MAUDE Adverse Event Report: TORNIER INC LATITUDE TOTAL ELBOW HUMERAL IMPLANT MEDIUM LEFT; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	DKY184
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "patient underwent "left elbow hemiprosthesis surgery (wright)" for "displaced left elbow closed fracture; sequelae of contusions".Due to the constant pain she complained of over the following months, she was referred to another facility where the probable mobilization of the implant was detected and a further surgery was therefore performed for defective humeral with endohumeral consolidation.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and other evidences provided were insufficient to reliably assess this case.A device inspection was not possible since the affected device was not returned.The opinion of the medical expert was requested and stated as following: "the resolution of the images is insufficient to reliably assess the presence of bone cement and the probable mobilization of the implant.With the information presently available and the suboptimal quality of the provided images, it is not feasible to identify factors that may have contributed to the alleged event." 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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "patient underwent "left elbow hemioprosthesis surgery (wright)" for "displaced left elbow closed fracture; sequelae of contusions".Due to the constant pain she complained of over the following months, she was referred to another facility where the probable mobilization of the implant was detected and a further surgery was therefore performed for defective humeral with endohumeral consolidation.".

• Brand Name: LATITUDE TOTAL ELBOW HUMERAL IMPLANT MEDIUM LEFT
• Common Device Name: PROSTHESIS, ELBOW, 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: 17815798
• Report Number: 0001649390-2023-00242
• Device Sequence Number: 12293393
• Product Code: JDC
• UDI-Device Identifier: 00846832012428
• UDI-Public: 00846832012428
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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 Expiration Date: 09/20/2024
• Device Catalogue Number: DKY184
• Device Lot Number: 1344AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2019
• 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 Sex: Unknown