MAUDE Adverse Event Report: TORNIER INC LATITUDE EV ULNAR STEM 75 MM MEDIUM LEFT; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number 0030121

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

Patient Problem Unspecified Infection (1930)

Event Date 02/05/2024

Event Type  Injury  

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.

Event Description

During a surgical procedure, the #5 flexible reamer broke while being used on a patient's elbow.Both pieces of the reamer were retrieved, and an x-ray was taken, which showed no abnormalities.The original intended procedure was the removal of hardware from the right elbow, insertion of a cement antibiotic spacer, irrigation and debridement of the right elbow, and bursectomy of the olecranon bursa.The user encountered problems related to device failure and malfunction.

• Brand Name: LATITUDE EV ULNAR STEM 75 MM MEDIUM LEFT
• 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: 18822906
• MDR Text Key: 336731674
• Report Number: 0001649390-2024-00081
• Device Sequence Number: 1
• Product Code: JDB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100562
• 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 Operator: Lay User/Patient
• Device Catalogue Number: 0030121
• Device Lot Number: CC0218338020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/05/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 166 KG