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U.S. Department of Health and Human Services

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

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SYNTHES USA PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER Back to Search Results
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. It was reported that the patient is experiencing a decreased range of motion and delayed healing. This report is for an unknown 8mm stem. This report is 2 of 3 for (b)(4).

 
Manufacturer Narrative

Device was used for treatment, not diagnosis. This report is for one unknown 8 mm stem/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.

 
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Type of DevicePROSTHESIS, 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 Key4040097
Report Number2520274-2014-13313
Device Sequence Number1
Product CodeKWI
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
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 Received08/27/2014
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 Received07/31/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 08/27/2014 Patient Sequence Number: 1
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