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

Model Number GLENOID, PE WITH PEG, SMALL

Device Problems Defective Component (2292); Appropriate Term/Code Not Available (3191)

Patient Problems Abrasion (1689); Pain (1994)

Event Date 07/02/2020

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 loosening and breakage of the glenoid component due to pe abrasion occurred.Revision surgery performed with prosthesis removal, implantation of an inverse shoulder prosthesis on the right from a different manufacturer.Intraoperatively, defect of the glenoid was confirmed.Initial surgery was performed on (b)(6) 2013, date of revision surgery was (b)(6) 2020.Male patient, yob: (b)(6).No further information has been made available.Update 13-jul-2020: following update received 13-jul-2020: the patient suffered from pain and went to the hospital, no known trauma that could have caused the pain.Patient does not have an extraordinarily high bmi or any known extraordinarily stress.

Event Description

It was reported that loosening and breakage of the glenoid component due to pe abrasion occurred.Revision surgery performed with prosthesis removal, implantation of an inverse shoulder prosthesis on the right from a different manufacturer.Intraoperatively, defect of the glenoid was confirmed.Initial surgery was performed on (b)(6) 2013, date of revision surgery was (b)(6) 2020.Male patient, yob: 1943.No further information has been made available.Further questions being asked.Additional information obtained 13-jul-2020: the patient suffered from pain and went to the hospital, no known trauma that could have caused the pain.Patient does not have an extraordinarily high bmi or any known extraordinarily stress.Additional information obtained 27-oct-2020: the part numbers of the explanted arthrex devices has been provided and are as follows: ar-9105-01 w/ batch 1221011.Ar-9343-16 w/ batch 1295122004.Ar-9300-43cpc w/ batch 12.055.Ar-9301-02 w/ batch 12.363.

Manufacturer Narrative

Complaint confirmed, the glenoid poly was found to be worn and cracked.The wear was offset toward the anterior edge of the device.Both pegs and the keel were broken.The cause of the event is undetermined.

• Brand Name: GLENOID, PE WITH PEG, 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: 10308170
• MDR Text Key: 200453482
• Report Number: 1220246-2020-01962
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867057319
• UDI-Public: 00888867057319
• Combination Product (y/n): N
• PMA/PMN Number: K083435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GLENOID, PE WITH PEG, SMALL
• Device Catalogue Number: AR-9105-01
• Device Lot Number: 1221011
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other