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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS M2A MAGNUM PF CUP 58MM O.D. X 52MM I.D. PROSTHESIS, HIP

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BIOMET ORTHOPEDICS M2A MAGNUM PF CUP 58MM O.D. X 52MM I.D. PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Implant, removal of
Event Date 02/23/2010
Event Type  Injury  
Event Description

It was reported that the patient underwent total hip arthroplasty on (b) (6) 2009. Revision surgery was performed on (b) (6) 2010, due to clunk and leg length inequality. As part of the revision surgery, the m2a magnum pf cup and m2a magnum modular head were replaced.

 
Event Description

It was reported that patient underwent total hip arthroplasty on (b) (6) 2008. Revision surgery was performed on (b) (6) 2010 due to clunk and leg length inequality. As part of the revision surgery, the m2a magnum pf cup and m2a magnum modular head were replaced.

 
Event Description

It was reported that the patient underwent total hip arthroplasty on (b) (6) 2009. Revision surgery was performed on (b) (6) 2010, due to clunk and leg length inequality. As part of the revision surgery, the m2a magnum pf cup and m2a magnum modular head were 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 or deviation. There are warnings in the package insert that state that this type of event can occur. (b) (4).

 
Manufacturer Narrative

Date implanted - (b) (6) 2008. (b) (6).

 
Manufacturer Narrative

User facility forwarded a report after receiving a faxed letter from biomet on april 13, 2010 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 number referenced in this medwatch are for the same patient, part number and event. User facility report states that device is available for evaluation. To date, device has not been returned to biomet. Follow-up was conducted to obtain the device and it was relayed that it has been sent to a third party for evaluation. (b) (4).

 
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Brand NameM2A MAGNUM PF CUP 58MM O.D. X 52MM I.D.
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
BIOMET ORTHOPEDICS
56 east bell drive
p.o. box 587
warsaw IN 46581 058
Manufacturer (Section G)
BIOMET ORTHOPEDICS
56 east bell drive
p.o. box 587
warsaw IN 46581 058
Manufacturer Contact
miranda parcels
56 east bell drive
p.o. box 587
warsaw , IN 46581-0587
5742676639
MDR Report Key1664932
Report Number1825034-2010-00124
Device Sequence Number1
Product CodeKWA
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/30/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date09/30/2017
Device MODEL NumberN/A
Device Catalogue NumberUS157858
Device LOT Number860180
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date04/13/2010
Device Age2 yr
Event Location Hospital
Date Manufacturer Received03/30/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/10/2007
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: 04/22/2010 Patient Sequence Number: 1
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