MAUDE Adverse Event Report: AEQUALIS PERFORM GLENOID; SHOULDER JOINT POLYMER PROSTHESIS

Model Number	PEGGED SIZE S30
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the initial report submitted regarding this surgical event and medical device.
Event or Problem Description
"(b)(6) 2017, initial surgery of ''aequalis perform glenoid'' was performed.After the surgery, the patient visited the hospital several times, but there was no abnormality.In the meantime, he fell down several times and had an x-ray examination in (b)(6) 2019, but found no problem.(b)(6) 2019, the patient visited the hospital for pain and after the examination, it was confirmed that the glenoid peg had fallen out.(b)(6) 2019, revision surgery was performed.The four holes for the glenoid peg looked good and only the glenoid peg was falled out, but it wasn't deformed or damaged.Since the cause was unknown, it was judged that the peg glenoid should not be added again, and the surgery was completed and the glenoid area was left as it was.".
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.

• Brand Name: AEQUALIS PERFORM GLENOID
• Common Device Name: SHOULDER JOINT POLYMER PROSTHESIS
• MDR Report Key: 9450110
• Report Number: 3000931034-2019-00181
• Device Sequence Number: 13989841
• Product Code: KWS
• UDI-Device Identifier: 03700386937330
• UDI-Public: 03700386937330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: Lay User/Patient
• Device Expiration Date: 04/18/2021
• Device Model Number: PEGGED SIZE S30
• Device Catalogue Number: DWE301
• Device Lot Number: 2049AR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR