MAUDE Adverse Event Report: AEQUALIS REVERSED FX ADAPTER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number	DWD860
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device discarded and will not be returned for evaluation.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported there was suspicion of superficial infection at the surgical site of the artificial shoulder joint was considered in a patient.As a precaution, the affected part is planned to be cut open and confirmed and after cleaning the affected part, replacement of the insert might be performed depending on the situation of the infection at that time.
Additional Manufacturer Narrative
The reported event that was alleged of issue ¿infection¿ could not be confirmed, since the device was not returned for evaluation and no other evidence were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported there was suspicion of superficial infection at the surgical site of the artificial shoulder joint was considered in a patient.As a precaution, the affected part is planned to be cut open and confirmed and after cleaning the affected part, replacement of the insert might be performed depending on the situation of the infection at that time.The surgery was performed as scheduled.The surgeon opened the part of the joint and confirmed that there were no symptoms of infection in or around the joint prosthesis.As a precaution, the insert implant was replaced.This insert was to be discarded at the hospital due to the possibility of infection.There were no symptoms of infection in the submuscular layer, only some contamination in the subcutaneous layer, which was cleaned and the tissue was scraped out.The surgeon commented that it was not a problem with the implant since there was no problem in the joint or around the prosthesis, only on the surface.

• Brand Name: AEQUALIS REVERSED FX ADAPTER
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• MDR Report Key: 12482518
• Report Number: 3000931034-2021-00319
• Device Sequence Number: 3736893
• Product Code: KWS
• UDI-Device Identifier: 03700386931499
• UDI-Public: 03700386931499
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

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: Lay User/Patient
• Device Expiration Date: 10/13/2025
• Device Model Number: DWD860
• Device Catalogue Number: DWD860
• Device Lot Number: 9942AV16
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention