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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING PROSTHESIS, SHOULDER

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BIOMET ORTHOPEDICS COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING PROSTHESIS, SHOULDER Back to Search Results
Model Number N/A
Event Date 04/19/2011
Event Type  Injury  
Event Description

It was reported that patient underwent reverse shoulder arthroplasty on (b)(6) 2009. Subsequently, patient rolled over in bed and heard a loud pop. Radiographs revealed a possibly broken humeral tray. Patient was revised on (b)(6) 2011, due to fracture of the humeral tray. The humeral tray was removed and replaced.

 
Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, (b)(4) states, "fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, malalignment, bone resorption and/or excessive activity. " the humeral tray arrived assembled to the humeral bearing and the fractured taper was still embedded in the stem. No effort was made to disassemble the two components. The inferior side of the humeral tray shows what appear to be scratches, gouges, and other wear marks, which are probably post-fracture damage. Post-fracture damage on the fracture surfaces has obfuscated artifacts that might have determined a probable failure mode and fracture origin. The few artifacts that remain suggest that the fracture could have started in fatigue. The fractured taper is still embedded in the stem. Although the probable post-fracture damage of the fracture surface has obfuscated most of the artifacts that could have suggested a fracture cause and origin, a few ratchet marks suggest the fracture may have started in fatigue. The user facility was notified of the event on (b)(6) 2011. To date, a response has not been received from the user facility. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda. (b)(4).

 
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Brand NameCOMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY WITH LOCKING RING
Type of DevicePROSTHESIS, SHOULDER
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46581 058
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46581 058
Manufacturer Contact
craig buchman
56 e. bell drive
warsaw , IN 46581
5743711132
MDR Report Key2135641
Report Number1825034-2011-00518
Device Sequence Number1
Product CodeKWS
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 05/27/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date10/31/2018
Device MODEL NumberN/A
Device Catalogue Number115340
Device LOT Number216000
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/03/2011
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/27/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/17/2008
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/21/2011 Patient Sequence Number: 1
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