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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET ORTHOPEDICS 28MM MOD HD CERAMIC -5MM NK PROSTHESIS, HIP

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BIOMET ORTHOPEDICS 28MM MOD HD CERAMIC -5MM NK PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Discolored
Event Date 12/03/2015
Event Type  Injury  
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. Date implanted - unknown. Device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date. In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results. This report is number 2 of 2 mdr's filed for the same event (reference 1825034-2016-01041 / 01042).

 
Event Description

It was reported patient underwent an initial hip arthroplasty on an unknown date nine years ago. Subsequently, the patient was revised on (b)(6) 2015 due to liner wear. The ceramic head was reported to have been discolored black.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Evaluation in progress.

 
Manufacturer Narrative

This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. (b)(4). Examination of returned device found no evidence of product non-conformance. Review of the device confirmed the reported condition. A conclusive root cause for the event could not be determined.

 
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Brand Name28MM MOD HD CERAMIC -5MM NK
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
megan haas
56 e. bell drive
warsaw , IN 46582
5743726700
MDR Report Key5528533
Report Number0001825034-2016-01042
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/20/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device EXPIRATION Date03/31/2016
Device MODEL NumberN/A
Device Catalogue Number163130
Device LOT Number867340
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/30/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/07/2005
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: 03/28/2016 Patient Sequence Number: 1
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