MAUDE Adverse Event Report: SYNTHES (USA); PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Fracture, Arm (2351)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of radial fracture is not known.510k: this report is for an unknown radial stem.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device code (b)(4) used to capture stem loosening as determined from x-ray.X-rays were reviewed by the medical safety officer and it was identified that the radial stem loosened which likely contributed to the reported event.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.

Event Description

It was reported that a radial head prosthesis was removed on (b)(6) 2017.The date of the original right radial head repair procedure was (b)(6) 2015.On an unknown date prior to the hardware removal, the patient sustained a fracture of the right radius while lifting a sixty-five pound chair.The patient heard a "pop" and it was subsequently identified that he had fractured the right radius - at the end of the radial stem.The removed hardware included one 26mm "+0" radial head and one 7mm curved radial stem - both fully intact and in one piece.No new hardware was implanted; this was a radial head excision.Nothing untoward occurred during the procedure.It was completed successfully with no surgical delay and with the patient in stable condition.This report is for one (1) unknown 7mm curved radial stem this is report 1 of 1 for (b)(4).

Manufacturer Narrative

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.

Event Description

It was reported that a radial head prosthesis was removed on (b)(6) 2017.The date of the original right radial head repair procedure was (b)(6) 2015.On an unknown date prior to the hardware removal, the patient sustained a fracture of the right radius while lifting a sixty-five pound chair.The patient heard a ¿pop¿ and it was subsequently identified that he had fractured the right radius ¿at the end of the radial stem.The removed hardware included one 26mm ¿+0¿ radial head and one 7mm curved radial stem ¿both fully intact and in one piece.No new hardware was implanted; this was a radial head excision.Nothing untoward occurred during the procedure.It was completed successfully with no surgical delay and with the patient in stable condition.It is noted that prior to the hardware removal, the patient reported a positive experience regarding his radial head prosthesis.Concomitant devices reported: radial head - 26mm ¿+0¿ head (part # unknown, lot # unknown, quantity # 1).This report is for one (1) unknown 7mm curved radial stem.This is report 1 of 1 for (b)(4).

• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6677944
• MDR Text Key: 78770412
• Report Number: 2520274-2017-11900
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• 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: 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 112