867057289
• Combination Product (y/n): N
• PMA/PMN Number: K010124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

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 Expiration Date: 09/03/2021
• Device Model Number: GLENOID, POLY WITH KEEL, SMALL
• Device Catalogue Number: AR-9104-01
• Device Lot Number: 160055314
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other