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

Catalog Number	0030720
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); Numbness (2415); Joint Laxity (4526)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event that the patient required revision surgery due to elbow dislocation and instability in the joint 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: "post-operative complications surfaced eight days following the initial surgery involving the latitude ev implant.The patient had elbow dislocation, signifying significant instability in the joint.The patient presented at the (b)(6) with intermittent dislocations and reported sensations of pins and needles in the affected area.The surgeon confirmed a causal relationship between these complications and the implantation surgery.To address the issues, a revision surgery was deemed necessary to reposition the ulnar cap.The re-operation took place on (b)(6) 2023." update on (b)(6) 2023 the operated elbow was the right.Hand dominance = operated.

• Brand Name: LATITUDE EV HUMERAL STEM LARGE STD RIGHT
• 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: 17951592
• Report Number: 0001649390-2023-00271
• Device Sequence Number: 12459934
• Product Code: JDC
• UDI-Device Identifier: 00846832074808
• UDI-Public: 00846832074808
• 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
• Device Explanted 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: 0030720
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 82 KG