MAUDE Adverse Event Report: TORNIER INC LATITUDE TOTAL ELBOW ULNAR CAP MEDIUM; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number DKY068

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

Patient Problem Joint Dislocation (2374)

Event Date 02/05/2024

Event Type  Injury  

Event Description

A revision surgery was performed at (b)(6) hospital by (b)(6).During the surgery, the ulnar stem (latitude ev) was discovered to be loose, with evidence of poly wear on the ulnar component.The surgeon attributed this to excessive mechanical loading, likely due to the patient's weight.Consequently, the loose components were removed and replaced.The ulnar stem, screw, tab, and ulnar cap were bagged and returned to (b)(4).An additional update stated that the original plan was to replace only the poly bushing and ulnar cap, which would have extended the surgery time by approximately 30 minutes.

Manufacturer Narrative

Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.

• Brand Name: LATITUDE TOTAL ELBOW ULNAR CAP MEDIUM
• Type of Device: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): WRIGHT MEDICAL CORK (TORNIER ORTHOPEDICS IRELAND LTD); harnetts cross; macroom, co. cork NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18822578
• MDR Text Key: 336739622
• Report Number: 0001649390-2024-00077
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K070787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DKY068
• Device Lot Number: 6871AY
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 166 KG