MAUDE Adverse Event Report: TORNIER INC LATITUDE EV ULNAR STEM 70 MM SMALL RIGHT; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Model Number	0030020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	09/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an infection in the operated area which required a revision to remove the metal work in the elbow joint.The patient was hospitalized for greater than 24 hours.
Additional Manufacturer Narrative
The reported event could not be confirmed.The device was not returned.X-rays were provided for the device.Since data was provided, the opinion of a medical expert was sought and stated as follows: from the information provided i can conclude that the patient received an elbow arthroplasty of the right elbow on (b)(6) 2021.Relevant medical history encompasses rheumatoid arthritis.Several months after the procedure, end of january 2021 the patient was assessed for swelling of the elbow and pain.Over the months that followed, a deep infection (that is a prosthetic joint infection or pji) was confirmed through open biopsy and wash-out of the joint.The presence of a sinus (that¿s a pinpoint lesion of the skin being the point of entry of a sinus tract that form an open connection of the outside world to the infected site), and periprosthetic osteolysis on the x-ray, confirm this pji.Rheumatoid arthritis is a risk factor for infection in joint replacement in general.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.If the device is returned or any further information is provided, the complaint report will be updated.
Additional Manufacturer Narrative
The reported event could not be confirmed.The device was not returned.X-rays were provided for the device.Since data was provided, the opinion of a medical expert was sought and stated as follows: from the information provided i can conclude that the patient received an elbow arthroplasty of the right elbow on (b)(6) 2021.Relevant medical history encompasses rheumatoid arthritis.Several months after the procedure, end of (b)(6) 2021 the patient was assessed for swelling of the elbow and pain.Over the months that followed, a deep infection (that is a prosthetic joint infection or pji) was confirmed through open biopsy and wash-out of the joint.The presence of a sinus (that¿s a pinpoint lesion of the skin being the point of entry of a sinus tract that form an open connection of the outside world to the infected site), and periprosthetic osteolysis on the x-ray, confirm this pji.Rheumatoid arthritis is a risk factor for infection in joint replacement in general.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.If the device is returned or any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the patient had an infection in the operated area which required a revision to remove the metal work in the elbow joint.The patient was hospitalized for greater than 24 hours.

• Brand Name: LATITUDE EV ULNAR STEM 70 MM SMALL RIGHT
• Common Device Name: PROSTHESIS, ELBOW, SEMI-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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15726071
• Report Number: 0001649390-2022-00093
• Device Sequence Number: 7204467
• Product Code: JDB
• UDI-Device Identifier: 00846832002481
• UDI-Public: 00846832002481
• 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: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/24/2023
• Device Model Number: 0030020
• Device Catalogue Number: 0030020
• Device Lot Number: CC0419291023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 71 KG