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

Model Number DKY069

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 11/05/2021

Event Type  Injury  

Manufacturer Narrative

The device evaluation was anticipated but not yet begun.If additional information becomes available, it will be provided in a supplemental report.

Event Description

A patient had a total elbow replacement using the latitude ev system on the (b)(6) 2021 and was revised on the (b)(6) 2021 due to the screw preventing back out tab on the ulnar cap dky069 breaking and the screw backing out completely into the joint.The surgeon says the patient was doing extremely well with the elbow and was only when they got an xray he realised what had happened.The revision operation involved removing the broken ulnar cap, broken back out tab (in soft tissue) and screw (also in soft tissue).And replacing it with another size specific cap dky069.Nothing was noted in the initial surgery as being unusual and the surgeon has been implanting latitudes/ latitude ev's for about 15 years.

Manufacturer Narrative

Corrections: please refer to d9/h3 product return and device evaluation.The reported event could be confirmed since x-rays were provided for the investigation and confirmed the reported event ¿broken back out tab (in soft tissue)¿.No other evidences were provided for investigation.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.

Event Description

A patient had a total elbow replacement using the latitude ev system on the (b)(6) 2021 and was revised on the (h)(6) 2021 due to the screw preventing back out tab on the ulnar cap dky069 breaking and the screw backing out completely into the joint.The surgeon says the patient was doing extremely well with the elbow and was only when they got an xray he realised what had happened.The revision operation involved removing the broken ulnar cap, broken back out tab (in soft tissue) and screw (also in soft tissue).And replacing it with another size specific cap dky069.Nothing was noted in the initial surgery as being unusual and the surgeon has been implanting latitudes/ latitude ev's for about 15 years.

• Brand Name: LATITUDE TOTAL ELBOW ULNAR CAP LARGE
• Type of Device: ELBOW SEMI-CONSTRAINED CEMENTED PROSTHESIS
• 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: 12939739
• MDR Text Key: 281855008
• Report Number: 3004983210-2021-00083
• Device Sequence Number: 1
• Product Code: JDB
• UDI-Device Identifier: 00846832010929
• UDI-Public: 00846832010929
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• 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: 6822AU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2019
• 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: 54 YR
• Patient Sex: Male