MAUDE Adverse Event Report: TORNIER S.A.S. RHS; RADIAL HEAD PROSTHESIS

Device Problem Device Issue (2379)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This is the final report submitted regarding this surgical event and medical device.The source of this report is literature: m.Contreras-joyaa, a.Jiménez-martína, f.J.Santos-yuberoa, s.Navarro-martíneza, f.J.Najarro-cida, j.Sánchez-sotelob, s.Pérez-hidalgoa radial head arthroplasty, 11 years' experience: a series of 82 patients rev esp cir ortop traumatol.2015;59(5):307---317.

Event Description

It was reported in literature that : prosthesis removal was necessary in 11 patients ((b)(4)), where the main cause of removal was pronation/supination pain in 5 cases, capitellar lesions in 4 cases, 1 dislocation and 1 infection.M.Contreras-joyaa,a.Jiménez-martína, f.J.Santos-yuberoa, s.Navarro-martíneza, f.J.Najarro-cida, j.Sánchez-sotelob, s.Pérez-hidalgo radial head arthroplasty, 11 years' experience: a series of 82 patients rev esp cir ortop traumatol.2015;59(5):307---317.

• Brand Name: RHS
• Type of Device: RADIAL HEAD PROSTHESIS
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330
• Manufacturer Contact: maud andriollo-sanchez ; 161 rue lavoisier; montbonnot saint martin, 38330 ; FR 38330 ; 76613500
• MDR Report Key: 5700690
• MDR Text Key: 46597303
• Report Number: 3000931034-2016-00075
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention