MAUDE Adverse Event Report: TORNIER INC LATITUDE ELB HUMERAL SPOOL SZPETIT SIDE GAUCHE OFFSET CENTRE; PROTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number	DKY212
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
It was reported that, the patient underwent left total elbow replacement on (b)(6) 2025, following a fall (sustained a fractured left distal humerus).Patient presented approximately 2 x weeks ago to hospital with pain, increased swelling, redness in left elbow joint: malaise.Commenced on antibiotics.No improvement.Decision made to open wound and irrigate suspected prosthetic elbow joint infection.During surgery, a large collection of pus was drained from the left elbow - approx 2 litres.Multiple samples / specimens taken.Wound debrided.Copious lavage.Surgeon decided to exchange the ulnar cap implant, plus the humeral spool and locking screw.These were replaced without difficulty.Wound closed.
Additional Manufacturer Narrative
The reported event could be confirmed, since medical imaging of the reported event was provided.The evaluation of the provided imaging revealed the following: the postoperative x-rays provided by the reporter show marked soft tissue swelling and the presence of subcutaneous air.These findings are most consistent with a small cutaneous fistula.However, the implant remains intact and well-fixed to the bone.Based on investigation, the root cause was attributed to a patient related issue not related to the device itself.The event was caused by a postoperative periprosthetic joint infection.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 more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that, the patient underwent left total elbow replacement on (b)(6) 2025, following a fall (sustained a fractured left distal humerus).Patient presented approximately 2 x weeks ago to hospital with pain, increased swelling, redness in left elbow joint: malaise.Commenced on antibiotics.No improvement.Decision made to open wound and irrigate suspected prosthetic elbow joint infection.During surgery, a large collection of pus was drained from the left elbow - approx 2 litres.Multiple samples / specimens taken.Wound debrided.Copious lavage.Surgeon decided to exchange the ulnar cap implant, plus the humeral spool and locking screw.These were replaced without difficulty.Wound closed.

• Brand Name: LATITUDE ELB HUMERAL SPOOL SZPETIT SIDE GAUCHE OFFSET CENTRE
• Common Device Name: PROTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23877741
• Report Number: 0001649390-2025-00960
• Device Sequence Number: 20016680
• Product Code: JDB
• UDI-Device Identifier: 00846832011124
• UDI-Public: (01)00846832011124(11)240804(17)290804(21)9521BA010
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: DKY212
• Device Lot Number: 9521BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/04/2024
• 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: 61 YR
• Patient Sex: Female