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

Catalog Number	DKY068
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A revision surgery was performed at (b)(6) hospital by (b)(6).During the surgery, the ulnar stem (latitude ev) was discovered to be loose, with evidence of poly wear on the ulnar component.The surgeon attributed this to excessive mechanical loading, likely due to the patient's weight.Consequently, the loose components were removed and replaced.The ulnar stem, screw, tab, and ulnar cap were bagged and returned to (b)(4).An additional update stated that the original plan was to replace only the poly bushing and ulnar cap, which would have extended the surgery time by approximately 30 minutes.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
A revision surgery was performed at (b)(6) hospital by (b)(6).During the surgery, the ulnar stem (latitude ev) was discovered to be loose, with evidence of poly wear on the ulnar component.The surgeon attributed this to excessive mechanical loading, likely due to the patient's weight.Consequently, the loose components were removed and replaced.The ulnar stem, screw, tab, and ulnar cap were bagged and returned to stryker (b)(4).An additional update stated that the original plan was to replace only the poly bushing and ulnar cap, which would have extended the surgery time by approximately 30 minutes.
Additional Manufacturer Narrative
Please note this device is concomitant and did not contribute to the reported failure.It was reported in error.

• Brand Name: LATITUDE TOTAL ELBOW ULNAR CAP MEDIUM
• 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: 18822578
• Report Number: 0001649390-2024-00077
• Device Sequence Number: 12674074
• Product Code: JDB
• UDI-Device Identifier: 00846832010912
• UDI-Public: 00846832010912
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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
• Device Catalogue Number: DKY068
• Device Lot Number: 6871AY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 166 KG