MAUDE Adverse Event Report: TORNIER S.A.S. RHS RADIAL HEAD DIA 20MM; PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Model Number	DTJ302
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	09/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rhs radio head implant was implanted.The patient was fine after 3 months worth of check ups but came back with elbow pain.The x-ray showed that the head of the radio head had pop off the implant and was lateral.There was a revision surgery performed.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Additional Manufacturer Narrative
The reported event could not be confirmed since no x-rays were returned for evaluation or no other evidences were provided.As the plastic component of the radial head was implanted and therefore deformed (as the radial head was implanted into the metal stem 4 months ago and was explanted for revision), a dimensional and functional inspection was not possible.However, during manufacturing, functionality test and dimensional inspection were done according to specifications, especially, during the manufacturing process, a dimensional inspection and a part destructive test were performed on radial heads from the same batch with no issue to report.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If any additional information (as x-rays) is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the rhs radio head implant was implanted.The patient was fine after 3 months worth of check ups but came back with elbow pain.The x-ray showed that the head of the radio head had pop off the implant and was lateral.There was a revision surgery performed.

• Brand Name: RHS RADIAL HEAD DIA 20MM
• 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: 15562763
• Report Number: 3000931034-2022-00340
• Device Sequence Number: 6501670
• Product Code: JDB
• UDI-Device Identifier: 03700386927041
• UDI-Public: 03700386927041
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K060438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: DTJ302
• Device Catalogue Number: DTJ302
• Device Lot Number: 7012AU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/13/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 60 YR
• Patient Sex: Female