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
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that the patient returned 3 years after eclipse surgery.The patient had returned to have a revision to a reverse prothesis because the patient had torn her rotator cuff and subscapularis muscle.On xray the keel looked to be solid and in place.When the surgeon performed the surgery on the shoulder he realized that the keel was worn and had fully snapped off laying loose in the joint.That's why the keel was removed and the surgeon kept going with the reverse prothesis surgery.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed the glenoid was found to be damaged and/or worn.The outside surface (keel side), showed the keel is broken and no trace of cement was noticed.The absence of cement is the most likely cause of loosening of the glenoid plate.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed the glenoid was found to be damaged and/or worn.The outside surface (keel side), showed the keel is broken and no trace of cement was noticed.Likely cause(s) of this event include improper bone preparation, improper implant placement, improper bone cementing and/or patient non-compliance.

• Brand Name: GLENOID, POLY WITH KEEL, SMALL
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8861285
• Report Number: 1220246-2019-01225
• Device Sequence Number: 16601511
• Product Code: KWS
• UDI-Device Identifier: 00888867057289
• UDI-Public: 00888867057289
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K10124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2019

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
• Operator of Device: Health Professional
• Device Model Number: GLENOID, POLY WITH KEEL, SMALL
• Device Catalogue Number: AR-9104-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019; 07/15/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 09/05/2019; 10/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other