MAUDE Adverse Event Report: TORNIER S.A.S. RHS RADIAL HEAD DIA 18MM; SEMI-CONSTRAINED CEMENTED ELBOW PROSTHESIS

Model Number	DTJ301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned as it remains implanted.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that patient (b)(6) had a post-operative complication due to abnormal or persistent pain, defined as "continuing pain at the elbow", 8 months after primary surgery.Treatment / medication: blood tests and x-ray.Ae outcome: resolved without sequelae.

• Brand Name: RHS RADIAL HEAD DIA 18MM
• Common Device Name: SEMI-CONSTRAINED CEMENTED ELBOW PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 13155600
• Report Number: 3000931034-2022-00001
• Device Sequence Number: 17163507
• Product Code: JDB
• UDI-Device Identifier: 03700386927034
• UDI-Public: 03700386927034
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/04/2022

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 Model Number: DTJ301
• Device Catalogue Number: DTJ301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 01/04/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 95 KG