MAUDE Adverse Event Report: SYNTHES USA 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Catalog Number 09.402.024S

Device Problem Fitting Problem (2183)

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

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.(b)(4).Device is not expected to be returned for manufacturer review/investigation.(b)(4): the complaint indicated that the radial head was determined to be too large which was identified post-op and there was a possible infection which required additional surgical intervention.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 a patient initially underwent surgery in (b)(6) 2016 for the placement of a left variable angle proximal ulna plate with nine screws and a 24mm radial head and long stem, unknown size, prosthesis by another surgeon.The patient was brought back to the operating room on (b)(6) 2016 for a possible infection at the site of the plate and screws and because the radial head was determined to be too large.The stem size was reported to be ok.It was reported that the fracture had healed and therefore, the hardware was not replaced.A specimen was obtained and results are pending.Regarding the radial head and stem, the surgeon was only able to remove the radial head but was unsuccessful in removing the stem (see (b)(4)).This complaint is for 4 devices.This report is 1 of 4 for (b)(4).

Manufacturer Narrative

Date correction from (b)(6) 2016 to (b)(6) 2016.Change to original implant date was reported as sometime in (b)(6) 2016.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: 24MM COCR RADIAL HEAD STANDARD HEIGHT/13.0MM-STERILE
• 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: 6224124
• MDR Text Key: 63910146
• Report Number: 2520274-2017-10036
• 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
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09.402.024S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR
• Patient Weight: 102