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

Model Number	DKY069
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Implant Pain (4561)
Date of Event	02/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient had fallen and experienced pain.Upon x-ray it was noted that the ulnar locking cap had broken at the hinges and the locking screw had sheared off at the head.The patient had to undergo revision surgery to remove broken components and get new component devices.
Event or Problem Description
It was reported that the patient had fallen and experienced pain.Upon x-ray it was noted that the ulnar locking cap had broken at the hinges and the locking screw had sheared off at the head.The patient had to undergo revision surgery to remove broken components and get new component devices.
Additional Manufacturer Narrative
Correction (d9/h3 was updated), d4 lot#, g1 manufacturing site the reported event could be confirmed.The device was returned and found to be in the condition stated in the event description.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by the user.Excessive force from a patient fall damaged and broke the ulnar cap as noted in this complaint.Per the complaint reporter ¿the patient was satisfied until they had a fall and damaged the ulnar cap.¿ 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 if any additional information is provided, the investigation will be reassessed.

• Brand Name: LATITUDE TOTAL ELBOW ULNAR CAP LARGE
• Common Device Name: 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 MN NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13651516
• Report Number: 3004983210-2022-00043
• Device Sequence Number: 2519548
• Product Code: JDB
• UDI-Device Identifier: 00846832010929
• UDI-Public: 00846832010929
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070787
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/15/2023
• Device Model Number: DKY069
• Device Catalogue Number: DKY069
• Device Lot Number: 1580AU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 03/02/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2018
• 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: Female