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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY 44MM PROSTHESIS, SHOULDER

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BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY 44MM PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Code Available (3191)
Event Date 01/30/2012
Event Type  Injury  
Event Description

It was reported that patient underwent reverse total shoulder arthroplasty on (b)(6) 2010. Subsequently, patient reached behind driver's seat while in automobile and the humeral tray fractured at the trunnion. A revision procedure was performed to remove the fractured humeral tray on (b)(6) 2012. A custom-made humeral tray was implanted four days after the revision procedure.

 
Event Description

It was reported that patient underwent reverse total shoulder arthroplasty on (b)(6) 2010. Subsequently, patient reached behind driver's seat while in automobile and the humeral tray fractured at the trunnion. A revision procedure was performed to remove the fractured humeral tray on (b)(6), 2012. A custom-made humeral tray was implanted four days after the revision procedure. According to the information provided in the attached user facility medwatch report, the revision procedure occurred on (b)(6), 2012.

 
Manufacturer Narrative

Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, trauma, non-union, or excessive weight. " evaluation of the returned component found scratches on the distal humeral tray typical of post-fracture damage. The post fracture damage has obfuscated most fracture artifacts that could assist in finding a probably origin and cause of the tray fracture. The user facility was notified of the event. Should the user facility provide additional information and/or submit a medwatch report, biomet will forward a supplemental report to the fda.

 
Manufacturer Narrative

User facility forwarded a report after receiving a faxed letter from biomet on (b)(4), 2012 with event details. This follow-up report is being filed to make the fda aware that both the manufacturer report number and user facility report are for the same patient, part number and event.

 
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Brand NameCOMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY 44MM
Type of DevicePROSTHESIS, SHOULDER
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 east bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 east bell drive
warsaw IN 46582
Manufacturer Contact
angela dickson
56 east bell drive
warsaw, IN 46582
5743711021
MDR Report Key2511642
MDR Text Key2575914
Report Number0001825034-2012-00352
Device Sequence Number1
Product Code KWS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK080642
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/29/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/30/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue Number115340
Device LOT Number846230
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/29/2012
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/29/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/31/2010
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 03/30/2012 Patient Sequence Number: 1
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