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

Catalog Number	DKY068
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inadequate Osseointegration (2646); Implant Pain (4561)
Date of Event	07/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported: the patient underwent right elbow replacement on (b)(6) 2020.The primary implants in the joint became infected, and a revision surgery was performed approximately 3 months later, where several components were exchanged, debridement / specimens collected / lavage.According to the surgeon, the patient has undergone several washouts / debridement procedures of his right elbow joint, since.The patient has significant co-morbidities, which has prevented more substantial surgery.However, the patient has been experiencing significant pain over recent months.Additionally, it was reported there was a loose ulnar component.Decision made to exchange this component, including humeral spool.Primary ulnar component removed (very easily), canal debrided, multiple specimens taken, copious lavage performed, and a longer ulnar stem cemented in place.
Additional Manufacturer Narrative
The reported event could be confirmed based on the evaluation done by hcp on the provided x-ray image.The device inspection was not possible as the product was not returned 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.No indications of material manufacturing or design related problems were found during the investigation.Microbiologist reviewed the sterilization procedures environmental monitoring bioburden data and the dhr and noted: the subject device was packaged according to established design and process specifications and was sterilized according to procedure.No deviation for a non-conformance could be found.A review of the labeling did not indicate any abnormalities.However on the available x-rays medical opinion was sought from an experienced independent medical expert as below, yes the x-ray confirms loosening of the ulna component and the bone aspect fits the adverse event ae of a chronic periprosthetic infection pji.The conclusion of an infected surgical site pji is correct.The device itself is intact.More detailed information radiological and clinical about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.However infections are often caused by a multitude of factors such as comorbidity of the patient the trauma the surgical intervention and the aftercare.If any further information is provided the complaint report will be updated.
Event or Problem Description
It was reported: the patient underwent right elbow replacement on (b)(6) 2020.The primary implants in the joint became infected, and a revision surgery was performed approximately 3 months later, where several components were exchanged, debridement / specimens collected / lavage.According to the surgeon, the patient has undergone several washouts / debridement procedures of his right elbow joint, since.The patient has significant co-morbidities, which has prevented more substantial surgery.However, the patient has been experiencing significant pain over recent months.Additionally, it was reported there was a loose ulnar component.Decision made to exchange this component, including humeral spool.Primary ulnar component removed (very easily), canal debrided, multiple specimens taken, copious lavage performed, and a longer ulnar stem cemented in place.

• Brand Name: LATITUDE ELBOW ULNAR CAP MODEL MOYEN
• 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 NA ; EI NA
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19997080
• Report Number: 0001649390-2024-00376
• Device Sequence Number: 4343371
• Product Code: JDB
• UDI-Device Identifier: 00846832010912
• UDI-Public: (01)00846832010912(17)240517(10)7010AU036
• 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 Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/17/2024
• Device Catalogue Number: DKY068
• Device Lot Number: 7010AU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2019
• 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 Age: 71 YR
• Patient Sex: Male