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

Model Number	GLENOID, PE WITH PEG, MEDIUM
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
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 peg glenoid ar-9105-02 became loose through abrasion.The following components are involved.Ar-9102-02 w.Batch unk.Ar-9300-43cpc w.Batch 12315.Ar-9301-02 w.Batch 12537.Ar-9343-16 w.Batch 11295131006.Devices will be returned for investigation, therefore, revision surgery has been performed.No further information has been provided.
Additional Manufacturer Narrative
Complaint confirmed, the device is heavily worn, damaged and the central peg is broken.The device could not be measured due to the damaged condition.The cause of the event is undetermined.

• Brand Name: GLENOID, PE WITH PEG, MEDIUM
• 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: 10786967
• Report Number: 1220246-2020-02314
• Device Sequence Number: 2938267
• Product Code: KWS
• UDI-Device Identifier: 00888867057326
• UDI-Public: 00888867057326
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083435
• Number of Events Summarized: 1
• Summary Report (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): 05/03/2021

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, MEDIUM
• Device Catalogue Number: AR-9105-02
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 05/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other