MAUDE Adverse Event Report: SYNTHES USA 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE; PROSTHESIS, ELBOW, HEMI- RADIAL, POLYMER

Catalog Number 04.402.008S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Impaired Healing (2378); Limited Mobility Of The Implanted Joint (2671)

Event Date 07/31/2014

Event Type  Injury  

Event Description

Patient had a radial head replacement surgery on (b)(6) 2014.The patient received a radial head prosthesis.This was an opened injury, other specifics of the injury are unknown.At 6 weeks postoperative, after an x-ray the patient was given permission to start using the arm.The second x-ray was done on (b)(6) 2014, that showed the 8 millimeter (mm) stem had cut out of the lateral radius.The patient stated that he had been 100 percent compliant with postoperative instructions.A revision will be done eventually.Timeframe of revision unknown.I was reported that the patient is experiencing a decreased range of motion and delayed healing.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for one unknown radial head prosthesis/unknown lot number.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.

• Brand Name: 8MM TI STRAIGHT RADIAL STEM 28MM-STERILE
• Type of Device: PROSTHESIS, ELBOW, HEMI- RADIAL, POLYMER
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4040119
• MDR Text Key: 4861297
• Report Number: 2520274-2014-13311
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.402.008S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2014
• 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