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

Model Number DKY069

Device Problems Break (1069); Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 04/21/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent a revision due to screw/cap breakage 7 years post-op.

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

It was reported that the patient underwent a revision due to screw/cap breakage 7 years post-op.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.A review of the device history was not possible because the correct lot number was not communicated.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
• 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: 14427594
• MDR Text Key: 291936068
• Report Number: 0001649390-2022-00004
• Device Sequence Number: 1
• Product Code: JDB
• UDI-Device Identifier: 00846832010929
• UDI-Public: 00846832010929
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K070787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DKY069
• Device Catalogue Number: DKY069
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• 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): Hospitalization; Required Intervention