MAUDE Adverse Event Report: TORNIER INC LATITUDE EV ULNAR STEM; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Model Number	0030220
Medical Device Problem Codes	Osseointegration Problem (3003); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.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.The medical opinion of a medical expert was requested to evaluate the risk of this event: after review of the welbow report ¿after a detailed review i conclude the following: the x-ray of (b)(6) 2022 indeed show radiolucent lines indication loosing of the ulnar component of this latitude elbow prosthesis.The operation was performed following the standard of care.The surgeon has repaired the lateral and medial collateral ligaments during the index surgical procedure.The surgeon noticed elderly but good bone quality.The root cause for this loosening cannot be determined from the information available, since there is no information on the actual joint stability (instability of the joint can lead to early loosening), joint mobility, and the assessment of periprosthetic joint infection.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device remains implanted in patient.
Event or Problem Description
It was reported that the patient had a component loosening as a post-operative complication."gradual onset of pain and feeling of instability.Radiographic lucency around ulnar component seen x-ray.

• Brand Name: LATITUDE EV ULNAR STEM
• Common Device Name: PROSTHESIS, ELBOW, 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: nathe hendricks ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14373635
• Report Number: 0001649390-2022-00002
• Device Sequence Number: 16655759
• Product Code: JDC
• UDI-Device Identifier: 00846832002665
• UDI-Public: 00846832002665
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2022

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: 08/22/2020
• Device Model Number: 0030220
• Device Catalogue Number: 0030220
• Device Lot Number: CC0217097021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• 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: Other
• Patient Age: 85 YR
• Patient Sex: Male