MAUDE Adverse Event Report: SYNTHES MONUMENT 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL POLYMER

Catalog Number 09.402.020S

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Exact date of implant procedure is unknown.Sometimes in (b)(6) 2015.Complainant part is not expected to be returned for manufacturer review/investigation.Device history records review for part # 09.402.020s, lot# 6892356 supplier lot# 95952 was completed.Release to warehouse date: aug 31, 2012, expiration date: jun 30, 2017, supplier: (b)(4).No non conformance reports were generated relevant to the complaint condition.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device 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 patient had a radial head prosthesis (head and stem) implanted in (b)(6) of 2015.On an unknown date, the patient presented for a follow up complaining of pain.The implant appeared to have loosened.On (b)(6) 2016, patient underwent revision surgery and all implants were removed.No other information reported.This report is for one (1) radial head.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device 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.

• Brand Name: 20MM COCR RADIAL HEAD STANDARD HEIGHT/12.0MM-STERILE
• 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6022704
• MDR Text Key: 57159950
• Report Number: 1719045-2016-10752
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2016

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
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: 09.402.020S
• Device Lot Number: 6892356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR