MAUDE Adverse Event Report: STRYKER GMBH LATITUDE ELBOW ULNAR CAP MODEL GRAND; LATITUDE TOTAL ELBOW ULNAR CAP LARGE

Catalog Number	DKY069
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported a patient experienced an infection that led to unanticipated revision surgery.Debridement/ wash out of previous total elbow elbow replacement due to infection.The surgeon stated the infection has been present for 12 months.No exact dates beyond this are known.The ulnar cap was explanted.No issue with implants.Removed due to the reported infection.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported a patient experienced an infection that led to unanticipated revision surgery.Debridement/ wash out of previous total elbow replacement due to infection.The surgeon stated the infection has been present for 12 months.No exact dates beyond this are known.The ulnar cap was explanted.No issue with implants.Removed due to the reported infection.

• Brand Name: LATITUDE ELBOW ULNAR CAP MODEL GRAND
• Common Device Name: LATITUDE TOTAL ELBOW ULNAR CAP LARGE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach MN 2545 ; SZ 2545
• 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: 19652777
• Report Number: 0001649390-2024-00295
• Device Sequence Number: 6596447
• Product Code: JDB
• UDI-Device Identifier: 00846832010929
• UDI-Public: 00846832010929
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K07087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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 Catalogue Number: DKY069
• Device Lot Number: 8676AX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2022
• 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 Sex: Unknown