MAUDE Adverse Event Report: TORNIER INC LATITUDE EV HUMERAL STEM MEDIUM STD LEFT; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	0030711
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that patient had a medial column fracture during the surgery could not be confirmed, since the device(s) were not returned for evaluation and no other additional information was received from the clinical site.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause.   if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "intra-operative complications during the initial surgery involving the latitude ev implant.The patient had medial column fracture during the surgery.The surgeon confirmed a causal relationship between this fracture and the surgery procedure.However, this event is not related to the implant.No actions were needed to address the issues.The event was resolved without sequelae on (b)(6) 2023".Update on (b)(6) 2023 : the operated elbow was the left.Hand dominance = opposite.There was no increase in the operation time.

• Brand Name: LATITUDE EV HUMERAL STEM MEDIUM STD LEFT
• Common Device Name: PROSTHESIS, ELBOW, 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: 17952632
• Report Number: 0001649390-2023-00275
• Device Sequence Number: 15359312
• Product Code: JDC
• UDI-Device Identifier: 00846832074754
• UDI-Public: 00846832074754
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2023

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: 0030711
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 54 KG