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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN BIOMET M2A ACETABULAR CUP PROSTHESIS, HIP

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BIOMET ORTHOPEDICS UNKNOWN BIOMET M2A ACETABULAR CUP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Event Type  Injury  
Event Description

It was reported that patient underwent m2a hip arthroplasty on unknown date. Subsequently, the patient was revised in (b)(6) 2011, due to pain. During the revision procedure, the surgeon noted that the acetabular cup had no bony ingrowth.

 
Manufacturer Narrative

Event date - (b)(6) 2011. Implanted date - unknown. Explanted date - (b)(6) 2011. The user facility is outside of the united states. No medwatch report was received. Current information is insufficient to permit a conclusion as to the cause of the event. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number four states, "loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity". The product and lot identification necessary to review manufacturing history was not provided.

 
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Brand NameUNKNOWN BIOMET M2A ACETABULAR CUP
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 e. bell drive
warsaw IN 46582
Manufacturer Contact
angela dickson
56 e. bell drive
warsaw , IN 46582
5743711021
MDR Report Key2540994
Report Number0001825034-2012-00465
Device Sequence Number1
Product CodeKWA
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/20/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL NumberN/A
Device Catalogue NumberUNKNOWN BIOMET CUP
Device LOT NumberN/A
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received03/20/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 04/19/2012 Patient Sequence Number: 1
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