MAUDE Adverse Event Report: TORNIER INC. LATITUDE ELBOW PROSTHESIS

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Neuropathy (1983)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.Literature reference: hemiarthroplasty of the distal humerus for acute and chronic complex intra-articular injuries.Donald w.Hohman, md, scott r.Nodzo, md, lars m.Qvick, md, thomas r.Duquin, md, paul p.Paterson, md; journal of shoulder and elbow surgery 2014, vol.23, 265-272.
Event or Problem Description
It was reported in the literature (hohman, donald et al.2014), there were 5 complications in 5 patients implanted with the latitude prothesis.One patient sustained an intraoperative fracture of the humeral diaphysis, which underwent reduction with fixation at the time of surgery, and healed uneventfully with no apparent effect on outcome.Four patients required 1 or more subsequent surgical procedures; however, there were no component revisions or conversions to total elbow arthroplasty.Three patients required removal of prominent supplementary instrumentation used for fixation, one of which was for kirschner wires, one for the supplementary suture button device, and one from the olecranon osteotomy fixation.In the fourth patient, a postoperative ulnar neuropathy developed and ulnar nerve transposition was required 8 months postoperatively.No further patient complications have been reported.

• Brand Name: LATITUDE ELBOW PROSTHESIS
• Common Device Name: ELBOW PROSTHESIS
• Manufacturer (Section D): TORNIER INC.; 10801 nesbitt avenue s; bloomington MN 55437
• MDR Report Key: 7703035
• Report Number: 3004983210-2018-00032
• Device Sequence Number: 2770965
• Product Code: JDB
• UDI-Device Identifier: 00846832010912
• UDI-Public: 00846832010912
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K100562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2018

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?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention