MAUDE Adverse Event Report: TORNIER INC LATITUDE ELBOW HUMERAL SCREW SIZE MEDIUM; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number	DKY192
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Discomfort (2330); Implant Pain (4561)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was originally reported under 0001649390-2024-00266.Which was the wrong event.Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to discomfort and stiffness and reduced range of motion.All prosthesis removed, and discarded.Specimens taken for pathology.All original bone cement removed.Copious lavage attended.All joint and medullary canal surfaces irrigated with aqueous betadine.Full set of prosthesis cemented in, with antibiotic cement.
Additional Manufacturer Narrative
Correction: h6 method code.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient underwent a revision surgery due to discomfort and stiffness and reduced range of motion.All prosthesis removed, and discarded.Specimens taken for pathology.All original bone cement removed.Copious lavage attended.All joint and medullary canal surfaces irrigated with aqueous betadine.Full set of prosthesis cemented in, with antibiotic cement.

• Brand Name: LATITUDE ELBOW HUMERAL SCREW SIZE MEDIUM
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20108283
• Report Number: 0001649390-2024-00419
• Device Sequence Number: 18079637
• Product Code: JDB
• UDI-Device Identifier: 00846832012466
• UDI-Public: 00846832012466
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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 Expiration Date: 02/04/2024
• Device Catalogue Number: DKY192
• Device Lot Number: 4134AM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/30/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2019
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 80 KG