MAUDE Adverse Event Report: TORNIER S.A.S. RADIAL PROSTHESIS STEM DIA. 6.5MM; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Catalog Number	DTJ006
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Loss of Range of Motion (2032); Osteolysis (2377); Implant Pain (4561)
Date of Event	09/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "post operative complication: bone cyst / osteolysis / bone resorption severe pain of the left elbow postero-lateral.Partial loss of range of motion." update following clinical team feedback: "two years post-surgery, the patient encountered intense pain in the postero-lateral region of the left elbow, accompanied by a partial loss of range of motion.Subsequent to a follow-up visit, a bone cyst was conclusively diagnosed marking a significant adverse event (sae) ¿permanent impairment of a body structure or function¿.According to the surgeon, this event has a causal relationship to the implant and a possible relationship to the surgery.To address this, revision surgery was performed on (b)(6) 2024 to remove the prosthesis, but without any replacement.The event was resolved without sequelae on (b)(6) 2024.The removal of the prosthesis resulted in complete alleviation of pain, rendering the left elbow pain-free, stable, and fully restored to its full range of motion.".

• Brand Name: RADIAL PROSTHESIS STEM DIA. 6.5MM
• Common Device Name: PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18817474
• Report Number: 3000931034-2024-00067
• Device Sequence Number: 17271153
• Product Code: JDB
• UDI-Device Identifier: 03700386901218
• UDI-Public: 03700386901218
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K994041
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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: DTJ006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 03/01/2024
• 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: 58 YR
• Patient Sex: Unknown
• Patient Weight: 75 KG