MAUDE Adverse Event Report: SYNTHES MONUMENT; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date of device loosening is not known.This report is for an unknown radial stem.Part and lot numbers are unknown; udi number is unknown.Date of implant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant device therapy date is not known.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 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 and stem was explanted on (b)(6) 2017 due to the radial stem loosening.Radiographs taken on unknown date revealed the radial stem was loose in the distal radial canal-left.The original implant date is unknown.The devices were removed still connected to each other.There were no surgical delays, no additional medical intervention required and no harm to the patient during the procedure.The devices were not separated and were sent to pathology joined.The devices are not available for investigation but pictures of the radiographs will be forwarded for review.The patient was reported to be in post-op, in stable condition, and has not experienced any further complications.There are no plans to implant any additional devices at this time.Concomitant devices reported: radial head (quantity 1).This report is for one (1) unknown radial stem.This is report 1 of 1 for (b)(4).

• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6744189
• MDR Text Key: 81048314
• Report Number: 1719045-2017-10697
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• 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
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• 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: 06/28/2017
• 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
• Treatment: RADIAL HEAD (PART AND LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Weight: 121