MAUDE Adverse Event Report: TORNIER INC LATITUDE EV HUMERAL STEM COATED SMALL LEFT 150 MM; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Model Number	0030313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	05/03/2017
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.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Disposition unknown.
Event or Problem Description
It was reported that the patient had an osteosuture on the humeral prosthesis due to them falling on their left elbow.There was a periprosthetic complex fracture of the olecranon and a displacement of the humeral implant.The patient underwent a revision surgery to remove the standard stem and replace with a long stem.
Additional Manufacturer Narrative
Please note corrections to the fda registration number.The mdr was submitted with 3004983210 and should have been reported under 0001649390 registration number.Please note corrections in d1 and d4: the reported event could not be confirmed.The device was not returned.X-rays were provided for the device.Since data was provided, the opinion of a medical expert was sought and stated as follows: the patient had a primary placement of a latitude total elbow prosthesis in (b)(6) 2016.Unfortunately, in 2017 the patient fell and had a comminuted olecranon fracture and a periprosthetic fracture around the humeral component.On (b)(6) 2017, the olecranon fracture was treated, and the humeral component was revised.During the revision, a ¿fausse route¿ was created, the proximal part of the humeral prosthesis and it¿s surrounding bone cement was placed outside the bone.The prosthesis was however fixed well, and the fractures healed, rendering a good elbow function.The position of the prosthesis did not change when comparing postoperative to the 1-year follow up.The postoperative position was an iatrogenic fausse route, placing the implant in varus, and having the proximal part of the humeral component and bone cement sticking out of the bone.This position did not change after the revision surgery during follow-up.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint 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.If the device is returned or any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the patient had an osteosuture on the humeral prosthesis due to them falling on their left elbow.There was a periprosthetic complex fracture of the olecranon and a displacement of the humeral implant.The patient underwent a revision surgery to remove the standard stem and replace with a long stem.

• Brand Name: LATITUDE EV HUMERAL STEM COATED SMALL LEFT 150 MM
• 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: 15323520
• Report Number: 3004983210-2022-00062
• Device Sequence Number: 5203839
• Product Code: JDB
• UDI-Device Identifier: 00846832002764
• UDI-Public: 00846832002764
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/11/2019
• Device Model Number: 0030313
• Device Catalogue Number: 0030313
• Device Lot Number: CC1116082008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2014
• 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; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 82 KG