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

Catalog Number	DKY067
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Synovitis (2094); Fluid Discharge (2686)
Date of Event	07/24/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3000931034-2023-00254
• Device Sequence Number: 8367888
• Product Code: PHX
• UDI-Device Identifier: 00846832010905
• UDI-Public: 00846832010905
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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 Catalogue Number: DKY067
• Device Lot Number: 2625AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2021
• 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
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 53 KG