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

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(6).Event date: unknown.This report is for one, unknown radial stem.Part and lot numbers were not provided for reporting.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The 510(k): unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number a device history record (dhr) review could not be completed.The date of manufacture is unknown.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 the patient underwent a revision surgery on (b)(6) 2015 to remove a radial head due to loosening of the radial stem.No information provided on whether the patient had symptoms related to the loose device.The patient was originally implanted with the devices on (b)(6) 2014.During the revision the radial head and radial stem were removed whole and intact.Reportedly, a post-operative routine x-ray showed the area had been resected and new devices were not implanted.There was no reported surgical delay.The revision surgery was successfully completed.The patient outcome was stable.Concomitant device reported: radial head (part # unknown, lot # unknown, qty 1).This report is for one, unknown radial stem.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Complaint was reviewed and determined to be a part of recall.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: 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: 6379633
• MDR Text Key: 69095657
• Report Number: 2520274-2017-10733
• 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,Followup
• Report Date: 02/07/2017

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 03/05/2017
• Supplement Dates Manufacturer Received: 10/12/2017
• Supplement Dates FDA Received: 10/12/2017
• 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: UNKNOWN RADIAL HEAD, QTY 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 64