MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC AEQUALIS REVERSED STANDARD INSERT 42 MM X 6 MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number DWB996

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/20/2022

Event Type  Injury  

Event Description

It was reported that the patient had a wound washout and the poly was changed due to an infection.There was a revision procedure.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.The device disposition is unknown.

Manufacturer Narrative

This is a duplicate report of 0001649390-2022-00003.Any new information will be submitted on that report.

Event Description

It was reported that the patient had a wound washout and the poly was changed due to an infection.There was a revision procedure.

• Brand Name: AEQUALIS REVERSED STANDARD INSERT 42 MM X 6 MM
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15579206
• MDR Text Key: 301483344
• Report Number: 0001649390-2022-00080
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 03700386916571
• UDI-Public: 03700386916571
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K050316
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: DWB996
• Device Catalogue Number: DWB996
• Device Lot Number: AB8361013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male