MAUDE Adverse Event Report: SYNTHES USA; RADIAL HEAD PROSTHESIS SYSTEM

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient information not provided by reporter.This report is for one unknown radial head prosthesis system/lot number.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that an orthopedic surgeon with the orthopedic institute has informed a sales consultant that he has had two cases where the radial stem from the radial head prosthesis system is loosening over time, even though he believes his surgical technique was followed, and proper stem selection and fit was initially correct.The sales consultant was with the surgeon in both cases, and the procedures were successfully completed with no surgical time delays, no surgical/medical interventions, finished the procedures with the devices, everything was fine, both patient's status/outcomes are good.It was during the one, two, three month's of follow-up appointments with the patients that the surgeon took x-rays on unknown dates and noticed that the stems were loosening overtime (the stem that goes into the canal of the radial bone).The surgeon was concerned if this was happening in other cases with other colleagues as well." this report is 1 of 1 for (b)(4).

Manufacturer Narrative

Implant date unknown, not explanted.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: RADIAL HEAD PROSTHESIS SYSTEM
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19680
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5048957
• MDR Text Key: 24797818
• Report Number: 2520274-2015-15612
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2015
• 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: Unknown
• Patient Sequence Number: 1