MAUDE Adverse Event Report: TORNIER INC LATITUDE EV HUMERAL STEM MEDIUM STD RIGHT; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number 0030710

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Implant Pain (4561)

Event Date 09/28/2023

Event Type  Injury  

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.H3 other text : device disposition unknown.

Event Description

The patient experienced heightened pain during maximum flexion, accompanied by slightly elevated inflammatory markers.A ct scan revealed signs of infection around the tip of the ulnar prosthesis.Following a consultation, a spect ct scan was ordered for further assessment.The surgeon indicated that the infection is not directly linked to the implant but is associated with the initial surgery.

Manufacturer Narrative

Correction: b2 outcomes attributed to ae.The reported event 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.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.

Event Description

The patient experienced heightened pain during maximum flexion, accompanied by slightly elevated inflammatory markers.A ct scan revealed signs of infection around the tip of the ulnar prosthesis.Following a consultation, a spect ct scan was ordered for further assessment.The surgeon indicated that the infection is not directly linked to the implant but is associated with the initial surgery.

• Brand Name: LATITUDE EV HUMERAL STEM MEDIUM STD RIGHT
• Type of Device: 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: 18440264
• MDR Text Key: 331863665
• Report Number: 0001649390-2024-00005
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K193247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0030710
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Other
• Patient Age: 55 YR
• Patient Weight: 116 KG