MAUDE Adverse Event Report: TORNIER S.A.S. LATITUDE TOTAL ELBOW ULNAR CAP SMALL; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Catalog Number DKY067

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Synovitis (2094); Fluid Discharge (2686)

Event Date 07/24/2023

Event Type  Injury  

Event Description

A patient underwent a primary left elbow replacement.The patient had a history of a chronic discharging sinus around the elbow's suture line, leading to multiple drainage procedures and samples taken, but no specific organism was identified.The diagnosis was aseptic synovitis.The patient had other prosthetic joints without issues such as metal sensitivity or infection.During the procedure, a new sterile component replaced the ulna locking cap, while other components remained unchanged.Extensive synovial debridement was performed, multiple tissue samples were taken, and the area was thoroughly cleansed.The surgical team was able to close the tissues and skin after the procedure.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : the device has been discarded.

Event Description

A patient underwent a primary left elbow replacement.The patient had a history of a chronic discharging sinus around the elbow's suture line, leading to multiple drainage procedures and samples taken, but no specific organism was identified.The diagnosis was aseptic synovitis.The patient had other prosthetic joints without issues such as metal sensitivity or infection.During the procedure, a new sterile component replaced the ulna locking cap, while other components remained unchanged.Extensive synovial debridement was performed, multiple tissue samples were taken, and the area was thoroughly cleansed.The surgical team was able to close the tissues and skin after the procedure.

Manufacturer Narrative

The reported event that was not confirmed, since the device was not returned for evaluation and no other evidences 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.No indications of material, manufacturing or design related problems were found during the investigation.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 in order 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.

• Brand Name: LATITUDE TOTAL ELBOW ULNAR CAP SMALL
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17575404
• MDR Text Key: 321518482
• Report Number: 3000931034-2023-00254
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00846832010905
• UDI-Public: 00846832010905
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K161742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: DKY067
• Device Lot Number: 2625AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• 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: 82 YR
• Patient Sex: Female
• Patient Weight: 53 KG