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
Health Effect - Clinical Codes	Abrasion (1689); Pain (1994)
Date of Event	07/02/2020
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 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 or Problem 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.
Additional 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
• 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: 10308170
• Report Number: 1220246-2020-01962
• Device Sequence Number: 10977771
• Product Code: KWS
• UDI-Device Identifier: 00888867057319
• UDI-Public: 00888867057319
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2020

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, PE WITH PEG, SMALL
• Device Catalogue Number: AR-9105-01
• Device Lot Number: 1221011
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 11/11/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other